NCT07345806

Brief Summary

Parenting children with special health care needs can be stressful and weigh on the caregivers' mental health. For the individuals with special needs, the mismatch between their needs and the normative practice in the world around them can be frustrating and detrimental to their functioning. The demands and concerns to these families can be so real that it may not be sensible to examine the validity or helpfulness of the distressing thoughts or feelings but to promote psychological flexibility, which is a key to value-guided living. This pilot study explores the effects and feasibility of a group-based intervention for families of individuals with special health care needs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Oct 2025Mar 2027

Study Start

First participant enrolled

October 14, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Parenting StressPsychological Flexibility

Keywords

Acceptance and Commitment TherapyAdults with SENsParents of Children with SENs

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline in Psychological Flexibility as Measured by the Multidimensional Psychological Flexibility Inventory

    Score on psychological flexibility is the sum of scores across items

    From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment

  • Change from Baseline in Psychological Inflexibility as Measured by the Multidimensional Psychological Flexibility Inventory

    Score on psychological inflexibility is the sum of scores across items

    From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment

  • Change from Baseline in Psychological Well-being as Measured by the 5-Item World Health Organization Well-being Index

    Score on psychological well-being is the sum of scores across items

    From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment

  • Change from Baseline in Parenting Stress as Measured by the Parenting Stress Scale

    Score on parenting stress is the sum of scores across items

    From baseline to six weeks into treatment

Secondary Outcomes (4)

  • Change from Baseline in Child Externalizing as Measured by the Strengths and Difficulties Questionnaire

    From baseline to six weeks into treatment (i.e., post-intervention)

  • Change from Baseline in Child Internalizing as Measured by the Strengths and Difficulties Questionnaire

    From baseline to six weeks into treatment (i.e., post-intervention)

  • Participants' Satisfaction with the Intervention Program

    Six-week into treatment (i.e., post-intervention)

  • Participants' Personal Narratives on Their Experience with the Intervention Program

    Within six weeks after completing the treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Acceptance and Commitment Therapy

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

Acceptance and Commitment Therapy (ACT) is a well-established and evidence-based psychotherapy for individuals at different ages and with different clinical needs. The protocol used in the current study is adapted from an established local group intervention and tailored to families of individuals with special health care needs.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be at or older than 18 years old
  • understand Cantonese
  • read as well as write Chinese

You may not qualify if:

  • with borderline or greater intellectual deficits
  • weak language abilities
  • severe conditions related to mental, emotional, and/or behavioral functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Salvation Army SKY Family and Child Development Centre

Mong Kok, Hong Kong

RECRUITING

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Pui Man Chan

CONTACT

+852-36190191sky.rse@hkm.salvationarmy.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 16, 2026

Study Start

October 14, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)