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NCT Number: NCT05584059

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Chronic Disease Communication Disorders Development Delay Disease Attributes Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Christian Service, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focused Acceptance and Commitment Therapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Parental Psychological Flexibility

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

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuen Yu Chong, PhD

CONTACT

[email protected]

(852) 3943 0665

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hong Kong Association of Youth Department
  • Hong Kong Christian Service
  • Hong Kong Federation of Youth Groups
  • Hong Kong School Nurse Association
  • Hong Kong Young Women's Christian Association
  • Yang Memorial Methodist Social Service

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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