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

March 26, 2023 updated by: Yuen Yu CHONG, Chinese University of Hong Kong

Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of Children With Special Health Care Needs: A Non-randomised Controlled Feasibility Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Federation of Youth Groups
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Young Women's Christian Association
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Yang Memorial Methodist Social Service
        • Contact:
      • Sha Tin, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FACT Group
4-6 FACT consultation sessions, one weekly session, 45-60 mins per session. These sessions will be using online video conferencing platforms.
Behavioral: Focused Acceptance and Commitment Therapy

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:

  1. Awareness: Able to experience the present moment, able to take perspective on self
  2. Openness: Able to detach distressing private experiences and associated rules, able to take a non-judgemental, accepting stance towards painful material
  3. Engagement: Exhibits strong connection with values, able to sustain values-consistent action
Other: Waitlist Control Group
The waitlist control group participants will commence their intervention trial immediately after they complete their follow-up assessment.
Other: Waitlist Control
The waitlist control group participants will commence their FACT intervention immediately after they complete their follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental depressive symptoms
Time Frame: Change from baseline assessment to immediate and 3 months post-intervention
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.
Change from baseline assessment to immediate and 3 months post-intervention
Parental anxiety symptoms
Time Frame: Change from baseline assessment to immediate and 3 months post-intervention
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 and 3 months post-intervention
Parental Stress
Time Frame: Change from baseline assessment to immediate and 3 months post-intervention
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.
Change from baseline assessment to immediate and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Psychological Flexibility
Time Frame: Change from baseline assessment to immediate and 3 months post-intervention
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.
Change from baseline assessment to immediate and 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Anticipated)

March 14, 2024

Study Completion (Anticipated)

March 14, 2025

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTEC-2023-058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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