AutismFRAMENCT07920380
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
A study testing Family Resilience And Mind-body Enhancement" (FRAME) in people with Autism, run by The University of Hong Kong.
Trial summary
The goal of this clinical trial is to learn if a family resilience and mind-body programme called "Family Resilience And Mind-body Enhancement" (FRAME) works to support families with autistic children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism
- What is being tested?
- Family Resilience And Mind-body Enhancement" (FRAME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2026to 31 Jul 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible if they:
- identify as the primary caregiver of at least one child aged 6-12 with an ASD diagnosis from a psychologist, pediatrician, or psychiatrist;
- currently cohabit with the child;
- provide informed consent to participate; and
- understand and can communicate in Cantonese Chinese
Who cannot join
- Individuals will be excluded if they
- have significant medical condition(s) rendering them incapable of participating in the study; or
- are currently receiving other therapist-led psychological intervention(s).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tsz Ying Christine Ng, MSc contact
About this study
Official title: Effects of "Family Resilience And Mind-body Enhancement" (FRAME) - a Mind-body Intervention for Parents With Autistic Children: A Randomised Controlled Trial
The goal of this clinical trial is to learn if a family resilience and mind-body programme called "Family Resilience And Mind-body Enhancement" (FRAME) works to support families with autistic children. The main question it aims to answer is:
- What are the effectiveness and acceptability of FRAME for families with autistic children?
Read more
Researchers will compare FRAME to a waitlist group (participants who receive the programme after the study ends) to see if FRAME makes a difference.
Participants will:
- Attend six weekly 2-hour group sessions, each combining mind-body practices and family resilience concepts
- Practise mindfulness exercises at home between sessions
- Complete questionnaires before and immediately after the programme, and 3 months later
- Conditions
- Autism
- Being tested
- Family Resilience And Mind-body Enhancement" (FRAME)
- Keywords
- autism, parenting, families, mind-body, family resilience, randomized controlled trial
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Resilience And Mind-body Enhancement" (FRAME)Behavioural
Family Resilience And Mind-body Enhancement (FRAME) is a parent-focused mind-body intervention designed for parents of autistic children. Across six weekly 2hr sessions, FRAME integrates mind-body practices - which have demonstrated efficacy among families with autistic children - with Walsh's three domains of family resilience, namely belief systems, organizational patterns and communication processes. The mind-body component will be adapted from MYmind - an established mindfulness-based intervention specifically developed for children with ASD/ADHD and their parents. Each session follows a standard format: a review on home practice, guided mind-body practices and structured group discussions and activities targeting each domain of family resilience. Session content progresses sequentially across the six sessions. Between sessions, participants are encouraged to practise daily using the workbook provided.
| Study group | Role | What they receive |
|---|---|---|
| Family Resilience And Mind-body Enhancement" (FRAME) | Experimental | Not described Receives: Behavioral: Family Resilience And Mind-body Enhancement" (FRAME) |
| Waitlist control | No intervention | Control group will undergo intervention after completing all assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting stress
Parenting Stress Index - Short Form (PSI-SF)
Measured: From baseline (T0) to the end of treatment at 6 weeks (T1)
Parenting stress
Parenting Stress Index - Short Form (PSI-SF)
Measured: From baseline (T0) to the end of treatment at 18 weeks (T2)
Secondary outcomes (11)
Parental distress
21-item Depression Anxiety Stress Scale-21 (DASS-21)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parental Well-being
5-item World Health Organization Well-Being Index (WHO-5)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Mindful parenting
31-item Interpersonal Mindfulness in Parenting Scale (IM-P)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Child emotional and behavioural and problems
Parent and teacher-report Strengths and Difficulties Questionnaire (SDQ)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Sibling emotional and behavioural problems (only for families with more than one child)
Parent-report Strengths and Difficulties Questionnaire (SDQ)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parent-sibling relationship (only for families with more than one child)
Parent-report parent-child dysfunctional interaction subscale of PSI-SF
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parent-child relationship
Parent-child dysfunctional interaction subscale of PSI-SF
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Marital satisfaction
3-item Kansas Marital Satisfaction Scale (KMS)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family resilience
Walsh Family Resilience Scale (WFRS)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family functioning
McMaster Family Assessment Device (FAD)
Measured: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Intervention acceptability
A 4-item self-reported program evaluation measured on a 10-point scale, assessing: (a) easiness of the program contents, (b) usefulness of the treatment, (c) overall satisfaction, and (d) likelihood to recommend the treatment to others. Higher scores indicate greater acceptability.
Measured: Assessed at T1 (immediately post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start12 Nov 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok Yan Yan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920380
- Sponsor's protocol ID
- EA260737
- Other IDs
- RG2026/2027_A_16
- Acronym
- FRAME
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting the findings of this study are available upon request from the principal investigator, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of "Family Resilience And Mind-body Enhancement" (FRAME) - a Mind-body Intervention for Parents With Autistic Children: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07920380
- Acronym / sponsor ID
- FRAME / EA260737
- Conditions
- Autism
- Keywords
- autism, parenting, families, mind-body, family resilience, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
The goal of this clinical trial is to learn if a family resilience and mind-body programme called "Family Resilience And Mind-body Enhancement" (FRAME) works to support families with autistic children. The main question it aims to answer is:
- What are the effectiveness and acceptability of FRAME for families with autistic children?
Researchers will compare FRAME to a waitlist group (participants who receive the programme after the study ends) to see if FRAME makes a difference.
Participants will:
- Attend six weekly 2-hour group sessions, each combining mind-body practices and family resilience concepts
- Practise mindfulness exercises at home between sessions
- Complete questionnaires before and immediately after the programme, and 3 months later
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Resilience And Mind-body Enhancement" (FRAME) | Experimental | Behavioral: Family Resilience And Mind-body Enhancement" (FRAME) |
| Waitlist control | No intervention | –Control group will undergo intervention after completing all assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- identify as the primary caregiver of at least one child aged 6-12 with an ASD diagnosis from a psychologist, pediatrician, or psychiatrist;
- currently cohabit with the child;
- provide informed consent to participate; and
- understand and can communicate in Cantonese Chinese
Key exclusion criteria (3 listed)
- Individuals will be excluded if they
- have significant medical condition(s) rendering them incapable of participating in the study; or
- are currently receiving other therapist-led psychological intervention(s).
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 |
|---|---|---|
| Family Resilience And Mind-body Enhancement" (FRAME)Family Resilience And Mind-body Enhancement (FRAME) is a parent-focused mind-body intervention designed for parents of autistic children. Across six weekly 2hr sessions, FRAME integrates mind-body practices - which have demonstrated efficacy among families with autistic children - with Walsh's three domains of family resilience, namely belief systems, organizational patterns and communication processes. The mind-body component will be adapted from MYmind - an established mindfulness-based intervention specifically developed for children with ASD/ADHD and their parents. Each session follows a standard format: a review on home practice, guided mind-body practices and structured group discussions and activities targeting each domain of family resilience. Session content progresses sequentially across the six sessions. Between sessions, participants are encouraged to practise daily using the workbook provided. | Behavioural | Family Resilience And Mind-body Enhancement" (FRAME) |
Primary outcome
Parenting stress
Time frame: From baseline (T0) to the end of treatment at 6 weeks (T1)
Parenting Stress Index - Short Form (PSI-SF)
Parenting stress
Time frame: From baseline (T0) to the end of treatment at 18 weeks (T2)
Parenting Stress Index - Short Form (PSI-SF)
11 secondary outcomes
Parental distress
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parental Well-being
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Mindful parenting
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Child emotional and behavioural and problems
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Sibling emotional and behavioural problems (only for families with more than one child)
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parent-sibling relationship (only for families with more than one child)
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parent-child relationship
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Marital satisfaction
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family resilience
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family functioning
Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Intervention acceptability
Time frame: Assessed at T1 (immediately post-intervention)
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 5 Nov 2026.
- Individual participant dataSharing planned: No. The data supporting the findings of this study are available upon request from the principal investigator, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
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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.
Tsz Ying Christine Ng, MSc contact
Questions about this trial
What is this clinical trial studying?
A study testing Family Resilience And Mind-body Enhancement" (FRAME) in people with Autism, run by The University of Hong Kong.
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 3 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jojo Yan Yan Kwok, PhD (852 3917 6644, jojoyyk@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting stress (time frame: From baseline (T0) to the end of treatment at 6 weeks (T1)). 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 5 Nov 2026.