PACT Programme for Parents of Children With SHCN

NCT05467527 | Recruiting DMC

• 1 other identifier: 2191269
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

Brief Summary

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

Conditions

Urologic Diseases; Gastrointestinal Diseases; Vascular Diseases; Cleft Lip and Palate; Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Developmental Delay

Keywords

Acceptance and Commitment Therapy; Randomised Controlled Trial; Special health care needs; novel infectious disease; prosociality

Outcome Measures

Primary Outcomes (2)

• Parental mental well-being

  The 14-item Mental Health Continuum Short Form for Adults (MHC-SF) will be used to assess the emotional, social and psychological well-being of parents. MHC-SF can be scored between 0 and 5 (6 points Likert scale), which means that the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. scaleThe MHC-SF subscales possessed good convergent validity and internal consistencies in Western populations (Lamers et al., 2011).

  Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

• Child mental well-being

  The 25-item Strengths and Difficulties Questionnaire (SDQ, 25 items, 3-point Likert scale) will be adopted to evaluate the psychological adjustment of children with SHCN, in terms of conduct problems, hyperactivity, emotional symptoms, peer problems and prosocial behaviours. A total difficulties score can be generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40. The SDQ is one of the most commonly used proxy reports from parents to assess the psychopathology of their children aged 3-16 years (Lai et al., 2010).

  Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

Secondary Outcomes (4)

• Parental psychological flexibility

  Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

• Parental prosociality

  Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

• Parenting competence

  Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

• Family functioning

  Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

Study Arms (2)

PACT Group

EXPERIMENTAL

A combination of 6 online modules and 4 group-based video conferencing sessions of Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice via a mobile app across 12 weeks

Behavioral: Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice

Control Group

PLACEBO COMPARATOR

A combination of 6 online modules and 4 group-based video conferencing sessions of daily parenting challenges in caring for a child with SHCN plus positive parenting advice via a mobile app across 12 weeks

Behavioral: Positive parenting advice

Interventions

Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice BEHAVIORAL

The PACT group will receive a combination of 6 online modules and 4 group-based video conferencing sessions of Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice via a mobile app across 12 weeks. The modules will cover real-life scenarios of daily parenting challenges in caring for a child with SHCN, followed by age-appropriate positive parenting advice based on the Centers for Disease Control and Prevention guidelines. After going through the scenarios, parents will be audio/visually guided to participate in ACT activities, including mindfulness exercises, ACT metaphors and experiential exercises, which will be used to increase psychological flexibility.

PACT Group

Positive parenting advice BEHAVIORAL

The Control Group will receive a total of 6 online modules and 4 group-based video conferencing sessions in a closed group of 6-8, 60 minutes per session guided by a trained facilitator via the mobile app across 12 weeks. The online modules will provide identical contents to those in the PACT group, but no guided ACT metaphors or experiential exercises. The interaction sessions serve to review and discuss the contents of online modules, but without the contents related to ACT/prosociality.

Control 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 (3-8 years old)
• Caregivers who adopted 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 who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Children's Hospital: collaborator
• Hong Kong Young Women's Christian Association: collaborator

Study Sites (2)

Department of Surgery, Hong Kong Children's Hospital

Ngau Tau Kok, Kowloon, Hong Kong

RECRUITING

Hong Kong Young Women's Christian Association

Kowloon, Hong Kong

COMPLETED

MeSH Terms

Conditions

Urologic Diseases; Gastrointestinal Diseases; Vascular Diseases; Cleft Lip; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Learning Disabilities

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Cardiovascular Diseases; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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

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

Wing Suet Hung

CONTACT

hws820@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomisation procedure will be carried by a clerical staff who has no involvements in this project. For parents, all participants will use the same mobile app tentatively branded as "Calm Parents" but receive different assigned contents of the app.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, The Nethersole School of Nursing, CUHK

Model Details: Parallel Assignment; repeated-measures 2-arm randomized controlled trial

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: June 27, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

HK (2)