Video-conferencing FACT for Young Children With Special Needs

NCT06262646 | Completed DMC

• 1 other identifier: NTEC-2023-677
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility. Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context. Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up. Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone. Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population.

Conditions

Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Specific Learning Disorder; Communication Disorders; Motor Disorders

Keywords

Acceptance and Commitment Therapy; Children with Special Needs; Parental psychological health; Parenting stress; Psychological Interventions; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Parenting stress

  The Parental Stress Scale (PSS, 18-item, 5-point scale) will be used to 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 to immediate and 6 months post-intervention

Secondary Outcomes (4)

• Parental depressive symptoms

  Change from baseline to immediate and 6 months post-intervention

• Parental anxiety symptoms

  Change from baseline to immediate and 6 months post-intervention

• Parental Psychological Flexibility

  Change from baseline to immediate and 6 months post-intervention

• ACT Core Process Utilization

  Change from baseline to immediate and 6 months post-intervention

Study Arms (2)

FACT Group

EXPERIMENTAL

Parents will receive 4-6 FACT consultation sessions, one weekly session, 45-60 mins per session. These sessions will be one-on-one, conducted face-to-face or via video conferencing.

Behavioral: Focused Acceptance and Commitment Therapy

Control Group

ACTIVE COMPARATOR

Parents will receive standard parenting advice about positive parenting tips recommended by the Child Assessment Services under the Department of Health.

Other: Control Group

Interventions

Focused Acceptance and Commitment Therapy BEHAVIORAL

Trained FACT interventionists will be guided by manualized FACT intervention to identify how many psychopathological processes need support and which ACT process(es) need to work on first, then offer parents process-matched ACT intervention strategies following the principles of FACT. The intervention strategies include ACT metaphors, experiential exercises, audio-guided mindfulness exercises, guided imagery exercises and value clarification exercises. The FACT steps in each session depend on the client's situation/stage.

Also known as: FACT

FACT Group

Control Group OTHER

Both study groups will receive standard family support from collaborating NGOs.

Control Group

Eligibility Criteria

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

You may qualify if:

• Language and Residency: Must be a Cantonese-speaking Hong Kong resident aged 21 years or older.
• Child's age and health status: Must be cohabiting with a preschool or school-aged child (2-9 years old) diagnosed with or suspected of having special needs.
• Caregiver role: Must be the primary caregiver responsible for daily care for the child.
• Technology access: Must have daily access to a smartphone, with either an iPhone or Android operating system, to participate in the study and for potential app-based interventions or communications.

You may not qualify if:

• Any parents with severe mental illness, are pregnant, are less than six months postpartum, or have a developmental disability that interferes with their ability to comprehend the programme's content.

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
• Hong Kong Sheng Kung Hui Welfare Council Limited: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Specific Learning Disorder; Communication Disorders; Motor Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Learning Disabilities; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: February 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

HK (1)