NCT04870697

Acceptance and Commitment Therapy for Parents of Children With Cancer

Effects of Acceptance and Commitment Therapy on Promoting Parental Quality of Life and Reducing Psychological Distress in Parents of Children With Cancer: A Randomized Controlled Trial Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The current study aims to develop a theoretically driven ACT intervention and examine its effects among parents of children with cancer. The objectives are: 1. To examine the effects of ACT intervention on parental QOL and psychological distress (symptoms of anxiety, depression and stress) in parents of children with cancer. 2. To examine the effects of ACT intervention on parental negative experience, experiential avoidance and psychological flexibility in parents of children with cancer. 3. To examine the effects of ACT intervention on psychological adjustment of children with cancer.

Detailed description

A pilot study will be used to evaluate the feasibility and acceptability of ACT intervention protocol in Chinese parents of children with cancer. A two-arm parallel randomized controlled trial (RCT) will be used to evaluate the effects of ACT intervention in parents of children with cancer. Eligible participants will be randomly assigned into a 1:1 allocation ratio to the ACT group or control group using block randomization with random mixture blocks of 4, 6 and 8. This can avoid the greater frequency of assignments to either group and lead to more balanced treatment groups in size and key outcome-related characteristics over time while reducing the predictability of assignment from the preceding assignment. A sequence list of two group labels (1 = ACT group, 2 = Control group) will be generated using a computerized generation randomization tool by an independent statistician who is blinded to the meaning of group labels will not involve the other part of the study. The group allocation assignment labels will be contained in opaque sealed envelopes and concealed to all researchers and participants involved in this study until the research investigator has completed the assessments of the participant and obtained written consent during the recruitment. Considering the nature of the study, blinding of participants and ACT interventionists will be impossible. The research assistants involved in data collection and data entry as well as health routine care providers in the units of study hospital will be blinded to the group allocation. To prevent possible contamination, the ACT intervention for parents in the ACT group will be conducted in a meeting room in the staff area which is geographically separate from the patient area. Besides, the participants are required not to show ACT intervention materials to, nor discuss the intervention contents with other parents in the unit.

Conditions

• Childhood Cancer

Interventions

Type	Name	Description
BEHAVIORAL	ACT intervention	The components of ACT intervention will include six processes to foster parental PF according to the ACT framework. Session one - Generate creative hopelessness and build acceptance. The objective is to help parents know about the ACT intervention and realize the experiential avoidance or emotional control strategies do not work, finally turn attention to more useful strategies. Session two - Create space for your thought. The objective is to help parents create a distance from their thoughts and facilitate parents' ability of not being trapped by thoughts. Session three - Focus on here and now. The objectives to facilitate parents' experiences of observing self and contact with the present moment but not trapped in the past or future. Session four - Commit actions in line with the value. The objectives to help parents identify their inner value and take value-based actions even facing the challenges in current difficulties of their children with cancer.
OTHER	Usual care	Usual care in this study setting includes providing general information, education, psychological support, and consultation.

Timeline

• Start date: 2021-06-28
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2021-05-03
• Last updated: 2021-08-02

Locations

1 site across 1 country: China