NCT07814911

Brief Summary

The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. The main questions it aims to answer are:

  • Does a group-based ACT improve the psychological flexibility of the participants?
  • Does a group-based ACT improve the psychological distress, including depression, anxiety, and stress, of the participants?
  • Does a group-based ACT improve the QOL of the participants? Researchers will compare a group-based ACT to usual/standard care to determine whether ACT improves participants' psychological outcomes and QOL. Participants will:
  • Receive eight weekly, face-to-face, group-based ACT sessions, each lasting approximately 90 minutes.
  • Receive home-based practices following each session.
  • Receive a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
  • Complete the questionnaires at three times: baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress3%
Oct 2026Jan 2027

First Submitted

Initial submission to the registry

September 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 6, 2026

Last Update Submit

September 6, 2026

Conditions

Psychological OutcomesQuality of Life

Keywords

Acceptance and Commitment TherapyPsychological outcomeAnxietyDepressionStressPsychological flexibilityQuality of lifeChildParentCerebral palsy

Outcome Measures

Primary Outcomes (2)

  • Level of psychological flexibility

    The psychological flexibility will be assessed using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Each item in the AAQ-II is scored on a scale of seven from 1(never true) to 7(always true). The total score is obtained by summing the scores of all items, and the higher the total score indicates greater psychological inflexibility.

    Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

  • Level of psychological distress

    The psychological distress outcomes including, anxiety, depression, and stress will be assessed using the self-report 21-item anxiety, depression, and stress scale (DASS-21). Each of the subscales comprises 7 items and is scored on a four-point Likert scale ranging from 0(didn't apply at all to me) to 3(applied to me very much or most of the time), and the score is calculated by summing up the items in each subscale, and the final core is obtained by multiplying the core by two to make it comparable with the full scale (DASS-42). The higher the core indicates high distress symptoms.

    Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

Secondary Outcomes (1)

  • Level of quality of life

    Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

Study Arms (2)

ACT intervention

EXPERIMENTAL
Behavioral: ACT intervention

Usual/standard treatment

OTHER
Other: Usual/standard control

Interventions

ACT interventionBEHAVIORAL

Participants in the intervention group will receive an ACT that consists of eight sessions. Th introductions include an introduction, cognitive defusion, acceptance, being present, values, committed action, and noticing self/self-as context, and a summary session. An ACT-trained researcher will deliver weekly, face-to-face, group-based sessions, each lasting approximately 90 minutes, though durations may vary to accommodate group variations. Each group will consist of five to seven participants. The interventions will be delivered via various strategies, including psychoeducation, discussion, mindfulness exercises, and metaphors supplemented with with home practices. A research assistant will conduct a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.

ACT intervention
Usual/standard controlOTHER

Participants in the control group will receive the usual or standard care provided by the respective center. To enhance participant retention in the study, a weekly phone call will be conducted by a research assistant, during which participants will be asked whether they have any concerns about the study and reminded of the next appointment or assessment day.

Usual/standard treatment

Eligibility Criteria

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

You may qualify if:

  • Parents of children under 18 years with any type and severity of cerebral palsy
  • Able to communicate in Amharic, and
  • Able to provide written consent for participation

You may not qualify if:

  • Participants who have known psychological or psychiatric problems, and
  • Participants who are currently participating or have participated in another similar or related study within six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepressionCerebral Palsy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Kenneth N.K Fong, PhD

CONTACT

+852 2766 6716rsnkfong@polyu.edu.hk

Tenaw Gualu Melesse, PhD

CONTACT

+852 5530 4750tgmeles@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2026

First Posted

September 11, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share