Stepped-Care Support for Children With Leukaemia (STEP-Leukemia)

Developing a Stepped-Care Intervention for Emotional and Behavioral Health in Children With Leukemia: A Study Protocol

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Childhood Leukemia
• Intervention / Treatment: Behavioral: Step Care Intervention

Detailed Description

This study will develop, culturally adapt, and pilot evaluate a stepped-care psychosocial intervention to support emotional and behavioural health among children with leukaemia in Pakistan. Children undergoing treatment for leukaemia may experience anxiety, low mood, procedural fear, irritability, sleep disturbance, social withdrawal, school disruption, reduced quality of life, and difficulties with treatment routines. These challenges may also interact with caregiver distress and family functioning. In Pakistan and similar resource-constrained settings, paediatric oncology care is primarily focused on diagnosis, chemotherapy, and medical follow-up, while structured psychosocial screening and evidence-based psychological support are not routinely integrated into care. A culturally adapted stepped-care model may provide a practical approach by offering low-intensity support to all families and reserving more intensive psychosocial input for children and caregivers with greater or persistent needs.

The study is guided by Intervention Mapping and the Medical Research Council guidance for developing and evaluating complex interventions. A sequential, stage-based design will be used, with findings from each stage informing the next stage. The intervention-development process will include evidence synthesis, stakeholder consultation, mixed-methods needs assessment, intervention refinement, and pilot evaluation.

In the first stage, a scoping review and expert consultation will be conducted to identify existing evidence, contextual gaps, feasible intervention components, and implementation considerations relevant to paediatric oncology settings in Pakistan. In the second stage, a mixed-methods needs assessment will explore the emotional, behavioural, family, and service-related needs of children with leukaemia and their caregivers, as well as professional perspectives on feasible psychosocial care delivery. In the third stage, the draft intervention will be refined through feedback from children, caregivers, and multidisciplinary experts, including focus groups and a structured e-Delphi process. This stage will focus on cultural appropriateness, developmental suitability, session burden, delivery format, safety procedures, and stepped-care decision rules.

The final stage will pilot and evaluate the 12-week stepped-care intervention in comparison with routine care. The pilot evaluation is intended to assess feasibility, acceptability, implementation procedures, intervention fidelity, safety, and the suitability of outcome assessment procedures. It is not designed to establish definitive intervention effectiveness. Findings will be used to refine the intervention manual, delivery procedures, and future trial methods.

The stepped-care intervention is designed as a manualised psychosocial programme delivered by trained mental health nurses under psychologist supervision. The intervention includes universal psychoeducation for all participating families, followed by progressively more intensive components according to the child's and caregiver's level of need. Lower-intensity components include an information booklet, psychoeducational video, and face-to-face psychoeducation. Children and families with emerging or persistent psychosocial concerns may receive peer support, cognitive behavioural strategies, parent-child behavioural training, or one-to-one therapeutic support with referral to specialist services when clinically indicated.

The intervention is informed by the stepped-care model, cognitive behavioural theory, stress and coping theory, resilience theory, family systems theory, the social ecological model, and self-regulation theory. Together, these frameworks support the development of an intervention that addresses illness-related appraisal, coping skills, emotional regulation, family communication, social support, behavioural adjustment, and appropriate escalation of care.

Fidelity will be supported through a structured intervention manual, facilitator training, session checklists, intervention logs, and supervision meetings. Safety procedures will be used to identify and refer participants requiring urgent psychological or psychiatric care. Quantitative and qualitative findings from the pilot evaluation will be integrated to determine whether the intervention is feasible, acceptable, culturally appropriate, and suitable for refinement before a future fully powered randomized controlled trial.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pukhtoon Khwa
    • Peshawar, Khyber Pukhtoon Khwa, Pakistan, 25000
      • Hayatabad Medical Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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
No Intervention: Control Group; Routine Care and Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric/Procedural Anxiety Distress Thermometer Score From Baseline to 12 Weeks	Child procedural anxiety and distress will be assessed using the Paediatric/Procedural Anxiety Distress Thermometer. The score ranges from 0 to 10, with higher scores indicating greater anxiety or distress. Paediatric distress thermometer ratings commonly use a 0 to 10 scale, where 0 indicates no distress and 10 indicates high or extreme distress. Unit of Measure: Score on a scale Score Range: 0 to 10 Direction: Higher scores indicate greater anxiety or distress.	Baseline and 12 weeks
Change in Sleep Disturbance Scale for Children Total Score From Baseline to 12 Weeks	Child sleep disturbance will be assessed using the Sleep Disturbance Scale for Children. The scale includes 26 items rated on a 5-point Likert scale. The total score ranges from 26 to 130, with higher scores indicating greater sleep disturbance. Unit of Measure: Score on a scale Score Range: 26 to 130 Direction: Higher scores indicate greater sleep disturbance.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: leukemia; Stepped care; child emotional behavioral health
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia
• Other Study ID Numbers: LeukemiaProtocol_2026_001; ZZUIRB2025-03 (Other Identifier: Zhengzhou University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be subject to institutional ethics approval, participant confidentiality requirements, and a signed data-sharing agreement. No personally identifiable information will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No