Trials / Recruiting

RecruitingNCT05467527

PACT Programme for Parents of Children With SHCN

Effectiveness of Prosocial-orientated Acceptance and Commitment Training (PACT) Programme for Parents of Children With Special Health Care Needs in Response to Outbreaks of Novel Infectious Disease: A Randomised Controlled Trial

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 196 (estimated)

Sponsor: Chinese University of Hong Kong · Academic / Other
Sex: All
Age: 21 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice	The PACT group will receive 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. The modules will cover real-life scenarios of daily parenting challenges in caring for a child with SHCN, followed by age-appropriate positive parenting advice based on the Centers for Disease Control and Prevention guidelines. After going through the scenarios, parents will be audio/visually guided to participate in ACT activities, including mindfulness exercises, ACT metaphors and experiential exercises, which will be used to increase psychological flexibility.
BEHAVIORAL	Positive parenting advice	The Control Group will receive a total of 6 online modules and 4 group-based video conferencing sessions in a closed group of 6-8, 60 minutes per session guided by a trained facilitator via the mobile app across 12 weeks. The online modules will provide identical contents to those in the PACT group, but no guided ACT metaphors or experiential exercises. The interaction sessions serve to review and discuss the contents of online modules, but without the contents related to ACT/prosociality.

Timeline

Start date: 2022-06-27
Primary completion: 2025-11-30
Completion: 2025-12-31
First posted: 2022-07-20
Last updated: 2025-08-13

Locations

2 sites across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT05467527. Inclusion in this directory is not an endorsement.