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Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of SHCN Children

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
Waitlist Control
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 Special health care needs (SHCN), Parental well-being, Family functioning, Acceptance and Commitment Therapy (ACT), Hong Kong, Focused Acceptance Commitment Therapy (FACT), Psychological flexibility, Feasibility, Acceptability, Waitlist control group, Mental well-being

Eligibility Criteria

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

Inclusion Criteria: Cantonese-speaking Hong Kong residents aged ≥21 years; living together with the child who is at preschool/school-age (3-9 years old); adopt the responsibility of taking care of the child; access to reliable Internet access via either computers and/or smartphones and be committed to maintaining internet access for the duration of the intervention 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 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 cognitive deficiency, severe mental illness and/or disability conditions that interfere with their ability to comprehend the programme's content had substance/alcohol dependency problems, are pregnant; are less than six months postpartum

Sites / Locations

  • Hong Kong Christian ServiceRecruiting
  • Hong Kong Federation of Youth GroupsRecruiting
  • Hong Kong Young Women's Christian AssociationRecruiting
  • Yang Memorial Methodist Social ServiceRecruiting
  • Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

FACT Group

Waitlist Control Group

Arm Description

4-6 FACT consultation sessions, one weekly session, 45-60 mins per session. These sessions will be using online video conferencing platforms.

The waitlist control group participants will commence their intervention trial immediately after they complete their follow-up assessment.

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 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, 18-item, 5-point scale) will 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 (5-point Likert scale, 6 items) will be used to assess the six therapeutic processes in ACT, namely contacting the present moment, defusion, acceptance, self-as-context, values and committed action.

Full Information

First Posted
March 26, 2023
Last Updated
March 26, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Christian Service, Hong Kong Federation of Youth Groups, Hong Kong Young Women's Christian Association, Yang Memorial Methodist Social Service
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1. Study Identification

Unique Protocol Identification Number
NCT05803252
Brief Title
Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of SHCN Children
Official Title
Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of Children With Special Health Care Needs: A Non-randomised Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
March 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Christian Service, Hong Kong Federation of Youth Groups, 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
The purpose of the proposed non-randomized waitlist-controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a Videoconferencing-based Individual Focused Acceptance and Commitment Therapy (FACT) approach to enhance the mental well-being of parents of children with special healthcare needs (SHCN) over a three-month period after the intervention has taken place.
Detailed Description
Parents of children with special health care needs (SHCN) have always been under tremendous pressure to care for their children. The parental well-being, as well as family functioning, are at risk. In literature, there has been increasing evidence supporting the efficacy of Acceptance and Commitment Therapy (ACT) on mental health in different populations, including healthy individuals, parents, children and those with mental health problems. The previous studies done by the PI in using ACT for improving parental well-being and management have proven the intervention effective for Hong Kong parents. Her work showed that ACT training effectively enhanced the parental well-being of parents of children with asthma and autism spectrum disorder. Though the result was promising, the previous clinical trials in Hong Kong showed a limited effect size. This is due to the need for extensive manpower in ACT intervention, yet there are very limited trained ACT interventionists in Hong Kong. On top of that, past interventions have failed to target impaired psychopathological processes as well as identify and determine which psychopathological processes require intervention in the first place. This study aims to overcome the limitations mentioned above. The proposed study will follow the model and principles of Focused Acceptance Commitment Therapy (FACT) to increase the psychological flexibility of parents of children with SHCN. FACT is a new model of brief therapy that is a highly condensed version of Acceptance and Commitment Therapy, which has been proven to be effective in the long term in improving one's mental well-being through increasing one's psychological flexibility. The time-limited and brief FACT intervention targets the impaired psychopathological processes and determines what process(es) need to work on first, which also eases the demand for ACT interventionists. This study aims to evaluate the feasibility, acceptability, and possible effectiveness of Videoconferencing-based Individual Focused Acceptance and Commitment Therapy (FACT) in enhancing the mental health of parents of children with special healthcare needs (SHCN) by comparing the results to those of a waitlist control group. The study will assess the well-being of the participating parents before the intervention, immediately after the intervention and again three months later to determine the impact of the FACT intervention on their mental well-being.

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
Special health care needs (SHCN), Parental well-being, Family functioning, Acceptance and Commitment Therapy (ACT), Hong Kong, Focused Acceptance Commitment Therapy (FACT), Psychological flexibility, Feasibility, Acceptability, Waitlist control group, Mental well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assigned by the investigator but not randomized
Masking
Outcomes Assessor
Masking Description
Single-blinded
Allocation
Non-Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FACT Group
Arm Type
Experimental
Arm Description
4-6 FACT consultation sessions, one weekly session, 45-60 mins per session. These sessions will be using online video conferencing platforms.
Arm Title
Waitlist Control Group
Arm Type
Other
Arm Description
The waitlist control group participants will commence their intervention trial immediately after they complete their follow-up assessment.
Intervention Type
Behavioral
Intervention Name(s)
Focused Acceptance and Commitment Therapy
Intervention Description
FACT aims to increase one's psychological flexibility so that one will not generate feelings of distress and suffering when confronted with painful life situations. The intervention of this study will follow the FACT principles laid out by Strosahl, Robinson and Gustavsson to increase parents' psychological flexibility. Three core processes influence one's psychological flexibility: awareness, openness, and engagement. The key objectives of each core process are: Awareness: Able to experience the present moment, able to take perspective on self Openness: Able to detach distressing private experiences and associated rules, able to take a non-judgemental, accepting stance towards painful material Engagement: Exhibits strong connection with values, able to sustain values-consistent action
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Intervention Description
The waitlist control group participants will commence their FACT intervention immediately after they complete their follow-up assessment.
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 test-retest correlation coefficient.
Time Frame
Change from baseline assessment to immediate and 3 months post-intervention
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 and 3 months post-intervention
Title
Parental Stress
Description
The Parental Stress Scale (PSS, 18-item, 5-point scale) will 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 and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Parental Psychological Flexibility
Description
The PsyFlex (5-point Likert scale, 6 items) will be used to assess the six therapeutic processes in ACT, namely contacting the present moment, defusion, acceptance, self-as-context, values and committed action.
Time Frame
Change from baseline assessment to immediate and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cantonese-speaking Hong Kong residents aged ≥21 years; living together with the child who is at preschool/school-age (3-9 years old); adopt the responsibility of taking care of the child; access to reliable Internet access via either computers and/or smartphones and be committed to maintaining internet access for the duration of the intervention 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 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 cognitive deficiency, severe mental illness and/or disability conditions that interfere with their ability to comprehend the programme's content had substance/alcohol dependency problems, are pregnant; are less than six months postpartum
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
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Tik YAU
Phone
(852) 3943 9915
Email
jamyau@cuhk.edu.hk
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
Pui Tik 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
Pui Tik 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
Pui Tik 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
Pui Tik YAU
Email
jamyau@cuhk.edu.hk
Facility Name
Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Tik YAU
Phone
(852) 3943-9915
Email
jamyau@cuhk.edu.hk

12. IPD Sharing Statement

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Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of SHCN Children

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