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.

This study is designed to develop, implement, and evaluate a stage-matched psychosocial intervention aimed at enhancing the psychological adaptation of parent caregivers of children diagnosed with leukemia in Pakistan. The study will follow a multi-stage, mixed-methods approach and will be guided by the Intervention Mapping framework and the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The research will focus on developing a culturally adapted, theory-informed intervention that addresses the unique psychological and emotional challenges faced by caregivers in Pakistan.

Study Objectives:

The primary aim of the study is to develop a structured and culturally sensitive psychosocial intervention that enhances the psychological adaptation of parent caregivers. The study will also assess the feasibility, acceptability, and preliminary efficacy of the intervention in improving the well-being and coping capacity of caregivers.

Specific objectives of the study include:

1. Gap Definition (Stage 1): To identify the psychological adaptation gaps and caregiving challenges of parent caregivers through a systematic literature review and expert consultation.
2. Intervention Design (Stage 2): To design a culturally relevant stage-matched psychosocial intervention based on the findings from the needs assessment and expert reviews.
3. Model Refinement (Stage 3): To refine and finalize the intervention model based on feedback from focus groups and e-Delphi processes.
4. Pilot Trial (Stage 4): To conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and preliminary efficacy of the intervention.

Methodology:

The study will involve a needs assessment, intervention design, refinement through expert consultation, and a pilot trial. Each stage will involve multiple research activities aimed at identifying key psychological adaptation challenges and determining effective intervention strategies. The methodology will incorporate qualitative and quantitative approaches, including in-depth interviews, surveys, expert consultations, and a pilot RCT.

Stage 1: Gap Definition This stage will involve conducting a systematic literature review to assess existing psychosocial interventions for caregivers of children with leukemia. Expert consultations will provide additional insight into the psychological adaptation needs and challenges faced by caregivers in Pakistan. This will form the basis for understanding the gaps in current interventions and inform the design of a tailored stage-matched intervention.

Stage 2: Intervention Design In this stage, a mixed-methods needs assessment will be conducted with parent caregivers to identify specific psychological adaptation challenges at various stages of the child's treatment (e.g., diagnosis, active treatment, remission, and post-treatment). The intervention will integrate findings from the literature review, expert consultations, and needs assessment to create a culturally sensitive, theory-driven intervention that addresses these challenges. The intervention will be structured to provide psychosocial support at different stages of adaptation, ensuring that the level of support is appropriate for each phase of the illness trajectory.

Stage 3: Intervention Refinement Following the initial intervention design, the model will be refined using feedback obtained from focus groups with parent caregivers and an e-Delphi process with relevant experts (psychologists, oncologists, nurses). This stage will focus on improving the usability, acceptability, and cultural appropriateness of the intervention content and delivery methods.

Stage 4: Pilot Randomized Controlled Trial (RCT) A pilot RCT will be conducted to evaluate the feasibility and preliminary efficacy of the stage-matched intervention. The study will include 70 parent caregivers (35 per arm), randomized into the intervention and control groups. The intervention group will receive the stage-matched psychosocial support alongside routine medical care, while the control group will continue with standard care. The outcomes will assess psychological adaptation, distress, coping, and caregiver burden, as well as the impact on child treatment adherence.

Expected Outcomes:

The primary outcomes of the study will be:

1. Feasibility: Assessing recruitment, retention, adherence, and acceptability of the intervention.
2. Acceptability: Measuring the caregivers' satisfaction with the intervention using qualitative feedback and standard questionnaires.
3. Preliminary Efficacy: Evaluating the effect of the intervention on psychological adaptation (including depression, anxiety, and stress) and caregiver coping strategies.

Secondary outcomes will include improvements in caregiver burden, perceived social support, and the overall quality of life for both caregivers and children. Exploratory outcomes may include treatment adherence in children and changes in family dynamics.

Intervention Components:

The stage-matched intervention will consist of several key components tailored to the caregivers' needs at each phase of the treatment process:

1. Psychoeducation: Providing caregivers with information about the disease, treatment options, and coping strategies.
2. Emotional Validation: Helping caregivers process their emotions and understand the psychological effects of caregiving.
3. Problem-Solving Skills: Training caregivers in practical strategies for managing the daily challenges they face.
4. Dyadic Communication Support: Enhancing communication between caregivers and children, as well as between family members.
5. Social and Spiritual Resources: Linking caregivers with social support networks and spiritual guidance to strengthen their coping capacity.

The intervention will be delivered by trained mental health nurses under the supervision of a clinical psychologist. The content will be delivered through culturally appropriate methods, using verbal explanations, pictorial aids, and sessions in Urdu to ensure accessibility for caregivers with varying literacy levels.

Timeline:

The total duration of the study will be approximately 16 months:

• Stage 1 (Gap Definition) will take approximately 2 months.
• Stage 2 (Intervention Design) will occur from the 2nd to 6th month.
• Stage 3 (Model Refinement) will be conducted from the 6th to 8th month.
• Stage 4 (Pilot Trial) will take place from the 8th to 16th month.

Ethical Considerations:

Ethical approval has been obtained from the Ethics Review Board of Zhengzhou University, China (approval number: ZZUIRB2025-02) and the respective hospital administrations in Pakistan. Informed consent will be obtained from all participants, ensuring that they are fully aware of the study procedures, risks, and benefits.

Significance:

This study addresses a critical gap in supportive care for parent caregivers in low-resource settings, particularly in Pakistan, where psychosocial support services are limited. If successful, the intervention will provide an evidence-based, scalable tool for integration into routine oncology care. The results of this study will contribute valuable insights into the psychosocial needs of caregivers and how best to support them, ultimately improving both caregiver and child outcomes.

Inclusion Criteria:

• Parent caregiver (biological parent, step-parent, or legal guardian) primarily responsible for the daily care of a child diagnosed with leukemia.
• Child is receiving care at one of the participating pediatric oncology study facilities in Pakistan.
• Caregiver is aged 18 years or older.
• Caregiver is able to provide written informed consent.
• Caregiver is willing to participate in the 12-week study and complete study assessments.
• Caregiver is able to communicate in Urdu or another language used for study procedures at the participating site.

Exclusion Criteria:

• Parent caregiver plans to relocate outside the study area during the study period.
• Parent caregiver is not the primary caregiver of the child with leukemia.
• Parent caregiver is unable to provide informed consent.
• Parent caregiver has a severe cognitive, psychiatric, or medical condition that would prevent participation in the intervention or completion of study assessments, as judged by the study team.
• Parent caregiver is currently participating in another structured psychosocial intervention study that could interfere with this trial.

Individual Participant Data (IPD) will not be shared due to privacy concerns and the sensitive nature of the data collected in the study. The data involves personal health information, and the confidentiality of participants will be strictly maintained in accordance with ethical and legal requirements. Additionally, due to the study's specific context in pediatric oncology, data sharing is not currently planned