NCT06348992

Brief Summary

OBJECTIVE: To explore the intervention effect of ACT combined with a yoga intervention program on parenting burnout in parents with ASD. METHODS: This study used a combination of qualitative research and quantitative analysis to examine the intervention effects of an ACT-centered intervention program on parenting burnout in parents of children with ASD, and to clarify the evaluations and perceptions of parents with ASD about the research program through qualitative research. RESULTS AND CONCLUSION: To clarify the intervention effect of ACT combined with yoga intervention program on parenting burnout of ASD parents.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

March 20, 2024

Last Update Submit

February 11, 2025

Conditions

Keywords

Autism spectrum disorderParental burnoutAcceptance commitment therapyYogaPsychosomatic intervention

Outcome Measures

Primary Outcomes (2)

  • Measuring parental Burnout Levels

    Developed by Roskam et al. to assess parenting burnout levels. There are 23 items in the scale, which are divided into four dimensions: the sense of exhaustion of the parental role, the boredom of the parental role, the emotional alienation from the children, and the self-comparison with the previous parental role. Scores range from 23-161. Higher scores indicate higher levels of parental burnout.

    3 months

  • Measuring parenting stress Levels

    The scale consists of 15 items divided into three dimensions: parenting distress (items 1-5), dysfunctional parent-child interactions (items 6-10), and difficult child characteristics (items 11-15). The total score ranges from 15 to 75, with higher scores indicating more severe parenting stress.

    3 months

Secondary Outcomes (4)

  • Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57

    3 months

  • Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36

    3 months

  • Acceptance and Action Questionnaire-II, AAQ-II

    3 months

  • Cognitive Fusion Questionnaire,CFQ-F

    3 months

Study Arms (2)

ACT-Y

EXPERIMENTAL

Based on ACT and supplemented by Hatha Yoga exercise intervention, the intervention group used a combination of offline ACT psychological intervention and online Hatha Yoga training. ACT-Y intervention will be based on ACT combined with Yoga training and comprises a programme divided into eight 1-hour sessions conducted over 8 weeks

Behavioral: Acceptance commitment therapy and yoga

Mental Health Education Group

ACTIVE COMPARATOR

The control group also received 8 weeks of mental health education, including stress coping strategies, scientific parenting knowledge, and emotional management skills.

Behavioral: Active Comparator: Mental Health Education Group

Interventions

The intervention used a combination of online and offline methods, based on ACT, supplemented by hatha yoga exercise intervention, the intervention group used the combination of offline ACT psychological intervention and online hatha yoga training, and the control group used mental health education, so as to explore and validate the effect of ACT combined with yoga on the improvement of parental parental burnout in children with ASD. The offline ACT psychological intervention was implemented by the researchers and psychologists, and the ACT psychological intervention was carried out once a week in community health centers or hospitals for 8 weeks. Online, a WeChat group was set up for parents with ASD, and Hatha Yoga training content and videos were sent to the group chat, and the researchers and volunteers supervised the training and clocking in and out of the group, three times a week.

ACT-Y

The control group was provided with 8 weeks of mental health education, including emotional management skills, positive coping styles, and scientific parenting methods.

Mental Health Education Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of children diagnosed with ASD based on DSM-5
  • Parental burnout exists in parents
  • Parents have normal speech, hearing and cognitive functioning
  • Is the primary caregiver for children
  • Informed consent and voluntary participation

You may not qualify if:

  • Untreated ongoing or severe psychiatric disorders such as anxiety disorders, depressive disorders, schizophrenia, etc.;
  • other more serious psychosomatic disorders that would interfere with the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University Hospital

Daqing, None Selected, 043300, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Acceptance and Commitment TherapyYoga

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Quanzhi Zhang, Doctor

    Harbin Medical University

    STUDY CHAIR

Central Study Contacts

Jiayi Chen, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 5, 2024

Study Start

September 1, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations