Development of a Stage Matched Psychosocial Intervention to Enhance Psychological Adaptation Among Parent Caregivers of Children With Leukemia in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Psychological Adaptation
研究概览
简要总结
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.
详细描述
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:
- Gap Definition (Stage 1): To identify the psychological adaptation gaps and caregiving challenges of parent caregivers through a systematic literature review and expert consultation.
- Intervention Design (Stage 2): To design a culturally relevant stage-matched psychosocial intervention based on the findings from the needs assessment and expert reviews.
- Model Refinement (Stage 3): To refine and finalize the intervention model based on feedback from focus groups and e-Delphi processes.
- Pilot Trial (Stage 4): To conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and preliminary efficacy of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stage-Matched Psychosocial Intervention
Parent caregivers in this arm will receive the stage-matched psychosocial intervention in addition to routine medical care over 12 weeks.
干预措施: Stage-Matched Psychosocial Intervention (Behavioral)
Stage-Matched Psychosocial Intervention
Parent caregivers in this arm will receive the stage-matched psychosocial intervention in addition to routine medical care over 12 weeks.
干预措施: Routine Medical Care (Other)
Routine Medical Care
Parent caregivers in this arm will receive routine medical care only.
结局指标
主要结局
Psychological Adaptation
时间窗: Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)
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.
Distress
时间窗: Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)
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).
Caregiver Burden
时间窗: Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)
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).
次要结局
未报告次要终点
研究者
Imtiaz Alam
PhD Scholar
Zhengzhou University