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

NCT05584059 | Recruiting DMC

• 1 other identifier: ITB/FBL/6033/21/P
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (3)

• Parental depressive symptoms

  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.

  Change from baseline assessment to immediate post-assessment

• Parental anxiety symptoms

  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.

  Change from baseline assessment to immediate post-assessment

• Parental Stress

  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.

  Change from baseline assessment to immediate post-assessment

Secondary Outcomes (1)

• Parental Psychological Flexibility

  Change from baseline assessment to immediate post-assessment

Study Arms (1)

FACT Group

EXPERIMENTAL

4-6 weeks of 45-60 minute individual-based Focused Acceptance and Commitment Therapy (FACT) counselling sessions delivered via video-conferencing format or face-to-face

Behavioral: Focused Acceptance and Commitment Therapy

Interventions

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.

FACT Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Parents with severe mental illness or developmental disabilities which impaired their ability to comprehend the content of the programme will be excluded.

Sponsors & Collaborators

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

Study Sites (5)

Hong Kong Christian Service

Hong Kong, Hong Kong

RECRUITING

Hong Kong Federation of Youth Groups

Hong Kong, Hong Kong

RECRUITING

Hong Kong School Nurse Association

Hong Kong, Hong Kong

RECRUITING

Hong Kong Young Women's Christian Association

Hong Kong, Hong Kong

RECRUITING

Yang Memorial Methodist Social Service

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Learning Disabilities; Chronic Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Child Development Disorders, Pervasive; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Yuen Yu Chong, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuen Yu Chong, PhD

CONTACT

(852) 3943 0665; conniechong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

HK (5)