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Measures | All participants received an email with a link to an online assessment battery at baseline, postintervention and 3 months follow-up. None of the research team had access to these data prior to the final analysis, ensuring independence of assessments. | PMC10577780 | ||
Primary outcome | depressive, Depression, Anxiety, anxiety | We assessed the primary outcomes of anxiety and depressive symptoms with the Hospital Anxiety and Depression Scale (HADS | PMC10577780 | |
Secondary outcomes | Anxiety, worry, anxiety | DISORDER | Generalised anxiety and worry were assessed with the Generalised Anxiety Disorder Scale (GAD-7 | PMC10577780 |
Statistical analyses | The sample size was calculated on the basis of prior trials of group-based interventions delivered during the pandemic,We assessed potential differences between participants across treatment arms using planned t-tests for continuous measures and χ | PMC10577780 | ||
Results | PMC10577780 | |||
Baseline characteristics of participants | anxiety disorder, Anxiety, anxiety, caseness, Insomnia, depression, Depression | DISORDER, DISORDER | Between 10 December 2020 and 16 September 2021 (with final 3-month follow-up assessment completed on 18 February 2022), 174 participants were enrolled into the trial. The majority of participants were female (83.9%), and were university educated (71.3%). In terms of caseness of psychological problems, 85.1% met the cut-off for probable depression (2.3% for severe depression), 79.3% for probable anxiety disorder (1.7% for severe anxiety), 32.0% for generalised anxiety disorder. There were 87 participants randomised to the intervention and 87 to EUC. Participants in the intervention and EUC did not differ at baseline on any sociodemographic characteristics or baseline psychopathology measures (Study flow diagram. EUC, enhanced usual care.Demographic and participant characteristicsModerate/Severe depression=HADS-Depression Scale score ≥15. Moderate/Severe anxiety=HADS-Anxiety Scale score ≥15. Generalised anxiety disorder=GAD-7 score ≥15. Insomnia=Sleep Impairment Index score ≥10.GAD-7, Generalised Anxiety Disorder Scale; HADS, Hospital Anxiety and Depression Scale. | PMC10577780 |
Primary outcome | Anxiety, anxiety, Suicidality, Suicidal Ideation, depression, Depression | DISORDER, SECONDARY, POSITIVE | At 3 months participants in the intervention arm reported greater reductions in depression on the HADS (mean difference 1.2 (95% CI 0.4 to 1.9), p=0.003), with a moderate effect size (0.5 (95% CI 0.2 to 0.9)). There was no between-group difference on anxiety on the HADS (Summary statistics and results from mixed model analysis of primary and secondary outcomesEffect size was calculated by the difference in least square means between intervention and EUC from mixed model divided by the pooled SD.Sleep Impairment Index (total score range: 0–20; higher scores indicate more severe sleep impairment).COVID Concerns Scale, COVID-19 Stress Scale (each scale total score range: 0–24; higher scores indicate more severe stress); EUC, enhanced usual care; GAD-7, Generalised Anxiety Disorder Scale (total score range: 0–21; higher scores indicate more severe worry); HADS, Hospital Anxiety and Depression Scale (depression subscale score range: 0–21; anxiety subscale score range: 0–21; higher scores indicate elevated anxiety or depression); LS, least square; PANAS, Positive and Negative Affect Schedule (subscale total score range: 10–50 on positive and negative scales, respectively; higher scores indicate more greater positive and negative mood, respectively); Quality of life, Australian Quality of Life Scale (total score range: 20–100; higher scores indicate poorer quality of life); Suicidality, Suicidal Ideation Attributes Scale (total score range: 0–50; higher scores indicate more severe suicidality). | PMC10577780 |
Secondary outcomes | In terms of suicidality, the intervention led to greater reduction difference at 3-month follow-up (mean difference 4.8 (95% CI 1.32 to 8.4), p=0.008), indicating a moderate effect size (0.4 (95% CI 0.1 to 0.8) ( | PMC10577780 | ||
Subgroup analyses | depression, anxiety | There were 148 participants who reported probable depression or anxiety at baseline; these were equally distributed between the intervention (77, 88.5%) and EUC (71 (81.6%). In terms of analyses that focused on these participants ( | PMC10577780 | |
Sensitivity analyses | suicidality, depression | ADVERSE EVENTS | The sensitivity analysis that focused only on participants who completed the 3-month follow-up indicated that in terms of primary outcomes, the intervention led to greater reductions than EUC for depression and suicidality, and greater increase in quality of life (There were no adverse events throughout the trial. | PMC10577780 |
Data availability statement | Data are available on reasonable request. Data will be available for meta-analysis and other reasonable requests from RB (r.bryant@unsw.edu.au) | PMC10577780 | ||
Ethics statements | PMC10577780 | |||
Patient consent for publication | Not applicable. | PMC10577780 | ||
Ethics approval | This study was approved by University of New South Wales Human Research Ethics Committee (HC200670). Participants gave informed consent to participate in the study before taking part. | PMC10577780 | ||
References | PMC10577780 | |||
Background | autistic, Autistic, Autistic Traits | Autistic people demonstrate focused interests, sensitivity to sensory stimulation, and, compared with the general population, differences in social communication and interaction. We examined whether a combination of the Awareness and Care for My Autistic Traits (ACAT) program and treatment-as-usual is more effective than only treatment-as-usual in increasing the understanding of autistic attributes, reducing treatment stigma, and improving mental health and social adaptation among autistic adolescents and their parents/guardians. | PMC10485995 | |
Methods | autistic, Autism | SECONDARY, BLIND | Forty-nine adolescents and their parents/guardians were randomly assigned to either a combination of ACAT and treatment-as-usual or only treatment-as-usual. The combined group received six weekly 100-minute ACAT sessions, while the treatment-as-usual group received no additional intervention. The primary outcome was the change in understanding of autistic attributes (Autism Knowledge Quiz-Child), administered from pre- to post-intervention. The secondary outcomes included the change in Autism Knowledge Quiz-Parent, reduced treatment stigma, and improved mental health and social adaptation among autistic adolescents and their parents/guardians. A primary outcome measure scale was scored by assessors who were blind to the group assignment. | PMC10485995 |
Results | Autistic, autistic adolescents, Autism | The combined group (both autistic adolescents and their parents/guardians) showed an increase in Autism Knowledge Quiz scores compared to those in the treatment-as-usual group. Autistic adolescents in the combined group also demonstrated a decrease in treatment-related stigma and an improvement in general mental health compared to those in the treatment-as-usual group, while there were no group differences in the change in social adaptation. For parents/guardians, there were no group differences in the change in treatment-related stigma, general mental health, adaptive skills, or attitudes toward their children. | PMC10485995 | |
Conclusions | autistic, autistic adolescents | The ACAT program could be an effective treatment modality to increase the understanding of autistic attributes among both autistic adolescents and their parents/guardians. The ACAT program positively affects self-understanding, reduces treatment stigma, and stabilizes behavioral issues for autistic adolescents as a part of mental health measures, but it does not effectively reduce treatment barriers or improve mental health for parents/guardians. Further research should consider whether additional support for parents/guardians could be beneficial. | PMC10485995 | |
Trial registration | : The study was registered in UMIN (UMIN000029851, 06/01/2018). | PMC10485995 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12888-023-05075-2. | PMC10485995 | ||
Keywords | PMC10485995 | |||
Background | PMC10485995 | |||
Autistic people and their mental health | Autistic | Autistic people demonstrate focused interests, sensitivity to sensory stimulation, and, as compared with the general population, differences in social communication and interaction [ | PMC10485995 | |
Psychological interventions for improving autistic individuals’ mental health | autistic, comorbid psychiatric disorders | Various interventions are used to treat social maladjustment and comorbid psychiatric disorders in autistic individuals. For example, psychotherapy, such as cognitive-behavioral therapy (CBT) and social skills training, can be administered to improve coping skills and environmental adjustment [ | PMC10485995 | |
Potential of psychological interventions to enhance autistic self-perception | autistic, ’, autism | Stigma against autism among parents/guardians may prevent autistic adolescents from receiving reasonable accommodations, which in turn, may increase their psychological burden. Destigmatizing the attitudes of parents/guardians is important to lower autistic individuals’ treatment stigma as parents/guardians can help children perceive their autistic characteristics more positively through open discussions [Importantly, Riccio et al. [ | PMC10485995 | |
Psychoeducation program to improve self-understanding of autistic traits | autistic traits, Autism | The Psychoeducation Group for Autism Spectrum Understanding and Support (PEGASUS) in the UK is one of the few evidence-based, structured family psychoeducation programs for autistic traits worldwide [ | PMC10485995 | |
Development of a new program on awareness and coping strategies for autistic traits using CBT | autistic traits, anxiety, Autism, autistic, depression | CBT is an evidence-based treatment for children, adolescents, and adults who have mental health issues such as depression and anxiety. It can be modified and applied to treat mental health issues in autistic children [
Similarities and differences between the PEGASUS and ACAT programIncreasing the recipient’s awareness of a child’s autistic traitsUnderstanding the child’s autistic responsesPracticing problem-solving skillsOne session/week for six sessionsEach session lasts 90 minOne session/week for six sessionsEach session lasts 100 minAdditional sessions before the first session and follow-up sessionGroup discussion Children’s group: After attaining general knowledge about autistic traits, the group discusses the strengths, weaknesses, and characteristics of children’s autistic traits in the unit “autistic traits and me. They also discuss compensation strategies for autistic traits.Parents’ group: The group reflects on the impact of autistic traits on their family and the surrounding environment. They also discuss potential resources and networks around the child and family.Co-psychoeducation and CBT1. Psychoeducation on autistic traits2. Using the CBT model3. Discuss problem-solving methods and plan what kind of problem-solving strategies will improve the child’s adjustment. See Table The objective of this study was to evaluate the effectiveness of the ACAT intervention compared to treatment-as-usual (TAU). The specific hypotheses were as follows:
Adolescents and parents/guardians assigned to the combined ACAT and TAU (COMB) group would show improved Autism Knowledge Quiz (AKQ) scores compared to those assigned to the TAU group alone.Adolescents assigned to the COMB group would show reduced treatment stigma and improved mental health, including coping strategies and social adaptation, compared to those in the TAU group.Parents/guardians assigned to the COMB group would show an increased awareness of children’s autistic traits and improved mental health and adaptive skills to deal with their children’s challenges compared to those in the TAU group. | PMC10485995 | |
Methods | This study was designed as a prospective, randomized, and assessor-blinded endpoint trial with two parallel intervention groups—COMB and TAU—consisting of a six-week intervention for both groups conducted as a multisite study.We evaluated outcomes at pre-intervention (0 weeks), post-intervention (6 weeks), and follow-up (10 weeks). The Chiba University Research Ethical Review Committee approved this trial (CRB3180015, No. G29027). All procedures were carried out in accordance with relevant guidelines and the regulations of the Declaration of Helsinki. | PMC10485995 | ||
Randomization | MH, autistic traits | Participants were allocated to either the intervention group (ACAT + TAU) or control group (TAU + waiting list to intervention) in a 1:1 ratio using the minimization method, based on gender (boy, girl, or other) and awareness of their autistic traits by the AKQ-Child (AKQ-C) (total score more or less than 2.4) at baseline. The randomization procedure was conducted by Chiba University Hospital’s independent data management team using a computer program. Participants allocated to the control group were informed that they could receive the ACAT program after this randomized controlled trial was completed. Therapists and participants were not blinded to their group assignment; however, two trained testers, MH and MS, who assessed only the AKQ-C and AKQ-Parent (AKQ-P), were blinded to the groups. | PMC10485995 | |
Participants | Autism, degenerative physical disorder, psychiatric, autistic, autism | DISORDERS, DISORDERS | The adolescents and parents/guardians provided written and verbal informed consent using the form and protocol approved by the Chiba University Clinical Research Ethical Review Committee. The inclusion criteria for adolescents were: (1) diagnosed with autism by their general practitioners using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and met the cut-off value for autism measured using the Autism Diagnostic Observation Schedule (ADOS-2) [The exclusion criteria for autistic adolescents were: (1) suicidal intentions at the time of enrolment; (2) a repetitive behavioral problem and/or severe degenerative physical disorder, as identified by a primary psychiatrist; (3) any other condition that might compromise well-being. The exclusion criterion for parents/guardians was meeting the diagnostic criteria for psychiatric disorders, assessed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) [ | PMC10485995 |
Sample size | In a previous study by Gordon et al. [ | PMC10485995 | ||
Intervention groups | PMC10485995 | |||
COMB group | autistic traits, autistic traits.οNaming the autistic traitsοTo, autistic traitsο Case formulations, autistic, cognitive and behavioral changes, adaptation?ο | SESSION | The ACAT program is an individual CBT intervention conducted once a week for 100 min each time [
Outline of ACAT components across the six-week programThemesο Session contentSession goalsο Required CBT techniquesLearn about your psychological assessment for autismο Sharing the results of psychological assessment testsο Learn about ASD/ADHDο Learn about the aims of the ACAT program.ο Outline the current problemLearning about their characteristics and autistic traits through the results of assessment testsο Monitoringο ExternalizationLearn about the characteristics of your autistic traitsο What is social and psychological adaptation?ο What is CBT?ο To understand the link between autistic traits and maladaptive problemsUnderstanding the differences between autistic attributes and typical developmental featuresο Monitoringο ExternalizationCognitive changes: Learn not only about the “weakness” but also the “strengths” of your autistic traitsο To understand the strengths and weaknesses of autistic traitsο To understand the link between autistic traits and maladaptive problems based on the cognitive behavioral modelDiscovering the “strengths” of autistic traits, setting aside the “weaknesses” and turning negative perspectives into rational neutral understanding about themselves.ο Monitoringο Externalizationο Case formulationsCognitive changes: Create “funny nicknames” for your autistic traits.οNaming the autistic traitsοTo understand the link between autistic traits and maladaptive problems based on the cognitive behavioral modelLearning to externalize their autistic characteristics, facilitate self-monitoring skills, and develop metacognition.ο Monitoringο Externalizationο Case formulationsBehavioral changes: Create a problem-solving plan for your autistic traitsο Case formulations in CBT models to identify patterns of maladaptive problemsLearning how they can change and adjust problematic behaviors to cope with their autistic traitsο Case formulationsBehavioral changes: Plan a functional way to solve easy problems that are caused by your autistic traits with your parentsο Plan and practice coping strategies (cognitive and behavioral changes: reasonable accommodation) based on the CBT modelMake problem-solving plans for their autistic traits and will also consider how to cope with problems when they execute their plans. Starting with easier problems related to their autistic traits. Conducting these plans as a homework assignment.ο Problem-solving techniquesBehavioral changes: Plan a functional way to solve more complicated problems that are caused by your autistic traits with your parentsο Plan and practice coping strategies (cognitive and behavioral changes: reasonable accommodation) based on the CBT modelο A summary of what we have done up to nowMake problem-solving plans for their autistic traits and will also consider how to manage more complicated problems when they execute their plans. Conducting these plans as a homework assignment (this homework assignment will be checked at a follow-up session).ο Problem-solving techniquesCheck how well you are living with your autistic traitsο Review what you have done in the ACAT programο Identify patterns of future coping strategies and develop a perspective on coping after the sessionReviewing all skills and techniques learned to date. Check their understanding of their autistic traits and discuss the progress made in therapy, areas of continued effort, and ongoing challenges.ο Monitoringο Case formulationsο Problem-solving techniques | PMC10485995 |
TAU | The participants in the TAU group received no intervention from the research team. TAU involved regular 10-minute counseling sessions with a psychiatrist and, in some cases, medication and other coping therapies. | PMC10485995 | ||
Assessment and outcomes | PMC10485995 | |||
Participant characterization | PMC10485995 | |||
ADI-R | ADI-R | The ADI-R [ | PMC10485995 | |
ADOS-2 | The ADOS-2 [ | PMC10485995 | ||
WISC-IV | The WISC-IV [ | PMC10485995 | ||
M.I.N.I. | The MINI [ | PMC10485995 | ||
Adolescents’ outcome measures | PMC10485995 | |||
Primary outcome | autistic | AKQ-C. The English AKQ-C [The AKQ-C was administered to autistic adolescents at pre-intervention (week 0: before starting the first session), post-intervention (week 6: when they completed six sessions), and follow-up (week 10: one month after the completion of sessions). The change in AKQ-C scores from pre- to post-intervention was considered the primary outcome. | PMC10485995 | |
Secondary outcomes | Depression | SECONDARY | As secondary outcomes for adolescents, self-report and parent/guardian-report questionnaires and semi-structured interviews for parents were used, and as secondary outcomes for parents/guardians, only self-report questionnaires were used to assess the efficacy of the interventions.Barriers to Access to Care Evaluation scale version 3. The Barriers to Access to Care Evaluation Scale version 3 (BACE-3) [Depression Self-Rating Scale for Children. The Depression Self-Rating Scale for Children (DSRS-C) [SDQ. The SDQ [Vineland Adaptive Behavior Scales Second Edition. The Vineland Adaptive Behavior Scales Second Edition (Vineland-II) [ | PMC10485995 |
Secondary outcomes for parents/guardians | PMC10485995 | |||
AKQ-P | Like the AKQ-C [ | PMC10485995 | ||
BACE-3 | Similar to the assessment of adolescents, the BACE-3 was administered to their parents/guardians at three time points: pre-intervention, post-intervention, and follow-up. | PMC10485995 | ||
General health questionnaire | The General Health Questionnaire 12 (GHQ-12) [ | PMC10485995 | ||
Parenting resilience elements questionnaire | The Parenting Resilience Elements Questionnaire (PREQ) [ | PMC10485995 | ||
Other measures | Adherence to the ACAT manual and CBT were measured using the Revised Cognitive Therapy Scale (CTS-R) [ | PMC10485995 | ||
Recruitment and participant flow | autism | RECRUITMENT | From March 2018 to August 2020, recruitment, treatment, and data collection were conducted in Chiba and Fukushima, Japan. Adolescent outpatients (10–17 years) had been diagnosed with autism using gold-standard instruments such as the ADOS-2 and ADI-R. Their parents/guardians were informed about the intervention in the waiting rooms at Chiba University Hospital and a local psychiatry clinic. For those who showed interest, more information was provided by the recruitment staff (FO and NT), and parents/guardians of prospective research participants contacted the researchers either by phone or email address.The CONSORT flow of participants throughout the trial is shown in Fig.
The flow of participants through the trial | PMC10485995 |
Statistical analyses | All statistical analyses were performed as pre-registered [ | PMC10485995 | ||
Results | autism spectrum disorder, learning disorder, attention-deficit/hyperactivity disorder | The demographic information for participants and parents/guardians in each group is provided in Table
Characteristics of the participantsADHD, attention-deficit/hyperactivity disorder; ASD, autism spectrum disorder; LD, learning disorder.Of the guardians participating in this study, 44 were mothers and one was a father. Their average age was 45.7 years, with an average of 14.3 years of education, and 14.4% were in full or part-time employment. Eight of the 44 participants had received support services such as parent training. Detailed information regarding these demographics is provided in Table
Characteristics of guardians | PMC10485995 | |
Adherence to the ACAT manual and CBT | All ACAT activities were performed according to the manual [ | PMC10485995 | ||
Baseline characteristics | Depression, Autism | The demographic characteristics of the COMB and TAU groups are summarized in Tables 3 and 4. There were no significant differences in demographic characteristics at baseline, except for the participants’ age of consent (COMB: 12.8 years, TAU: 14.1 years,
Outcomes at baseline, post-intervention, and follow-up1.51(0.6(-1.37(-0.25(-0.46(AKQ-C, Autism Knowledge Quiz-Child; AKQ-P, Autism Knowledge Quiz-Parent; Vineland-II, Vineland Adaptive Behavior Scales Second Edition; SDQ, Strengths and Difficulties Questionnaire; GHQ-12, The 12-item General Health Questionnaire; DSRS-C, Depression Self-Rating Scale for Children; BACE-3 C, Barriers to Access to Care Evaluation scale, version 3 for children; BACE-3P, Barriers to Access to Care Evaluation scale, version 3 for parents; PREQ, Parenting Resilience Elements Questionnaire. | PMC10485995 | |
Primary outcome | PMC10485995 | |||
Adolescents’ self-awareness of their autistic traits | autistic, autistic traits | The primary outcome was self-awareness of autistic traits in autistic adolescents measured by the AKQ-C. The primary interest was to examine if there was a change in the AKQ-C score from pre- to post-intervention for the COMB group compared with the TAU group. After the intervention, comparing the two groups, the effect size of Cohen’s d, as 1.51 was more significant in the COMB group (Table Comparing an estimate of the effect size of η2 from the COMB group and TAU group using the analysis of covariance with Baseline AKQ-C scores and gender as covariates revealed that the change in the COMB group was larger than in the TAU group (p < .0001, η2 = 0.39) (Table | PMC10485995 | |
Secondary outcomes | PMC10485995 | |||
Awareness of children’s autistic traits among parents and guardians | The COMB group had a large effect size (d = 0.99), with scores increasing from 3.8 (SD = 1.7) at week 0 to 6.4 (SD = 3.0) at week 6. The COMB group also had a greater increase in AKQ-P scores than the TAU group. | PMC10485995 | ||
Treatment stigma in autistic adolescents | We did not observe a change in treatment stigma in adolescents; the average score was 24.1 (SD = 10.6) at week 0 and 13.3 (SD = 8.7) at week 6. There were no differences in the degree of change in BACE-3 scores in the COMB group from week 0 to week 6 (d = -0.46, | PMC10485995 | ||
Treatment stigma in parents/guardians | We did not observe a change in scores from 20.3 (SD = 11.8) at week 0 to 20.1 (SD = 11.8) at week 6. | PMC10485995 | ||
General mental health, depression, and social adaptation in adolescents | There were differences between the COMB and TAU groups regarding the degree of change in general mental health; the average SDQ score in the COMB group reduced from 20 (SD = 4.7) at week 0 to 17 (SD = 5.8) at week 6. The COMB group showed a greater decrease in SDQ scores compared to the TAU group ( | PMC10485995 | ||
Mental health, adaptive skills, and attitudes toward children among parents/guardians | SD | We did not observe a change in parents’ resilience; the average PREQ score was 83.4 (SD = 10.5) at week 0 and 80.3 (SD = 13.8) at week 6. The same was the case with the GHQ-12; we did not observe a change in average scores from 16.4 (5.2) at week 0 to 11.5 (5.2) at week 6 in the COMB group. | PMC10485995 | |
Discussion | autistic, depression, autistic traits, ’ adaptive behavior | The objectives of this study were to evaluate the effectiveness of the ACAT intervention, developed to improve awareness of autistic traits among adolescents and parents/guardians. This would reduce treatment stigma and improve adolescents’ coping skills and social adaptation. We hypothesized that: (1) adolescents and parents/guardians in the COMB group would show improved awareness of autistic traits compared to those in the TAU group; (2) adolescents and parents/guardians in the COMB group would show reduced treatment stigma compared to those in the TAU group; (3) adolescents and parents/guardians in the COMB group would show decreased depression and psychological distress levels, and increased social adaptation, compared to those in the TAU group. As expected, the ACAT program increased awareness of autistic traits both among adolescents and their parents/guardians. In addition, it reduced treatment stigma and negative emotional and behavioral attributes in autistic adolescents. However, there were no effects on adolescents’ adaptive behavior and depression, as well as on treatment stigma, mental health, adaptive skills, and attitudes toward their children among parents/guardians.The ACAT was designed to improve the metacognition of cognitive and behavioral patterns for autistic adolescents by adding the “awareness of autistic traits” to CBT. With this approach, the metacognition of cognitive and behavioral patterns, which is often attenuated in autistic individuals and is difficult to conceptualize in the CBT model, can be targeted. | PMC10485995 | |
Improved awareness regarding autistic traits in adolescents | autistic, autistic traits | The improvement in adolescents’ self-awareness regarding their autistic traits and understanding of their children’s autistic traits among parents/guardians was significantly greater in those who participated in the ACAT program than in those who received TAU. This suggests that the ACAT was effective in helping autistic adolescents and their parents/guardians become aware of the former’s autistic traits, particularly their strengths. CBT involves cognitive and behavioral procedures to understand one’s response patterns through “metacognition,” which is the process of monitoring one’s responses in problem-solving and transforming those response patterns [ | PMC10485995 | |
Reduced treatment stigma in adolescents | autistic, autistic traits, Autism | Treatment stigma was reduced in adolescents in both the COMB and TAU groups. Autism diagnosis may be useful if those who receive it have adequate knowledge and self-understanding of autistic traits, which could improve access to services, help formulation of autistic identity, and guide future planning. However, stigmatization and lower self-esteem [ | PMC10485995 | |
Improvements in general mental health among autistic adolescents | autistic, depression, depressive symptoms | Based on the SDQ scores, in the COMB group, there were improvements in adolescents’ general mental health, but this was not the case with the TAU group. Furthermore, based on the Vineland-II, the social adjustment did not significantly improve in autistic adolescents, but the effect size was moderate (d = 0.60). These findings suggest that the ACAT program was effective for the general mental health of autistic adolescents but not for their social adjustment. Contrastingly, the change in the score of depressive symptoms was not significantly different between the COMB and TAU groups, and the effect sizes were low (d = 0.03, d = 0.08). The average DSRS-C score in the COMB and TAU groups was 16.8 and 16.6, respectively, below the cut-off of 19.3 for current depression [Employing the therapeutic process of CBT, cognitive and behavioral strategies can be created through increased awareness of problems (metacognition and cognition) [ | PMC10485995 | |
Improved awareness of autistic traits in parents/guardians | autistic, autistic traits |
The increase in awareness of their children’s autistic traits among parents/guardians (AKQ-P) between week 0 and week 6 was significantly higher in the COMB group than in the TAU group. This indicates that the ACAT program can help parents/guardians understand and recognize their children’s autistic traits. However, in the COMB group, parents/guardians’ mental health, stigma-related barriers to treatment-seeking behaviors, and parenting resilience did not significantly improve. Parents of autistic children tend to experience more stress and are more susceptible to negative outcomes than parents of children with other disabilities [ | PMC10485995 | |
Limitations | autistic, autistic traits, psychiatric, autism | DISORDER, DISORDERS | This study has several limitations. First, as the sample size was small and diagnostic timing was not considered, we did not control for the presence of other mental disorders. Second, when comparing the ACAT program and TAU, it was unclear which aspects of the former contributed to changes in self-awareness of autistic traits (both in adolescents and parents/guardians) and treatment stigma (only in adolescents). As a next step, we need to conduct a randomized controlled trial of the ACAT program vs. PEGASUS. Third, the study was designed for autistic adolescents with an IQ of ≥ 90 on the VCI, which limits its general versatility. Fourth, we excluded the parents/guardians of autistic adolescents who met the diagnostic criteria for a psychiatric disorder. Parents of autistic youth are more likely to have a psychiatric diagnosis than parents of non-autistic youth and thus, this decision limits the generalizability of the findings to parents/guardians of autistic adolescents. Fifth, the fidelity of the intervention was only measured for about 4% of the total sessions (i.e., 12 of 270 sessions), lower than the standard 10–20% range for intervention studies and thus constitutes a limitation. Sixth, only parents/guardians with no psychiatric disorders were included in the study, and therefore, there is little to no understanding of the intervention’s use in real clinical situations where both children and parents/guardians have autistic traits. Finally, we aimed to clarify the effects of autism awareness and coping skills on stigma and mental health. However, as coping skills were not directly measured, future studies should aim to do this. | PMC10485995 |
Conclusions | autistic traits, anxiety, ’ autistic traits, social behaviors, autistic, depression |
The ACAT program is effective in improving autistic adolescents’ self-awareness of autistic traits, and it can help parents/guardians understand their adolescents’ autistic traits. It also helps improve general mental health and reduce treatment stigma in autistic adolescents. Although we did not observe significant effects on depression and social adaptation for autistic adolescents and treatment stigma, mental health, and parenting resilience for parents/guardians, the ACAT program was useful for improving parent-child communication and an understanding of children’s autistic traits. The effect on parents/guardians was less than that on adolescents. Therefore, improving the intervention for parents/guardians should be considered in the future. Further longitudinal longer-term trials are needed to determine whether the ACAT program can enhance adaptive social behaviors and prevent subsequent mental health issues, such as depression, anxiety, and low self-esteem, for both autistic children and their parents/guardians. | PMC10485995 | |
Electronic supplementary material | autistic, Autistic Traits | Below is the link to the electronic supplementary material.
Supplementary Material 1: Supplementary materials for Awareness and Care for my Autistic Traits (ACAT) program for autistic adolescents: a multicenter randomized controlled trial | PMC10485995 | |
Acknowledgements | Our deep appreciation is extended to Kanae Osumi at the Department of Psychiatry, Hamamatsu University School of Medicine, for their immense contribution to this investigation. | PMC10485995 | ||
Authors’ contributions | FO, study concept and design; WM, guidance in research design; MS, drafting of the manuscript; MH, study therapist; AT, drafting of the manuscript; TO, critical revision of the manuscript; YH, clinical revision of the manuscript; CS, clinical revision of the manuscript; SG, study therapist; YN, study therapist; YO, statistical analysis for study design; YK, statistical analysis for study design; JM, study therapist; NT, study therapist; NS, study therapist; SN, study therapist; AN, diagnosis, and consent for clinical trial enrolments; ES, critical revision of the manuscript. All authors read and approved the final manuscript. | PMC10485995 | ||
Funding | This work was supported by the Association of Japanese Clinical Psychology (Grant Number 2017 S-1). The funder had no role in the design of the study or collection, analysis, or interpretation of data or in writing the manuscript. | PMC10485995 | ||
Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. | PMC10485995 | ||
Declarations | PMC10485995 | |||
Ethics approval and consent to participate | This trial was approved by the Chiba University Clinical Research Ethical Review Committee (CRB3180015, No. G29027). The participating patients and parents provided written and verbal informed consent using the form and protocol approved by the Chiba University Clinical Research Ethical Review Committee. Following a verbal explanation of the trial, participants completed a consent form distributed by the researchers. All methods were performed in accordance with the relevant guidelines and regulations of the Declaration of Helsinki. | PMC10485995 | ||
Consent for publication | Not applicable. | PMC10485995 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10485995 | ||
References | PMC10485995 | |||
Background | DISEASES, ADVERSE EFFECT | To evaluate the effect of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) on female sexual function. Methods: The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2100050887, 07/09/2021). In this prospective cohort study, we prospectively analyzed the data of the female sexual function index (FSFI) questionnaire of 130 patients who underwent laparoscopy in Chengdu Women’s and Children’s Central Hospital due to gynecological benign diseases. The patients were assigned to the vNOTES group and the control group (underwent traditional laparoscopic surgery or transumbilical laparoendoscopic single-site surgery). Results: There were 4 cases dropout in the vNOTES group and 2 cases dropout in the control group. There was no difference in the ages (31.70 ± 5.02 vs. 30.37 ± 5.74, P>0.05), BMI (body mass index, 21.76 ± 3.16 vs. 23.30 ± 2.69, P>0.05), Education level, surgical types, and FSFI scores (22.31 ± 2.25 vs. 21.55 ± 3.38) between the vNOTES group and the control group before surgery. There was no difference in FSFI scores six months postoperation between the vNOTES group and the control group (21.61 ± 3.22 vs. 20.99 ± 3.26, P>0.05), and there was no difference in FSFI scores pre- and six months postoperation in vNOTES group (21.61 ± 3.22 vs. 22.31 ± 2.25, P>0.05). The time to start sexual life after surgery in the vNOTES group was later than that in the control group (39.34 ± 0.71 d versus 37.86 ± 0.69 d, P < 0.05). Conclusions: vNOTES has no significant adverse effect on female sexual function, however, the time to start sexual life after vNOTES is later than that after trans-abdominal laparoscopy. | PMC10398902 | |
Keywords | PMC10398902 | |||
Background | DISEASE, DISEASES, ADVERSE EFFECTS, CAVITY, VAGINA, URETHRA | Natural orifice transluminal endoscopic surgery (NOTES) emerges as a significant innovation in the field of minimally invasive surgery during the last decade, which utilizes the natural orifices of the body surface, such as the mouth, anus, vagina, or urethra, to access the peritoneal cavity [The clinical feasibility of vNOTES in gynecological benign disease surgery have been extensively reported [This study is intended to conduct a prospective cohort study on the sexual function of sexually active women undergoing vNOTES for gynecological benign diseases, thereby determining whether vNOTES exerts adverse effects on the sexual function of female patients and further confirming the effectiveness and safety of vNOTES. | PMC10398902 | |
Methods | This study was approved by the Ethics Committee of Chengdu Women’s and Children’s Central Hospital (No: [2020]164). The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2100050887). All participants provided written informed consent after enrollment. | PMC10398902 | ||
Inclusion criteria | GYNECOLOGICAL DISEASE | 1. From January 1, 2021 to December 31, 2021, nonporous women of reproductive age undergoing laparoscopic surgery for “benign gynecological diseases” in Chengdu Women’s and Children’s Central Hospital; 2. 18–40 years old; 3. Sexually active women who have fixed sex partners, regular sex. | PMC10398902 | |
Exclusion criteria | malignant tumors | MALIGNANT TUMORS | 1. Patients with a previous history of vaginal or cervical surgery; 2. Patients undergoing hysterectomy or subtotal hysterectomy in this surgery; 3. Patients included in the vNOTES group underwent a conversion from vNOTES surgery to trans-abdominal laparoscopy; 4. malignant tumors suggested by postoperative pathological examination. | PMC10398902 |
Assignment of the patients | The assignment of the patients is determined by combining the doctor’s assessment and the patient’s wishes. All patients were assigned to the vNOTES group or control group according to different surgical approaches. The control group included traditional laparoscopic surgery and transumbilical laparoendoscopic single-site surgery. | PMC10398902 | ||
Questionnaire | tubal pregnancy fenestration, adenomyoma of uterus | ADENOMYOMA OF UTERUS | The Female Sexual Function Index (FSFI) is a commonly used sexual functioning questionnaire developed by Rosen et al. [
Baseline characteristicsEducation level[n(%)]Bachelor degree or above43(66.15)Bachelor degree or above34(52.31)Below bachelor degree22(33.85)Below bachelor degree31(47.69)surgical type[n(%)]Ovarian cystectomy19(29.23)Ovarian cystectomy25(38.46)Fallopian tube-related surgery 39(60.00)Fallopian tube-related surgery27(41.54)Uterine related surgery 7(10.77)Uterine related surgery13(20.00)a: BMI: body mass index, vNOTES: transvaginal natural orifice transluminal endoscopic surgery, FSFI: female sexual function indexb: Fallopian tube-related surgery including: salpingectomy, tubal pregnancy fenestration and embryo extraction, tubal ligation, and salpingostomyc: Uterine related surgery: myomectomy and excision of adenomyoma of uterus | PMC10398902 |
Sample size | SECONDARY | The two-sided test was adopted, setting the level of significance alpha at 5% (α = 0.05) and the power of the sample at 80% (β = 0.20). According to the pre-test results, the FSFI scores of the exposure group and control group were 20.87 ± 6.87 and 23.75 ± 5.50 respectively. Considering a dropout rate of 10%, the estimated sample size was N1 = N2 = 65 cases by using PASS 15 software.
FSFI score of patients in vNOTES group pre- and post-operationThe primary outcome was the FSFI score at 3 and 6 months after surgery. The secondary outcome was the time to start sexual life after surgery. The patient’s age, height, weight, surgical type, the time to start sexual life after surgery, the preoperative FSFI score, and the postoperative FSFI score after 3 and 6 months were collected. | PMC10398902 | |
Statistical analysis | SPSS 20.0 statistical software was used for statistical analysis. The measurement data were expressed as mean ± standard deviation such as age, body mass index and FSFI score. The data conforming to normal distribution and homogeneity of variance adopted the | PMC10398902 | ||
Results | A total of 130 patients were included in this study including 65 in the vNOTES group and 65 in the control group. Among them, 3 patients in the vNOTES group and 2 patients in the control group dropped out during the 3 months of follow-up due to incorrect phone numbers. Moreover, 1 patient in the vNOTES group was dropped out during the 6 months of follow-up, because she did not have sexual activity in the last month and refused to complete the questionnaire. Finally, 61 patients in the vNOTES group and 63 patients in the control group were followed up (Fig.
Subject screening and completion flowchart
FSFI score of patients in control group pre- and post-operationThe average age of included patients was 31.70 ± 5.02 and 30.37 ± 5.74 years old in the vNOTES group and control group respectively, and there was no statistically significant difference between the two groups (P = 0.413). The average body mass index (BMI) of patients in the vNOTES group and control group was 21.76 ± 3.16 Kg/m2 and 23.30 ± 2.69 Kg/m2 respectively, with no significant difference between the two groups (P = 0.077). The preoperative FSFI score of patients in the vNOTES group and control group was 22.31 ± 2.25 and 21.55 ± 3.38 respectively, with no statistically significant difference (P = 0.143). There was no statistically significant difference between the two groups in terms of education level and surgical type (Table The total FSFI score of patients in the vNOTES group before surgery, 3 months after surgery, and 6 months after surgery was 22.31 ± 2.25, 22.06 ± 3.07, and 21.61 ± 3.22 respectively. There was no statistically significant difference in the total score of FSFI at 3 months and 6 months after surgery compared with the total score of FSFI before surgery (P = 0.085) (Table The total FSFI score of patients in the control group before surgery, 3 months after surgery, and 6 months after surgery was 21.55 ± 3.38, 21.00 ± 2.95, and 20.99 ± 3.26 respectively. There was no statistically significant difference in the total score of FSFI at 3 months and 6 months after surgery compared with the total score of FSFI before surgery (P = 0.228) (Table Compared with that in the control group, the total score of FSFI in the vNOTES group had no statistical difference at 3 months and 6 months after surgery. The time to start sexual life after surgery in the vNOTES group and control group was 39.34 ± 0.71 days and 37.86 ± 0.69 days respectively, with a significant difference (P = 0.001) (Table
Comparison between vNOTES group and control group postoperation | PMC10398902 | ||
Discussion | sexual pain, vaginal innervation | VAGINA | This study was designed to assess the effect of vNOTES on female sexual function. Our results revealed no significant difference in sexual function before and after surgery in patients undergoing vNOTES, and also no significant difference in sexual function after surgery between patients receiving vNOTES and transabdominal laparoscopy. However, the time of starting sexual life after vNOTES is later than that after transabdominal laparoscopy.vNOTES is a novel surgical approach emerging in recent years. Gettman MT et al. [The current studies relevant to vNOTES have reported its feasibility and effectiveness, but its long-term safety and impact on the quality of life of patients have not been deeply discussed. This study used the validated FSFI questionnaire to evaluate six dimensions of sexual function (sexual desire, arousal, vaginal lubrication, orgasm, satisfaction, and sexual pain) and found that there was no significant difference in sexual function before and after surgery in the vNOTES group. This may be related to the anatomical structure and nerve distribution of the female lower genital tract. The vaginal innervation is concentrated to the far and front along the vaginal wall, leaving sparse sensory innervation of the posterior fornix, while the incision of vNOTES is just located at the posterior fornix of the vagina, so it has little impact on it [There is currently no randomized controlled study on the optimal time to start sexual life after vNOTES. According to previous studies, the suggested time of starting sexual life is 2 weeks after surgery [However, this study has a limitation. We only assessed changes in women’s sexual function after surgery. The sexual life is mutual, and male sexual satisfaction should also be valued. For example, the Arizona sexual experiences scale (ASEX) can be used to assess the sexual function of both partners. Therefore, in the future more large sample randomized controlled studies are needed to further evaluate the impact of vNOTES on the sexual satisfaction of both sexual partner. | PMC10398902 |
Acknowledgements | Not applicable. | PMC10398902 | ||
Authors’ contributions | GZL | XDY: study concept, data verification, literature review, manuscript writing, and manuscript revision. HL (Lu Huang): study concept, data verification, literature review, manuscript writing, and manuscript revision. HL (Li He): data verification, literature review, and manuscript writing. LYH: preparation of data for statistical analysis, manuscript writing, and approval of statistical results and outcomes. ZYY, ZQ: manuscript revision, literature review, and data verification for revised manuscript. GZL, HQN: preparation and verification of data for statistical analysis, manuscript revision, and final approval of the manuscript. | PMC10398902 | |
Funding | This work was supported by grants from Technological Innovation Research and Development Project of Chengdu Science and Technology Management (2021-YF05-00627-SN), the Medical Research Foundation of Chengdu Health Commission (NO. 2021215), and the Chengdu High-level Key Clinical Specialty Construction Project. | PMC10398902 | ||
Data Availability | The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy restricions. | PMC10398902 | ||
Declarations | PMC10398902 | |||
Ethics approval and consent to participate | This study was approved by the Ethics Committee of Chengdu Women’s and Children’s Central Hospital (No: [2020]164). All participants provided written informed consent after enrollment. All methods were carried out in accordance with relevant institutional guidelines and regulations. | PMC10398902 | ||
Consent for publication | Not applicable. | PMC10398902 | ||
Competing interests | The authors declare no competing interests. | PMC10398902 |
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