"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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jojo Yan Yan Kwok, PhD
- Telefonnummer: 852 3917 6644
- E-post: jojoyyk@hku.hk
Studera Kontakt Backup
- Namn: Tsz Ying Christine Ng, MSc
- Telefonnummer: 852 6200 0023
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: Waitlist control
Control group will undergo intervention after completing all assessments |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Parenting stress
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Parental distress
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
Walsh Family Resilience Scale (WFRS) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Family functioning
Tidsram: Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
McMaster Family Assessment Device (FAD) |
Baseline (T0), 6 weeks (T1), 18 weeks (T2)
|
|
Intervention acceptability
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EA260737
- RG2026/2027_A_16 (Annat bidrag/finansieringsnummer: Alice Ho Miu Ling Nethersole Charity Foundation)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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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