ClinicalTrials.gg
Not yet recruitingNCT07920380FRAMEUpdated Nov 5, 2026

"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial

An interventional study of Family Resilience And Mind-body Enhancement" (FRAME) in Autism, sponsored by The University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Autism

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Keywords

  • autism
  • parenting
  • families
  • mind-body
  • family resilience
  • randomized controlled trial
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 114 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 to participate; and
  • understand and can communicate in Cantonese Chinese

Exclusion criteria

Exclusion Criteria:

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
114 participants (estimated)

Study arms

  • Experimental
    Family Resilience And Mind-body Enhancement" (FRAME)

    Behavioral: Family Resilience And Mind-body Enhancement" (FRAME)

  • No intervention
    Waitlist control

    Control group will undergo intervention after completing all assessments

Interventions

  • BehavioralFamily 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.

06

What researchers measure

Primary outcomes

  1. Parenting stress

    Parenting Stress Index - Short Form (PSI-SF)

    Time frame: From baseline (T0) to the end of treatment at 6 weeks (T1)

  2. Parenting stress

    Parenting Stress Index - Short Form (PSI-SF)

    Time frame: From baseline (T0) to the end of treatment at 18 weeks (T2)

Secondary outcomes

  1. Parental distress

    21-item Depression Anxiety Stress Scale-21 (DASS-21)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  2. Parental Well-being

    5-item World Health Organization Well-Being Index (WHO-5)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  3. Mindful parenting

    31-item Interpersonal Mindfulness in Parenting Scale (IM-P)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  4. Child emotional and behavioural and problems

    Parent and teacher-report Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  5. Sibling emotional and behavioural problems (only for families with more than one child)

    Parent-report Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  6. Parent-sibling relationship (only for families with more than one child)

    Parent-report parent-child dysfunctional interaction subscale of PSI-SF

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  7. Parent-child relationship

    Parent-child dysfunctional interaction subscale of PSI-SF

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  8. Marital satisfaction

    3-item Kansas Marital Satisfaction Scale (KMS)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  9. Family resilience

    Walsh Family Resilience Scale (WFRS)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  10. Family functioning

    McMaster Family Assessment Device (FAD)

    Time frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

  11. 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.

    Time frame: Assessed at T1 (immediately post-intervention)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07920380
Responsible party
Kwok Yan Yan (Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 12, 2026 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Jojo Yan Yan Kwok, PhD
Contact
jojoyyk@hku.hk
852 3917 6644
Tsz Ying Christine Ng, MSc
Contact
852 6200 0023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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