Acceptance and Commitment Therapy-based Intervention for Parents of a Child With Medical Complexity

NCT07033832 | Recruiting

• 1 other identifier: PilotACT
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

A pilot randomized controlled trial of an Acceptance and Commitment Therapy-based intervention will be conducted to decrease psychological symptoms, while increase psychological flexibility for parents of a child with medical complexity during their difficulties.

Conditions

Acceptance and Commitment Therapy; Child With Medical Complexity; Psychological Flexibility; Randomised Controlled Trial; Depression, Anxiety; Parental Stress

Outcome Measures

Primary Outcomes (2)

• The Depression Anxiety Stress Scale (Chinese version)

  The DASS is a self-report instrument consisting of 21 items. It is rated on a 4-point scale from 1 (does not apply to me at all) to 4 (applies to me all the time). A higher score on the scale indicates more psychological symptoms.

  baseline, week 4

• Psychological flexibility (Chinese version)

  The Acceptance and Action Questionnaire-II was used to assess the psychological flexibility of parents. It consists of 7 items and is reported by the parent. Each item is rated on a 7-point Likert scale, ranging from 1 (never true) to 7 (always true).

  baseline, week 4

Study Arms (2)

ACT-based intervention

EXPERIMENTAL

The ACT-based intervention consists of four face-to-face weekly sessions. Parents in this group will receive two-hour weekly session with the question-and-answer session at the end.

Behavioral: ACT-based intervention

Control group

NO INTERVENTION

Parents of CMC have option to join the usual community social or health care available in the community.

Interventions

ACT-based intervention BEHAVIORAL

Parents in this group will receive two-hour weekly session with the question-and-answer session at the end. The contents of each session are as follows: (1) the first session consist of introductions of ACT, discussion on stress and struggles, and setting homework, (2) the second section includes role play, and the meaning of "value", (3) the third session involves introducing mindfulness of the breath exercise, debrief and homework on practicing mindfulness and (4) the last session includes introduction of "thoughts", and putting values into feasible actions.

ACT-based intervention

Eligibility Criteria

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

You may qualify if:

• parent of a child with medical complexity aged 1-18
• able to communicate in Chinese and read Chinese
• willing to participate in face-to-face activities

You may not qualify if:

• a reported mental health disorder
• engaging in other psychosocial educational programs related to stress reduction
• inability to communicate in Cantonese

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

School of Nursing The Hong Kong polytechnic university

Kowloon, 852, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Winsome LAM, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winsome Lam, PhD

CONTACT

852-2766; winsome.lam@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The project assistant who does not involve in intervention assignment and randomization, will help to conduct the data collection
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: single-blinded, pilot randomized controlled trial with two-armed repeated measures

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 24, 2025
• Study Start: July 2, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

CN (1); HK (1)