Clinical trial NCT05803252: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Christian Service
name: Hong Kong Federation of Youth Groups
name: Hong Kong Young Women's Christian Association
name: Yang Memorial Methodist Social Service
First posted: 2023-04-07
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assigned by the investigator but not randomized
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parental depressive symptoms
timeFrame: Change from baseline assessment to immediate and 3 months post-intervention
measure: Parental anxiety symptoms
timeFrame: Change from baseline assessment to immediate and 3 months post-intervention
measure: Parental Stress
timeFrame: Change from baseline assessment to immediate and 3 months post-intervention
Secondary outcomes:
measure: Parental Psychological Flexibility
timeFrame: Change from baseline assessment to immediate and 3 months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Christian Service
city: Hong Kong
country: Hong Kong
facility: Hong Kong Federation of Youth Groups
city: Hong Kong
country: Hong Kong
facility: Hong Kong Young Women's Christian Association
city: Hong Kong
country: Hong Kong
facility: Yang Memorial Methodist Social Service
city: Sha Tin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References: