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Pai.ACT Programme for Parents of Children With Special Healthcare Needs - Phase I

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05584059
Enrollment
150
Registered
2022-10-18
Start date
2022-12-01
Completion date
2025-12-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Chronic Disease, Development Delay, Neurodevelopmental Disorders

Keywords

Focused Acceptance and Commitment Therapy, Special health care needs, Mobile App, Machine Learning

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.

Interventions

This is an individual-based FACT counselling programme which composes of 4-6 sessions on a weekly basis (45-60mins/session). All the sessions are delivered by a trained FACT interventionist via either video-conferencing (e.g., Zoom or Windows Teams) or face-to-face format. The programme aims to increase the psychological flexibility of the parent, so that he/she is able to (i) experience the present moment and take perspective on self (i.e., Awareness); (ii) detach the distressing private experiences and associated rules and to take a non-judgemental, accepting stance toward the painful experiences (i.e., Openness) and (iii) exhibits strong connection with values and commit to values-consistent actions. The trained interventionist will use different ACT strategies in these sessions, including ACT metaphors, experiential exercises, guided mindfulness exercises, guided imagery exercises and values clarification exercises to reinforce the above principles.

Sponsors

Hong Kong Association of Youth Department
CollaboratorUNKNOWN
Hong Kong Christian Service
CollaboratorOTHER
Hong Kong Federation of Youth Groups
CollaboratorUNKNOWN
Hong Kong School Nurse Association
CollaboratorUNKNOWN
Hong Kong Young Women's Christian Association
CollaboratorOTHER
Yang Memorial Methodist Social Service
CollaboratorOTHER
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Parental depressive symptomsChange from baseline assessment to immediate post-assessmentThe 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 symptomsChange from baseline assessment to immediate post-assessmentThe 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 StressChange from baseline assessment to immediate post-assessmentThe 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

MeasureTime frameDescription
Parental Psychological FlexibilityChange from baseline assessment to immediate post-assessmentThe PsyFlex (6-item 5-point Likert Scale) will assess all the six therapeutic processes of Acceptance and Commitment Therapy (ACT). Each item refers to one of the core skills that ACT focuses on when developing psychological flexibility and well-being. The score is then interpreted such that higher scores represent higher psychological flexibility.

Countries

Hong Kong

Contacts

Primary ContactYuen Yu Chong, PhD
conniechong@cuhk.edu.hk(852) 3943 0665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026