Clinical trial NCT05872737: FAB Programme for Parents of Children With NDD
Official title: Facilitator-guided Acceptance and Commitment Bibliotherapy for Parents of Young Children With Neurodevelopmental Disorders: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Sheng Kung Hui Welfare Council Limited
First posted: 2023-05-24
Enrollment: 154
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, two-arm randomised controlled trial (RCT) with a repeated-measures parallel-group design
Primary purpose: TREATMENT

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.

Detailed description: Background: Neurodevelopmental disorders (NDDs) are heterogeneous disorders that typically develop in early childhood and are characterised by developmental deficits that result in impaired personal, social, and/or occupational functioning. In Hong Kong, according to the latest statistical report from the Education Bureau, it is estimated that at least 71,320 preschool and school-age children have been diagnosed with NDD and are currently receiving special education and/or health care services. It is well documented that NDD children have less clear communication signals to their parents and poorer prosocial skills.

Continued failures and difficulties in understanding and responding to children's needs may prevent parents from developing positive parenting behaviours, which can negatively impact parents' psychology and ultimately snowballing their NDD child's emotional and behavioural symptoms. To our knowledge, effective interventions that specifically target the mental health of parents caring for young children with NDD to improve outcomes for both parents and children are extremely scarce. To address this study gap, this study will implement and examine the effectiveness of the Facilitator-guided Acceptance and Commitment Bibliotherapy, a facilitator-guided manual reading psychotherapy approach that explicitly targets the psychological needs of parents, in parents of young children with NDD in On-site Pre-school Rehabilitation Service (OPRS) teams.

Objectives: To examine the effectiveness of the Facilitator-guided Acceptance and Commitment Bibliotherapy (FAB) and general parenting advice, in comparison to the control (general parenting advice only), on outcomes related to parental psychological health (parenting stress, symptoms of depression and anxiety, psychological flexibility), parenting behaviour, as well as the child's emotional and behavioural symptoms over 6 months of post-intervention period.

Hypotheses to be tested: Compared to the control group alone, FAB participation could achieve the following goals: reduce parents' parenting stress and NDD children's emotional and behavioural symptoms, reduce parental depressive and anxiety symptoms, improve psychological flexibility and nurturing behaviours of mindful parenting, and reduce the use of health care and rehabilitation services for young children with NDD over 6 months of post-intervention period.

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

Subjects: 154 Cantonese-speaking parents of children aged 2-6 years diagnosed with neurodevelopmental disorders

Instruments: Validated questionnaires

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

Main outcome measures: parental psychological health outcomes and the child's emotional and behavioural symptoms

Data analysis: Generalised estimating equation analyses with covariates adjustments

Expected results: After participating in FAB, parents will become more psychologically flexible in caring for their children with NDD. Parents also acquire better psychological health and mindful parenting skills, leading to eventful improvements in parent-child dyads health outcomes.

Eligibility criteria: 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).

Primary outcomes:
measure: Parenting stress
timeFrame: Change from baseline assessment to immediate and 6 months post-intervention
measure: Child's emotional and behavioural symptoms
timeFrame: Change from baseline assessment to immediate and 6 months post-intervention
Secondary outcomes:
measure: Parental symptoms of anxiety and depression
timeFrame: Change from baseline assessment to immediate and 6 months post-intervention
measure: Parental psychological flexibility
timeFrame: Change from baseline assessment to immediate and 6 months post-intervention
measure: Parenting behaviour
timeFrame: Change from baseline assessment to immediate and 6 months post-intervention
measure: Child's use of health care and rehabilitation services
timeFrame: Change from baseline assessment to immediate and 6 months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sheng Kung Hui Welfare Council Limited
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: