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Stage-Matched Psychosocial Intervention for Parent Caregivers of Children With Leukemia in Pakistan

NCT07563335 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-04

No results posted yet for this study

Summary

This study aims to develop, implement, and evaluate a stage-matched psychosocial intervention to enhance the psychological adaptation of parent caregivers of children with leukemia in Pakistan. The intervention is based on the Transactional Family Adaptation Model and Double ABC-X Model of family stress. It will be tailored to meet the specific emotional and behavioral needs of caregivers at different stages of their child's treatment journey. The study consists of four stages: (1) needs assessment, (2) intervention design, (3) intervention refinement, and (4) a pilot randomized controlled trial. The intervention will be tested at two tertiary care hospitals in Pakistan, with an expected sample size of 88 parent caregivers. Outcomes will assess feasibility, acceptability, and preliminary efficacy in improving psychological adaptation, reducing distress, and enhancing coping skills among caregivers.

Conditions

  • Childhood Leukemia

Interventions

BEHAVIORAL

Stage-Matched Psychosocial Intervention

This is a culturally adapted, theory-informed psychosocial intervention aimed at improving psychological adaptation and reducing distress among parent caregivers of children with leukemia. The intervention is stage-matched to the caregiver's phase in the child's treatment process and will include psychoeducation, emotional validation, problem-solving skills, and dyadic communication support.

OTHER

Routine Medical Care

This arm consists of standard medical care provided to caregivers of children diagnosed with leukemia, without any additional psychosocial support intervention. The aim is to compare the outcomes of the intervention group with those receiving routine care.

Sponsors & Collaborators

  • Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2026-03-30
Completion
2026-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563335 on ClinicalTrials.gov