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

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?

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 Overview

• Status: Not yet recruiting
• Conditions: Autism
• Intervention / Treatment: Behavioral: Family Resilience And Mind-body Enhancement" (FRAME)

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jojo Yan Yan Kwok, PhD; Phone Number: 852 3917 6644; Email: jojoyyk@hku.hk
• Study Contact Backup: Name: Tsz Ying Christine Ng, MSc; Phone Number: 852 6200 0023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Resilience And Mind-body Enhancement" (FRAME)	Behavioral: 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.
No Intervention: Waitlist control; Control group will undergo intervention after completing all assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting stress	Parenting Stress Index - Short Form (PSI-SF)	From baseline (T0) to the end of treatment at 6 weeks (T1)
Parenting stress	Parenting Stress Index - Short Form (PSI-SF)	From baseline (T0) to the end of treatment at 18 weeks (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental distress	21-item Depression Anxiety Stress Scale-21 (DASS-21)	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parental Well-being	5-item World Health Organization Well-Being Index (WHO-5)	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Mindful parenting	31-item Interpersonal Mindfulness in Parenting Scale (IM-P)	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Child emotional and behavioural and problems	Parent and teacher-report Strengths and Difficulties Questionnaire (SDQ)	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)	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	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parent-child relationship	Parent-child dysfunctional interaction subscale of PSI-SF	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Marital satisfaction	3-item Kansas Marital Satisfaction Scale (KMS)	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family resilience	Walsh Family Resilience Scale (WFRS)	Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family functioning	McMaster Family Assessment Device (FAD)	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.	Assessed at T1 (immediately post-intervention)

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 12, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; autism; parenting; mind-body; families; family resilience
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder
• Other Study ID Numbers: EA260737; RG2026/2027_A_16 (Other Grant/Funding Number: Alice Ho Miu Ling Nethersole Charity Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No