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NCT Number: NCT07033832

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The Depression Anxiety Stress Scale (Chinese version)

    Time frame: baseline, week 4

    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.

  2. Psychological flexibility (Chinese version)

    Time frame: baseline, week 4

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Winsome Lam, PhD

CONTACT

[email protected]

852-2766 ext. 4291

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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