FAB Programme for Parents of Children With NDD

NCT05872737 | Recruiting DMC

• 1 other identifier: NTEC-2022-0091
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to examine the effectiveness of a psychotherapy approach called Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) in improving the psychological health of parents of young children with neurodevelopmental disorders (NDD) and reducing the emotional and behavioral symptoms of NDD children. The study will involve 154 Cantonese-speaking parents of children aged 2-6 years diagnosed with NDD in Hong Kong. The study hopes to find that FAB can improve parent-child dyads' health outcomes by enhancing psychological flexibility, parental psychological health, and mindful parenting skills.

Conditions

Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders; Intellectual Disability; Specific Learning Disorder; Communication Disorders; Motor Disorders

Keywords

Neurodevelopmental disorders; Facilitator-guided Acceptance and Commitment Bibliotherapy; Parental psychological health; Parenting stress; Repeated-measures parallel-group design; Randomized controlled trial; Psychological flexibility; Hong Kong; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (2)

• Parenting stress

  The Parenting Stress Index-Short Form (PSI-SF, 36 items, 5-point Likert scale). The PSI-SF evaluates parenting stress in three dimensions: parental distress, parent-child dysfunctional interaction, and difficult child behaviour (12 items each), with all items summed to indicate the total parenting stress \[48\]. Parents are asked to rate how much they agree or disagree with each statement using a 5-point Likert scale, ranging from "strongly agree" to "strongly disagree". Higher scores indicate higher levels of parenting stress. The Chinese version of PSI-SF (and its subscales) demonstrated strong convergent validity, discriminant validity and internal consistency (α =.79-.88) in Chinese parents.

  Change from baseline assessment to immediate and 6 months post-intervention

• Child's emotional and behavioural symptoms

  The Strengths and Difficulties Questionnaire (SDQ, 25 items, 3-point Likert scale). The SDQ consists of 25 items that assess five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is rated on a 3-point Likert scale, with higher scores indicating greater symptom severity for the emotional and behavioral problem domains and greater prosocial behavior for the prosocial behavior domain. The Chinese version of SDQ reported adequate test-retest reliabilities (ICC=.75-.86) and discriminant validity in Hong Kong parents.

  Change from baseline assessment to immediate and 6 months post-intervention

Secondary Outcomes (4)

• Parental symptoms of anxiety and depression

  Change from baseline assessment to immediate and 6 months post-intervention

• Parental psychological flexibility

  Change from baseline assessment to immediate and 6 months post-intervention

• Parenting behaviour

  Change from baseline assessment to immediate and 6 months post-intervention

• Child's use of health care and rehabilitation services

  Change from baseline assessment to immediate and 6 months post-intervention

Study Arms (2)

Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB)

EXPERIMENTAL

A 12-week facilitator-guided Acceptance and Commitment Bibliotherapy, which includes general parenting advice and is delivered via a website

Behavioral: Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB)

Control Group

PLACEBO COMPARATOR

Routine family support services and four video-conferencing sessions over the course of 12 weeks

Behavioral: General Parenting Education and Advice

Interventions

Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) BEHAVIORAL

The Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) is a 12-week self-help parenting program that integrates Acceptance and Commitment Therapy (ACT) principles with web-based modules and group-based sessions. The program includes a self-help workbook/manual and ACT protocols that cover various self-help exercises such as guided imagery, grounding, mindfulness, and values clarifications. To make the programme more relatable to Hong Kong parents caring for children with NDD, storytelling vignettes and therapeutic narratives will be included. Parents will work on each module at their own pace within 2-3 weeks and meet with trained facilitators in a video-conferencing format after completing each module to review their progress and learn positive parenting techniques.

Also known as: FAB

Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB)

General Parenting Education and Advice BEHAVIORAL

Both the FAB group and the Control Group will receive routine family support services from collaborating NGOs, including education on managing the emotional and behavioral symptoms of children with NDD. To control for the interaction/social effect present in the FAB group, the Control Group will also receive four video-conferencing sessions guided by a trained research assistant over 12 weeks. These sessions will facilitate parents to discuss their parenting challenges, identify parenting traps, and provide general parenting advice as recommended by the Child Assessment Services, Department of Health under the HKSAR government.

Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Parents of young children with NDD who fulfil the following criteria will be recruited: * Cantonese-speaking Hong Kong residents, * aged ≥ 21 years, * have a child aged between two and six years old (preschool age) with a clinically documented diagnosis/suspected NDD diagnosis according to DSM-5 criteria (e.g., ASD, ADHD, developmental delay) and enrolled in the SWD subvented pre-school rehabilitation services offered by NGOs, * caregivers who adopted the responsibility of taking care of the child, living together with the child, and * have device(s) with internet access. Parents of young children with NDD will be excluded if: * has been diagnosed with severe mental illness(es), * cognitive/language/communication/visual/hearing impairment(s) or disorders that may present difficulties in comprehending the content of the intervention; and/or * are currently receiving another psychosocial, psychoeducational, or parenting intervention(s).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Sheng Kung Hui Welfare Council Limited: collaborator

Study Sites (2)

Hong Kong Sheng Kung Hui Welfare Council Limited

Hong Kong, Hong Kong

RECRUITING

The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Intellectual Disability; Specific Learning Disorder; Communication Disorders; Motor Disorders

Interventions

Counseling

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Learning Disabilities

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Yuen Yu CHONG, PhD

CONTACT

(852) 3943 0665; conniechong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A multi-centre, two-arm randomised controlled trial (RCT) with a repeated-measures parallel-group design

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 24, 2023
• Study Start: June 5, 2023
• Primary Completion: September 8, 2025
• Study Completion (Estimated): September 8, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

HK (2)