Stepped-Care Support for Children With Leukaemia

NCT07587411 | Enrolling By Invitation DMC

• 2 other identifiers: LeukemiaProtocol_2026_001ZZUIRB2025-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Leukemia

Keywords

Stepped care; leukemia; child emotional behavioral health

Outcome Measures

Primary Outcomes (3)

• Change in Strengths and Difficulties Questionnaire Total Difficulties Score From Baseline to 12 Weeks

  Child emotional and behavioural difficulties will be assessed using the Strengths and Difficulties Questionnaire total difficulties score. The total difficulties score is calculated from the emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems subscales. Scores range from 0 to 40. Higher scores indicate greater emotional and behavioural difficulties. Unit of Measure: Score on a scale Score Range: 0 to 40 Direction: Higher scores indicate greater emotional and behavioural difficulties.

  Baseline and 12 weeks

• Change in Paediatric Quality of Life Inventory Total Score From Baseline to 12 Weeks

  Child health-related quality of life will be assessed using the Paediatric Quality of Life Inventory. Scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life. Unit of Measure: Score on a scale Score Range: 0 to 100 Direction: Higher scores indicate better health-related quality of life.

  Baseline and 12 weeks

• Change in Patient Health Questionnaire-9 Total Score From Baseline to 12 Weeks

  Caregiver depressive symptoms will be assessed using the Patient Health Questionnaire-9. The PHQ-9 total score ranges from 0 to 27. Higher scores indicate greater severity of depressive symptoms. Unit of Measure: Score on a scale Score Range: 0 to 27 Direction: Higher scores indicate greater depressive symptom severity

  Baseline and 12 weeks

Secondary Outcomes (2)

• Change in Pediatric/Procedural Anxiety Distress Thermometer Score From Baseline to 12 Weeks

  Baseline and 12 weeks

• Change in Sleep Disturbance Scale for Children Total Score From Baseline to 12 Weeks

  Baseline and 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Step Care Intervention Participants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualised therapy along with routine care.

Behavioral: Step Care Intervention

Control Group

NO INTERVENTION

Routine Care and Treatment

Interventions

Step Care Intervention BEHAVIORAL

Participants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualized therapy along with routine care

Intervention Group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Khyber Pukhtoon Khwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will use a two-arm, parallel-group pilot randomized controlled trial model to evaluate a culturally adapted stepped-care psychosocial intervention for children with leukemia in Pakistan. Eligible child-caregiver dyads will be allocated to either the intervention group, receiving the stepped-care program plus routine pediatric oncology care, or the control group, receiving routine care only. The 12-week intervention progresses from low-intensity universal support to higher-intensity individualized care according to the child's emotional and behavioral 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 required. The model will assess feasibility, acceptability, fidelity, and preliminary emotional and behavioral outcomes to inform a future full-scale trial.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 14, 2026
• Study Start: June 10, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)