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Clinical Trials/NCT05584059
NCT05584059
Recruiting
Not Applicable

Pai.ACT: A Deep-Learning Mental Health Advisory System Using Acceptance and Commitment Therapy for Parents of Children With Special Healthcare Needs (Phase I)

Chinese University of Hong Kong5 sites in 1 country150 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurodevelopmental Disorders
Sponsor
Chinese University of Hong Kong
Enrollment
150
Locations
5
Primary Endpoint
Parental depressive symptoms
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.

Detailed Description

Parents of children with Special Health Care Needs (SHCN) have always been under tremendous pressure to care for their children. They have been experiencing significant caregiving difficulties, such as scheduling and accompanying multiple follow-ups for rehabilitation and functional recovery and managing the child's symptoms and problematic behaviours. With the strike of COVID-19, these parents' stress may even be exacerbated due to the lockdown measures. Children's needs become more demanding with the suspension of the usual care services. Parenting stress has been known to affect parent-child interactions and increase negative parenting behaviours such as harsh, permissive or neglecting parenting impairing the parent's capacity to respond to the demands of the child's illness, which may, in turn, exacerbate the child's health problem and well-being. Recent evidence has advocated the efficacy of Acceptance and Commitment Therapy (ACT) on mental health in different population groups, including healthy individuals, parents, children and those with mental health problems. To increase the reach of ACT and overcome the plausible disruptions of mental health services arising from the pandemic, the study proposes to use an innovative intervention approach, that is a brief version of ACT (Focused ACT), delivered by trained FACT interventionists in individual-based, video-conferencing format. The conversation data between the parent and the interventionist will be further analyzed for developing a Deep-Learning Mental Health Advisory System in the second phase of the Pai.ACT project. This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing-based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yuen Yu CHONG

Assistant Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Cantonese-speaking Hong Kong residents
  • living together with the child who is at preschool/school-age (3-9 years old)
  • adopt 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 with severe mental illness or developmental disabilities which impaired their ability to comprehend the content of the programme will be excluded.

Outcomes

Primary Outcomes

Parental depressive symptoms

Time Frame: Change from baseline assessment to immediate post-assessment

The Patient Health Questionnaire (PHQ-9, 9-item, 4-point Likert scale) will be used to assess the frequency of the parents experiencing depressive symptoms in the past two weeks. The Chinese version of the PHQ-9 has demonstrated good internal consistency reliability (Cronbach's alpha = 0.86) and a 2-week test-retest correlation coefficient.

Parental anxiety symptoms

Time Frame: Change from baseline assessment to immediate post-assessment

The Generalized Anxiety Disorder-7 (GAD-7, 7-item, 4-point Likert scale) will be used to measure the severity of anxiety symptoms. The Chinese version of the GAD-7 demonstrated good reliability and validity with a Cronbach's coefficient of 0.91.

Parental Stress

Time Frame: Change from baseline assessment to immediate post-assessment

The Parental Stress Scale (PSS, 16-item, 5-point scale) will be used to assess parenting stress. A higher score represents a higher level of parental stress. The Chinese version of the PSS has demonstrated acceptable psychometric properties and is therefore suitable for use by researchers to assess the parental stress levels of Chinese parents.

Secondary Outcomes

  • Parental Psychological Flexibility(Change from baseline assessment to immediate post-assessment)

Study Sites (5)

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