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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
88
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.
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.
Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, Pakistan
Psychological Adaptation
The primary outcome measure will assess the psychological adaptation of parent caregivers of children with leukemia. It will be measured using validated scales such as the Psychological Adaptation Scale (PAS), which evaluates the caregiver's emotional response to their child's illness, their coping strategies, and overall psychological adjustment.The scale contains 20 items and 4 dimensions, namely coping ability, self-reliance, social ability and psychological growth. The scale uses the Likert 5-point scoring method, 1 represents strongly disagree and 5 represents strongly agree. The higher the score, the better the psychological adaptation of the caregiver.
Time frame: Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)
Distress
The level of emotional distress (including depression, anxiety, and stress) will be assessed using the DASS-21 (Depression, Anxiety, Stress Scale). The scale will measure the severity of distress experienced by parent caregivers during the intervention period.This scale consists 21 items, with 7 items per for each of the three scales. For reporting the score of the three scales Depression ( Normal 0-9, Mild 5-6, Moderate 7-10, Sever 11-13 and Extremely severe 14+), Anxiety ( Normal 0-3, Mild 4-5, Moderate 6-7, Sever 8-9 and Extremely severe 10+) and Stress ( Normal 0-7, Mild 8-9, Moderate 10-12, Sever 13-16 and Extremely severe 17+).Higher scores on the DASS-21 indicate worse outcomes (i.e., higher levels of distress, including depression, anxiety, and stress).
Time frame: Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)
Caregiver Burden
The Caregiver Burden Scale will be used to assess the burden felt by caregivers in terms of time, physical, emotional, and financial strain due to caregiving responsibilities.It contained 22 items assessing experience of burden. The total score is 88 and for reporting the scale is: No or minimal burden ( 0-20) , Mild to moderate burden (21-40), Moderate to severe burden ( 41-60) and severe burden (61-88). Higher scores on the Caregiver Burden Scale indicate worse outcomes (i.e., higher levels of burden or strain experienced by the caregiver).
Time frame: Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.