ACT Combined Yoga for Parental Burnout in Parents with Autistic Children

February 11, 2025 updated by: Jiayi Chen, Harbin Medical University

ACT (Acceptance Commitment Therapy) Combined with Yoga for Parental Burnout in Parents with Autistic Children: a Randomized Controlled Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will focus on parents of children with ASD, and through literature review, intervention research, qualitative research, and other methods, based on PRO, adopt acceptance commitment therapy as the core intervention program to explore the improvement of parenting burnout, stress level and quality of life of parents, to enhance the psychological flexibility of parents with ASD, so that parents can positively cope with negative emotions and adverse events in life, and to promote the physical and mental health of parents and the quality of child care, so as to enhance the well-being and quality of life of families with ASD, and to enhance the well-being and quality of life of families with ASD. The program promotes the physical and mental health of parents and the quality of care for their children, thereby enhancing the well-being and quality of life of families with ASD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • None Selected
      • Daqing, None Selected, China, 043300
        • Recruiting
        • Harbin Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT-Y
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
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.
Active Comparator: Mental Health Education Group
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
The control group was provided with 8 weeks of mental health education, including emotional management skills, positive coping styles, and scientific parenting methods.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measuring parental Burnout Levels
Time Frame: 3 months
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
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57
Time Frame: 3 months
VIII. Patient Self-Report PROMIS-57 This 57-item scale includes seven subscales on physical functioning (1-8 items), anxiety (9-16 items), depression (17-24 items), fatigue (25-32 items), sleep status (33-40 items), ability to assume social roles and participate in social activities (41-48 items), and the effects of pain (49-57 items).
3 months
Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36
Time Frame: 3 months
The scale, revised by Sun Yat-sen Medical University, is an internationally recognized universal quality of life evaluation scale with high reliability and validity. The scale has a total of 36 items, which are divided into 8 dimensions of quality of life, including physiological function, physiological function, physical pain, general health, vitality, social function, emotional function, and mental health.
3 months
Acceptance and Action Questionnaire-II, AAQ-II
Time Frame: 3 months
The scale consists of 7 entries with a total score of 7-49, and the scores are summed so that the higher the score, the higher the level of empirical avoidance.
3 months
Cognitive Fusion Questionnaire，CFQ-F
Time Frame: 3 months
Contains 9 entries with a total score of 9-63; the higher the total CFQ-F score, the higher the level of cognitive integration.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Quanzhi Zhang, Doctor, Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMUDQ20240318001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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