"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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jojo Yan Yan Kwok, PhD
- Numero di telefono: 852 3917 6644
- Email: jojoyyk@hku.hk
Backup dei contatti dello studio
- Nome: Tsz Ying Christine Ng, MSc
- Numero di telefono: 852 6200 0023
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Nessun intervento: Waitlist control
Control group will undergo intervention after completing all assessments |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Parenting stress
Lasso di tempo: 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)
|
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Parenting stress
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Parental distress
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
Walsh Family Resilience Scale (WFRS) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Family functioning
Lasso di tempo: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
McMaster Family Assessment Device (FAD) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Intervention acceptability
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EA260737
- RG2026/2027_A_16 (Altro numero di sovvenzione/finanziamento: Alice Ho Miu Ling Nethersole Charity Foundation)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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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