Clinical trial NCT05584059: Pai.ACT Programme for Parents of Children With Special Healthcare Needs - Phase I
Official title: Pai.ACT: A Deep-Learning Mental Health Advisory System Using Acceptance and Commitment Therapy for Parents of Children With Special Healthcare Needs (Phase I)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorders
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Development Delay
Chronic Disease
Keywords: Focused Acceptance and Commitment Therapy
Special health care needs
Mobile App
Machine Learning
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Association of Youth Department
name: Hong Kong Christian Service
name: Hong Kong Federation of Youth Groups
name: Hong Kong School Nurse Association
name: Hong Kong Young Women's Christian Association
name: Yang Memorial Methodist Social Service
First posted: 2022-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Parental depressive symptoms
timeFrame: Change from baseline assessment to immediate post-assessment
measure: Parental anxiety symptoms
timeFrame: Change from baseline assessment to immediate post-assessment
measure: Parental Stress
timeFrame: Change from baseline assessment to immediate post-assessment
Secondary outcomes:
measure: Parental Psychological Flexibility
timeFrame: Change from baseline assessment to immediate post-assessment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Christian Service
city: Hong Kong
country: Hong Kong
facility: Hong Kong Federation of Youth Groups
city: Hong Kong
country: Hong Kong
facility: Hong Kong School Nurse Association
city: Hong Kong
country: Hong Kong
facility: Hong Kong Young Women's Christian Association
city: Hong Kong
country: Hong Kong
facility: Yang Memorial Methodist Social Service
Study officials:
affiliation: Chinese University of Hong Kong
name: Yuen Yu Chong, PhD
role: PRINCIPAL_INVESTIGATOR
References: