Clinical trial NCT05467527: PACT Programme for Parents of Children With SHCN
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Diseases
Gastrointestinal Diseases
Vascular Diseases
Cleft Lip and Palate
Neurodevelopmental Disorders
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Developmental Delay
Keywords: Acceptance and Commitment Therapy
Randomised Controlled Trial
Special health care needs
novel infectious disease
prosociality
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Children's Hospital
name: Hong Kong Young Women's Christian Association
First posted: 2022-07-20
Enrollment: 196
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment; repeated-measures 2-arm randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental mental well-being
timeFrame: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
measure: Child mental well-being
timeFrame: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
Secondary outcomes:
measure: Parental psychological flexibility
timeFrame: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
measure: Parental prosociality
timeFrame: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
measure: Parenting competence
timeFrame: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
measure: Family functioning
timeFrame: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
Other outcomes:
Locations:
city: Ngau Tau Kok
country: Hong Kong
facility: Department of Surgery, Hong Kong Children's Hospital
state: Kowloon
city: Kowloon
country: Hong Kong
facility: Hong Kong Young Women's Christian Association
Study officials:
affiliation: Chinese University of Hong Kong
name: Yuen Yu Chong, PhD
role: PRINCIPAL_INVESTIGATOR
References: