Stepped-Care Support for Children With Leukaemia

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.

• Change in Pediatric/Procedural Anxiety Distress Thermometer Score From Baseline to 12 Weeks [Срок оценки: Baseline and 12 weeks]
• Change in Sleep Disturbance Scale for Children Total Score From Baseline to 12 Weeks [Срок оценки: Baseline and 12 weeks]