Stepped-Care Support for Children With Leukaemia

Enrolling by invitation · Not applicable

Conditions studied: Childhood Leukemia

In brief

This study aims to develop, culturally adapt, and pilot test a stepped-care psychosocial intervention designed to improve emotional and behavioral health among children with leukemia in Pakistan. Children with leukemia may experience anxiety, depressive symptoms, irritability, sleep disturbance, social withdrawal, treatment-related distress, and behavioral difficulties during the cancer treatment pathway. In resource-constrained settings, structured psychosocial care is often limited or unavailable within routine pediatric oncology services. This study addresses this gap by developing a feasible, culturally responsive, and theory-informed intervention that can be delivered within existing clinical resources. The study follows a multi-stage intervention-development process guided by the Intervention Mapping framework and Medical Research Council guidance for complex interventions. The stages include: evidence review and expert consultation to identify gaps in current psychosocial care; mixed-methods needs assessment with children, caregivers, and healthcare professionals; refinement of the intervention through focus groups and an e-Delphi process; and pilot testing of the intervention in a two-arm pilot randomized controlled trial. The pilot trial will include children aged 7 to 14 years with leukemia who are clinically stable and in the remission or maintenance phase of treatment, together with their primary caregivers. Participants will be allocated to either the stepped-care intervention plus routine care or routine care alone. The stepped-care program is delivered over 12 weeks and progresses from low-intensity universal support to more intensive individualized care according to child and family needs. Intervention components include an information booklet, psychoeducational video, face-to-face psychoeducation, peer support, cognitive behavioral strategies, parent-child behavioral training, and one-to-one therapy or referral when indicated. The intervention will be delivered by trained mental health nurses under supervision of a psychologist. The primary focus of this pilot trial is feasibility and acceptability, including recruitment, retention, attendance, intervention fidelity, completion of outcome measures, and participant satisfaction. Secondary exploratory outcomes include emotional and behavioral functioning, distress, quality of life, depressive symptoms, sleep disturbance, treatment adherence, and family functioning. Findings will guide refinement of the intervention and inform the design of a future fully powered randomized controlled trial.

Key facts

Study ID: NCT07587411
Run by: Zhengzhou University
People needed: 96
Starts: 2025-06-10
Expected to finish: 2026-12-30
Last updated by the study team: 2026-05-18

Who can join

Age: 7 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children diagnosed with leukaemia (confirmed by medical records).
Aged between 7 and 14 years at the time of diagnosis.
Primary carers (parents, guardians, or immediate family members) who are directly involved in the child's care and treatment.
Ability to comprehend and communicate in the local language (e.g., Urdu, Pashto).
Child in the stable remission or maintenance phase of leukaemia treatment.
Willingness to participate in the study and provide informed consent (child assent and parental consent).

You may not qualify if…

Acute medical instability requiring intensive care.
Cognitive impairment preventing meaningful participation.
Severe mental health conditions (e.g., active psychosis, extreme depression) in the child.
Non-primary carers without direct responsibility for the child's care.
Active substance abuse or impairing conditions in the primary carer.
Non-English/non-Urdu/Pashto-speaking participants.

Where it is running

Hayatabad Medical Complex — Peshawar, Khyber Pukhtoon Khwa, Pakistan

Full record on ClinicalTrials.gov

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