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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...
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 ...
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 th...
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 th...
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...
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 par...
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 ch...
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...
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-u...
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 basel...
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 Stati...
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...
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-in...
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 ...
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 ...
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 fathe...
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(-...
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 effec...
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 ...
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 autist...
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, stigma...
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 ...
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, i...
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 autisti...
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 e...
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, sta...
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 ve...
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 fu...
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 o...
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 pathologica...
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-s...
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 cy...
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 estim...
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 droppe...
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 transabdom...
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 s...
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