Autism Spectrum DisorderNCT06348992
ACT Combined Yoga for Parental Burnout in Parents with Autistic Children
A study testing Acceptance commitment therapy and yoga and Active Comparator: Mental Health Education Group in people with Autism Spectrum Disorder, run by Harbin Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Acceptance commitment therapy and yoga and Active Comparator: Mental Health Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Harbin Medical University Hospital
Daqing, None Selected, 043300
Jiayi Chen, Master, 15765962070, cjy071949@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Acceptance commitment therapy and yoga, Active Comparator: Mental Health Education Group
- Keywords
- Autism spectrum disorder, Parental burnout, Acceptance commitment therapy, Yoga, Psychosomatic intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance commitment therapy and yogaBehavioural
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 GroupBehavioural
The control group was provided with 8 weeks of mental health education, including emotional management skills, positive coping styles, and scientific parenting methods.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Active Comparator: Mental Health Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57
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).
Measured: 3 months
Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36
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.
Measured: 3 months
Acceptance and Action Questionnaire-II, AAQ-II
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.
Measured: 3 months
Cognitive Fusion Questionnaire，CFQ-F
Contains 9 entries with a total score of 9-63; the higher the total CFQ-F score, the higher the level of cognitive integration.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Sep 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayi Chen, Harbin Medical University
- Investigators
- Quanzhi Zhang, Doctor, Study chair, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348992
- Sponsor's protocol ID
- HMUDQ20240318001
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT (Acceptance Commitment Therapy) Combined with Yoga for Parental Burnout in Parents with Autistic Children: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06348992
- Acronym / sponsor ID
- HMUDQ20240318001
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Parental burnout, Acceptance commitment therapy, Yoga, Psychosomatic intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-Y | Experimental | Behavioral: Acceptance commitment therapy and yogaBased 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 |
| Mental Health Education Group | Active comparator | Behavioral: Active Comparator: Mental Health Education GroupThe control group also received 8 weeks of mental health education, including stress coping strategies, scientific parenting knowledge, and emotional management skills. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance commitment therapy and yogaThe 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. | Behavioural | ACT-Y |
| Active Comparator: Mental Health Education GroupThe control group was provided with 8 weeks of mental health education, including emotional management skills, positive coping styles, and scientific parenting methods. | Behavioural | Mental Health Education Group |
Primary outcome
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.
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.
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System adult profile-57, PROMIS-57
Time frame: 3 months
Medical Outcomes Study 36-Item Short-Form Health Survey, MOS SF-36
Time frame: 3 months
Acceptance and Action Questionnaire-II, AAQ-II
Time frame: 3 months
Cognitive Fusion Questionnaire，CFQ-F
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quanzhi Zhang, Doctor study chair
Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance commitment therapy and yoga and Active Comparator: Mental Health Education Group in people with Autism Spectrum Disorder, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Chen, Master (15765962070, cjy071949@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring parental Burnout Levels (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.