"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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jojo Yan Yan Kwok, PhD
- 전화번호: 852 3917 6644
- 이메일: jojoyyk@hku.hk
연구 연락처 백업
- 이름: Tsz Ying Christine Ng, MSc
- 전화번호: 852 6200 0023
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: Waitlist control
Control group will undergo intervention after completing all assessments |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parenting stress
기간: From baseline (T0) to the end of treatment at 6 weeks (T1)
|
Parenting Stress Index - Short Form (PSI-SF) |
From baseline (T0) to the end of treatment at 6 weeks (T1)
|
|
Parenting stress
기간: From baseline (T0) to the end of treatment at 18 weeks (T2)
|
Parenting Stress Index - Short Form (PSI-SF) |
From baseline (T0) to the end of treatment at 18 weeks (T2)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parental distress
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
21-item Depression Anxiety Stress Scale-21 (DASS-21) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Parental Well-being
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
5-item World Health Organization Well-Being Index (WHO-5) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Mindful parenting
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
31-item Interpersonal Mindfulness in Parenting Scale (IM-P) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Child emotional and behavioural and problems
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
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)
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
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)
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
Parent-report parent-child dysfunctional interaction subscale of PSI-SF |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Parent-child relationship
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
Parent-child dysfunctional interaction subscale of PSI-SF |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Marital satisfaction
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
3-item Kansas Marital Satisfaction Scale (KMS) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Family resilience
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
Walsh Family Resilience Scale (WFRS) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Family functioning
기간: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
McMaster Family Assessment Device (FAD) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Intervention acceptability
기간: 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. Higher scores indicate greater acceptability. |
Assessed at T1 (immediately post-intervention)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- EA260737
- RG2026/2027_A_16 (기타 보조금/기금 번호: Alice Ho Miu Ling Nethersole Charity Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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