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

Acceptance and Commitment Therapy-based Intervention to Decrease Psychological Symptoms and Increase Psychological Flexibility for Parents of a Child With Medical Complexity: a Pilot Randomization-controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Parental Stress; Depression, Anxiety; Acceptance and Commitment Therapy; Psychological Flexibility; Randomised Controlled Trial; Child With Medical Complexity
• Intervention / Treatment: Behavioral: ACT-based intervention

Detailed Description

Being a parent of the child with medical complexity poses enormous stress because CMC have a chronic complex health condition, which may result in premature death of the CMC. Psychological symptoms commonly experienced by the parents of a CMC. Having a CMC is an ongoing stressor including diagnosis, daily nursing care and symptom management, uncertainty of prognosis that can adequately fear the possibility of relapse. Therefore, seeking an intervention consisting of "Psychological flexibility" is crucial for these parents to manage their stress and difficult emotions more effectively. The ACT intervention help individuals concentrate more on their problems with positive attitude and take initiatives and workable actions to fix the problems associated from the caregiving activities. As a result, they will experience less stress when encountering difficulties and challenges and adapt more effectively. These individuals probably have the potential of natural recoveries from adverse events once the stressor is terminated.

Knowledge gap: A review of the literature reveals a paucity of studies on ACT for Chinese parents of the CMC to decrease their psychological symptoms while enhancing their psychological flexibility in local communities. To fill the knowledge gap, this proposal therefore endeavors to develop an ACT and test its preliminary effects and feasibility.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winsome Lam, PhD; Phone Number: 4291 852-2766; Email: winsome.lam@polyu.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • School of Nursing, The Hong Kong Polytechnic University
    • Contact: Winsome Lam, PhD; Phone Number: 4291 2766; Email: winsome.lam@polyu.edu.hk
• Hong Kong
  • Kowloon, Hong Kong, 852
    • Not yet recruiting
    • School of Nursing The Hong Kong Polytechnic University
    • Contact: winsome LAM, PhD; Phone Number: 27664291; Email: winsome.lam@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT-based intervention; 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; 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.
No Intervention: Control group; Parents of CMC have option to join the usual community social or health care available in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Winsome LAM, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 6, 2025
• First Submitted That Met QC Criteria: June 14, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: PilotACT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No