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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803252
• Other study ID #: NTEC-2023-058
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: March 14, 2025

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: Yuen Yu CHONG, PhD
• Phone: (852) 3943 0665
• Email: conniechong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: March 14, 2025
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Chronic Disease
• Development Delay
• Disease
• Neurodevelopmental Disorders

Intervention

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: 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

Other:
• Waitlist Control
The waitlist control group participants will commence their FACT intervention immediately after they complete their follow-up assessment.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Christian Service	Hong Kong
Hong Kong	Hong Kong Federation of Youth Groups	Hong Kong
Hong Kong	Hong Kong Young Women's Christian Association	Hong Kong
Hong Kong	Yang Memorial Methodist Social Service	Hong Kong
Hong Kong	Chinese University of Hong Kong	Sha Tin

Sponsors (5)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hong Kong Christian Service, Hong Kong Federation of Youth Groups, Hong Kong Young Women's Christian Association, Yang Memorial Methodist Social Service

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline assessment to immediate and 3 months post-intervention
Primary	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 and 3 months post-intervention
Primary	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.	Change from baseline assessment to immediate and 3 months post-intervention
Secondary	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.	Change from baseline assessment to immediate and 3 months post-intervention