NCT07047378

Brief Summary

The purpose of the proposed randomized controlled trial is to evaluate the feasibility, acceptability, and potential effectiveness of Acceptance and Commitment Therapy (ACT) in reducing parental burnout and improving children's emotional and behavioral adjustment in families in Hong Kong over 3 months after the intervention. The findings will provide valuable and scientific insights to inform better parenting interventions and child protection policies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress38%
Apr 2025Apr 2028

Study Start

First participant enrolled

April 22, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

June 24, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

Child maltreatmentAcceptance and Commitment Therapy (ACT)Hong KongParental burnoutPsychological flexibilityFeasibilityAcceptabilityChild adjustmentChild emotionEmotional development

Outcome Measures

Primary Outcomes (2)

  • Parental Burnout

    The Parental Burnout Assessment (PBA, 23-item, 7-point Likert scale) will be employed to evaluate the level of parental burnout. The Chinese version of PBA has reported good internal consistency (Cronbach's α = \>.8), adequate construct validity (.66\~.79), and strong convergent validity in Chinese parents.

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

  • Children's emotional and behavioral adjustment

    The Strengths and Difficulties Questionnaire (SDQ, 25-item, 3-point Likert scale) will be used to assess children's emotional and behavioral adjustment. The Chinese version of SDQ demonstrates satisfactory internal consistency (Cronbach's α = .45-.90) and good test-retest reliability (coefficients = 0.8 to 0.85).

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

Secondary Outcomes (4)

  • Parental Psychological flexibility

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

  • Children's psychological flexibility

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

  • Adaptive parenting behaviors

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

  • Parent-Child Relationship Quality

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

Study Arms (2)

ACT Intervention Group

EXPERIMENTAL

Both ACT Intervention and the Control Group will receive standard services originally provided by Harmony House. For parents allocated to this experimental group, 6 sessions of the ACT-based parenting program, one weekly session, 90 minutes per session. For children allocated to this experimental group, 6 sessions of the child-focused ACT programme, one weekly session, 90 minutes per session.

Behavioral: ACT Intervention Group

Control Group

OTHER

Participants allocated to the Control Group will not receive the ACT intervention during the initial 3-month study period but will be offered the intervention afterward as part of a waitlist control design.

Other: control group

Interventions

For Parent ACT Group, parents will participate in a six-week, group-based ACT program integrated with behavioral parenting training based on positive parenting principles. Each session lasts two hours and includes 65 minutes of ACT-based activities (e.g., experiential exercises, guided imagery, mindfulness, values clarification, metaphors) and 25 minutes of parenting education and/or behavioral skills training. For Children ACT Group, children (aged 6-11) will also receive a child-focused ACT intervention to help them manage emotional challenges. Each session lasts two hours and includes 65 minutes of ACT-based activities (e.g., experiential exercises, guided imagery, mindfulness, values clarification, metaphors) and 25 minutes of behavioral skills training.

ACT Intervention Group

Participants allocated to the Control Group will not receive the ACT intervention but will continue to receive the standard services originally provided by Harmony House. These services constitute usual care and include initial assessments, individual counselling, group counselling, the provision of community resource information, and referrals. Control group participants will receive these supports as usual. This study will not alter their existing service arrangements in any way, nor will it add to or reduce the support they receive. Aside from not participating in the ACT program, the control group's experience will be identical to that of clients receiving regular services. After the intervention group completes the program, the control group will be offered the same course content (i.e., a waitlist intervention arrangement).

Control Group

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For the Parent ACT Group:
  • Cantonese-speaking Hong Kong residents between the ages of 19 and 65 years.
  • Primary caregivers of a child aged 3 to 11 years.
  • Have been identified by school social workers as being at risk of domestic violence or experiencing emotional distress.
  • For the Child ACT Group:
  • Cantonese-speaking Hong Kong residents between the ages of 3 and 11 years.
  • Have been identified by school social workers as being at risk of domestic violence or experiencing emotional distress.
  • Participants must have sufficient Cantonese language proficiency to understand and communicate during the intervention.
  • Both parents and children must provide informed consent to participate in the study and all related assessments.

You may not qualify if:

  • For the Parent ACT Group:
  • Parents diagnosed with severe mental illnesses.
  • Parents with a developmental disability that interferes with their ability to comprehend the program's content.
  • Parents with cognitive, language, communication, visual, or hearing impairments or disorders that could impede their understanding of the intervention content; or
  • Parents currently participate in other psychosocial, psychoeducational, or parenting interventions.
  • Parents with active substance abuse issues that may interfere with their ability to participate in or benefit from the program.
  • Parents whose children have been diagnosed with psychological or medical conditions.
  • For the Child ACT Group:
  • \. Children who have been diagnosed with psychological or medical conditions.
  • Families who are unable or unwilling to commit to attending the six-week sessions or completing follow-up assessments.
  • Families who lack access to transportation or other necessary resources to attend the intervention sessions
  • Parents and children who cannot understand or communicate in the language used in the intervention and assessments (i.e., Cantonese and Chinese).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harmony House Limited

Kwun Tong, Hong Kong

RECRUITING

Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor(s) is/are blind to the group assignment in this study since it employs single-blind masking. Because of the nature of the intervention, both participants and care providers (e.g., facilitator or therapist) are aware of the assigned condition. To minimize bias in data interpretation, the outcome assessor(s) do/does not have access to participant group assignment information.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment; Repeated measures (baseline, post-intervention, and 3-month follow-up) 2-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

April 22, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

As participants were not asked to provide consent for sharing their individual data with external researchers, IPD cannot be made available.

Locations