Family Resilience And Mind-body Enhancement (FRAME) (FRAME)

November 6, 2026 updated by: Kwok Yan Yan, The University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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.
114

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.
  • 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

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

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

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: Single

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.
No Intervention: Waitlist control

Control group will undergo intervention after completing all assessments
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.

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

Parenting stress will be measured using Parenting Stress Index - Short Form (PSI-4-SF) 4th edition. Total score ranges from 36 to 180, with higher scores indicating greater parenting distress.
From baseline (T0) to the end of treatment at 6 weeks (T1)
Parenting stress
Time Frame: From baseline (T0) to the end of treatment at 18 weeks (T2)

Parenting stress will be measured using Parenting Stress Index - Short Form (PSI-4-SF) 4th edition. Total score ranges from 36 to 180, with higher scores indicating greater parenting distress.
From baseline (T0) to the end of treatment at 18 weeks (T2)

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
Parental distress
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using the Depression Anxiety Stress Scale-21 (DASS-21). Total score ranges from 0 to 63, with higher scores indicating greater distress.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parental Well-being
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using the World Health Organization Five Well-Being Index (WHO-5). The raw score ranges from 0 to 25. Higher scores indicate better well-being.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Mindful parenting
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured by the 23-item validated Chinese version of Interpersonal Mindfulness in Parenting Scale (IM-P). The total score ranges from 23 to 115. Higher scores indicate more mindfulness in parenting
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Child emotional and behavioural and problems
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using both parent- and teacher-report Strengths and Difficulties Questionnaire (SDQ). The total difficulties score ranges from 0 to 40. Higher scores indicate greater emotional and behavioural and problems.
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)

Measured using parent-report Strengths and Difficulties Questionnaire (SDQ). The total difficulties score ranges from 0 to 40. Higher scores indicate greater emotional and behavioural and problems.
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)

Measured using the Parent-Child Dysfunctional Interaction subscale of the PSI-4-SF. The subscale score ranges from 12 to 60. Higher scores indicate greater dysfunctional interaction and poorer relationship.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Parent-child relationship
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using the Parent-Child Dysfunctional Interaction subscale of the PSI-4-SF. The subscale score ranges from 12 to 60. Higher scores indicate greater dysfunctional interaction and poorer relationship.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Marital satisfaction (only for married parents)
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using the Kansas Marital Satisfaction Scale (KMS). The total score ranges from 3 to 21, with higher scores indicating greater marital satisfaction.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family resilience
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using the 26-item validated Chinese version of Walsh Family Resilience Questionnaire (WFRQ). The total score ranges from 26 to 130. Higher scores indicate greater family resilience.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Family functioning
Time Frame: Baseline (T0), 6 weeks (T1), 18 weeks (T2)

Measured using the 12-item General Functioning subscale of the McMaster Family Assessment Device (FAD). The total score ranges from 1 to 4, with scores calculated as the mean of the 12 items. Higher scores indicate worse family functioning.
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
Intervention acceptability
Time Frame: Assessed at T1 (immediately post-intervention)

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. Total scores range from 1 to 10, with higher scores indicating greater acceptability.
Assessed at T1 (immediately post-intervention)

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.
The University of Hong Kong

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 (Estimated)

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.
November 12, 2026

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.
July 31, 2028

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.
July 31, 2028

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).
October 30, 2026

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.
October 30, 2026

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.
November 5, 2026

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.
November 12, 2026

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.
November 6, 2026

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.
November 1, 2026

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.
  • 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

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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