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

NCT05803252 | Completed DMC

• 1 other identifier: NTEC-2023-058
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Parental Psychological Flexibility

  Change from baseline assessment to immediate and 3 months post-intervention

Study Arms (2)

FACT Group

EXPERIMENTAL

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

Waitlist Control Group

OTHER

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

Other: Waitlist Control

Interventions

Focused Acceptance and Commitment Therapy BEHAVIORAL

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

FACT Group

Waitlist Control OTHER

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

Waitlist Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Christian Service: collaborator
• Hong Kong Federation of Youth Groups: collaborator
• Hong Kong Young Women's Christian Association: collaborator
• Yang Memorial Methodist Social Service: collaborator

Study Sites (5)

Hong Kong Christian Service

Hong Kong, Hong Kong

Location

Hong Kong Federation of Youth Groups

Hong Kong, Hong Kong

Location

Hong Kong Young Women's Christian Association

Hong Kong, Hong Kong

Location

Yang Memorial Methodist Social Service

Hong Kong, Hong Kong

Location

Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Learning Disabilities; Chronic Disease; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Child Development Disorders, Pervasive; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Assigned by the investigator but not randomized

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: March 15, 2023
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

HK (5)