"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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jojo Yan Yan Kwok, PhD
- Numéro de téléphone: 852 3917 6644
- E-mail: jojoyyk@hku.hk
Sauvegarde des contacts de l'étude
- Nom: Tsz Ying Christine Ng, MSc
- Numéro de téléphone: 852 6200 0023
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Aucune intervention: Waitlist control
Control group will undergo intervention after completing all assessments |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parenting stress
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parental distress
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
Walsh Family Resilience Scale (WFRS) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Family functioning
Délai: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
McMaster Family Assessment Device (FAD) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Intervention acceptability
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EA260737
- RG2026/2027_A_16 (Autre subvention/numéro de financement: Alice Ho Miu Ling Nethersole Charity Foundation)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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