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

NCT ID: NCT07033832

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2026-06-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ACT-based intervention

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Winsome Lam

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Winsome LAM, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, , China

Site Status: RECRUITING

School of Nursing The Hong Kong polytechnic university

Kowloon, , Hong Kong

Site Status: NOT_YET_RECRUITING

Countries

China; Hong Kong

Central Contacts

Winsome Lam, PhD

Role: CONTACT

winsome.lam@polyu.edu.hk

852-2766 ext. 4291

Facility Contacts

Winsome Lam, PhD

Role: primary

winsome.lam@polyu.edu.hk

2766 ext. 4291

winsome LAM, PhD

Role: primary

winsome.lam@polyu.edu.hk

27664291

Other Identifiers

PilotACT

Identifier Type: -

Identifier Source: org_study_id