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PACT Programme for Parents of Children With SHCN

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Gastrointestinal Diseases
Neurodevelopmental Disorders
Cleft Lip and Palate
Developmental Delay
Vascular Diseases
Urologic Diseases

Treatments

Behavioral: Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice
Behavioral: Positive parenting advice

Study type

Interventional

Funder types

Other

Identifiers

NCT05467527
2191269

Details and patient eligibility

About

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

Full description

Background: The caregiving burden experienced by parents of children with special health care needs (SHCN) is known to be significant, and its impact tends to be exacerbated when an outbreak of a novel infectious disease occurs. As shown in this coronavirus (COVID-19) pandemic, with the prolonged disruptions of individualised rehabilitation/supporting services which cannot be substituted by digital/remoted format and the unprecedented economic hardship, many parents of children with SHCN are under psychological distress, affecting parenting behaviours and child well-being. Existing interventions in literature only serve for suspected/infected cases/healthcare workers. Many interventions were developed without a conceptual understanding of what/how the proposed active/therapeutic ingredient(s)/process(es) could lead to desired outcomes. This study informs the development of a conceptual model, showing that two psychological constructs, namely psychological flexibility (a therapeutic process measured in Acceptance and Commitment Therapy) and prosociality (an attitude and/or behaviour that orient(s) toward the welfare of others and society) played significant roles in mitigating the adverse impact of COVID-19 on parental mental health.

Objectives: To determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence of parents and family functioning parents of children with SHCN as well as the mental well-being of parent-child dyads over 12 months follow-up.

Hypotheses to be tested: When compared to the Control Group, the participation in the PACT programme could improve parental mental well-being, child mental well-being, parental psychological flexibility and parental prosociality, parenting competence and family functioning at immediate, 3-, 6- and 12 months after the completion of the programme.

Design and subjects: A randomised controlled trial with a blinded, two-arm, repeated-measures design; 196 Cantonese-speaking parents/caregivers of children with special health care needs.

Study Instruments: Validated questionnaires.

Intervention: A 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice.

Primary outcome measure: Parental mental well-being and child mental well-being.

Data analysis: Generalised estimating equation specifying an identity link function and a normal distribution will be employed to examine its change across two groups and all assessment time-points, followed by posthoc comparisons.

Expected results: To increase the mental well-being of parents and their children with special health needs. In addition, parenting competence and family functioning will also be improved.

Enrollment

196 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cantonese-speaking Hong Kong residents
  • Living together with the child who is at preschool/school-age (3-8 years old)
  • Caregivers who adopted the responsibility of taking care of the child,
  • has daily access to their iPhone and Android smartphones.

In addition, potential eligible parents who respond "yes" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https://www.childhealthdata.org/docs/cshcn/technical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental/emotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.

Exclusion criteria

  • Parents who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

196 participants in 2 patient groups, including a placebo group

PACT Group
Experimental group
Description:
A combination of 6 online modules and 4 group-based video conferencing sessions of Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice via a mobile app across 12 weeks
Treatment:
Behavioral: Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice
Control Group
Placebo Comparator group
Description:
A combination of 6 online modules and 4 group-based video conferencing sessions of daily parenting challenges in caring for a child with SHCN plus positive parenting advice via a mobile app across 12 weeks
Treatment:
Behavioral: Positive parenting advice

Trial contacts and locations

2

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Central trial contact

Yuen Yu Chong, PhD; Wing Suet Hung

Data sourced from clinicaltrials.gov

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