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

Primary Purpose

Neurodevelopmental Disorders, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Focused Acceptance and Commitment Therapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodevelopmental Disorders focused on measuring Focused Acceptance and Commitment Therapy, Special health care needs, Mobile App, Machine Learning

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hong Kong Christian ServiceRecruiting
  • Hong Kong Federation of Youth GroupsRecruiting
  • Hong Kong School Nurse AssociationRecruiting
  • Hong Kong Young Women's Christian AssociationRecruiting
  • Yang Memorial Methodist Social ServiceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FACT Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Parental Psychological Flexibility
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.

Full Information

First Posted
October 14, 2022
Last Updated
August 26, 2023
Sponsor
Chinese University of Hong Kong
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
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1. Study Identification

Unique Protocol Identification Number
NCT05584059
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FACT Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Focused Acceptance and Commitment Therapy
Intervention Description
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 Outcome Measure Information:
Title
Parental depressive symptoms
Description
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.
Time Frame
Change from baseline assessment to immediate post-assessment
Title
Parental anxiety symptoms
Description
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.
Time Frame
Change from baseline assessment to immediate post-assessment
Title
Parental Stress
Description
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.
Time Frame
Change from baseline assessment to immediate post-assessment
Secondary Outcome Measure Information:
Title
Parental Psychological Flexibility
Description
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.
Time Frame
Change from baseline assessment to immediate post-assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuen Yu Chong, PhD
Phone
(852) 3943 0665
Email
conniechong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuen Yu Chong, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Christian Service
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jam Yau
Email
jamyau@cuhk.edu.hk
Facility Name
Hong Kong Federation of Youth Groups
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jam Yau
Email
jamyau@cuhk.edu.hk
Facility Name
Hong Kong School Nurse Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jam Yau
Email
jamyau@cuhk.edu.hk
Facility Name
Hong Kong Young Women's Christian Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jam Yau
Email
jamyau@cuhk.edu.hk
Facility Name
Yang Memorial Methodist Social Service
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jam Yau
Email
jamyau@cuhk.edu.hk

12. IPD Sharing Statement

Learn more about this trial

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

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