Utilizing A Single Session Problem-Solving Intervention With Caregivers of Pediatric Patients Receiving Chronic Transfusion to Treat Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of utilizing the intervention as measured by the number of participants who enrolled and were retained through Visit 4.
研究概览
简要总结
This study seeks to utilize an innovative approach of a single session problem-solving intervention to address psychosocial factors affecting patient outcomes within the pediatric sickle cell population. The study will be a randomized control trial of a single session problem-solving intervention.
This original research will investigate the feasibility and efficacy of utilizing a single-session problem-solving intervention to address problems affecting children and families receiving chronic blood transfusions for sickle cell disease in order to: 1) contribute to literature related to single session problem solving interventions with the chronic transfusion sickle cell population and 2) identify a model of sustainable care that reduces the burden of a multiple session intervention and increases access to services. Additionally, this research aims to provide relatively low burden and potentially highly effective intervention into regular care for this population in order to evaluate the feasibility of integrating a single-session problem solving intervention into routine clinical flow, thereby addressing needs more systematically that have been identified by families. Further, this research aims to identify potential utility of medical providers being trained on providing the intervention, which could be part of a future study.
详细描述
In the event that research must be completed virtually due to coronavirus (COVID-19) restrictions at the research site, an Ipad will be provided to participants by clinic staff to complete measures, through Research Electronic Data Capture (REDCap) and the intervention/control visits through a Children's Health-approved and HIPAA compliant telehealth platform. Due to continued changes in protocols, it is possible that participants may begin with in-person research and transition to virtual research, or vice versa.
Patient list for chronic blood transfusion clinic will be reviewed weekly for eligible participants. Eligible participants will be approached at the start of their routine blood transfusion (which are part of their clinical care) appointment to minimize interference from sedative medications. The researcher will explain the study and answer questions related to participation. If the caregiver and youth choose to participate, written consent (and patient assent when appropriate) will be obtained.
At visit one, both study groups will receive a baseline visit (V1), which will include completing measures, and participants will be provided a handout of community mental health resources to have for future reference if mental health needs arise. During visit two (V2), (typically occurs approximately 1 month after V1) caregivers in the intervention group will complete the Psychological Outcomes Profiles (PSYCHLOPS) measure, receive a single session problem-solving intervention to target an identified problem, and complete the Abbreviated Acceptability Rating Profile (AARP) at the end of the intervention. Problem to be targeted will be identified collaboratively by the researcher and the caregiver, after review of measures completed by the caregiver and youth participant during visit one. The control group will receive a visit from the researcher, in which the caregiver participant will complete the PSYCHLOPS measure. During visit three (V3), (typically occurs approximately 2 months after V1), both groups will complete the same measures from visit one, with the addition of all caregiver participants completing the PSYCLOPS measure. At this visit, caregivers in the intervention group will also receive a short review of the problem-solving strategy and address questions about the skill following completion of measures. The caregiver participants in the intervention group will complete the AARP at the end of the intervention review. At visit four (V4), (typically occurs approximately five months after V1) both groups will complete the same measures as visit one, in addition to the PSYCHLOPS measure, for longer-term follow up. In addition, the intervention group will complete the AARP.
Virtual alternative for all visits:
All study procedures will remain the same as stated above, except clinic staff will provide the handout of community mental health resources to participants and visits with both the Intervention Group and Control Group will be conducted through a Children's Health-approved telehealth platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Patient and/or caregiver of patient between the ages of 7 years to less than 19 at time of enrollment
- •Patient and/or caregiver of patient diagnosis of sickle cell disease with sickle cell - SS genotype
- •Patient and/or caregiver of patient who has received chronic blood transfusions for at least 6 months and continuing through the duration of the study
- •Caregiver and patient pair agree to both participate in the study
排除标准
- •Patient or caregiver of patient who are temporarily on blood transfusions for a transient complication (e.g., priapism or recurrent acute chest syndrome)
- •Patient and/or caregiver of patient displaying clinically evident cognitive delay (e.g., stroke with severe cognitive deficits, intellectual disability) that would preclude completion of measures or participation in intervention as defined by the medical team, researcher, or psychologist.
- •Patient and/or caregiver of patient who is a ward of state
结局指标
主要结局
Feasibility of utilizing the intervention as measured by the number of participants who enrolled and were retained through Visit 4.
时间窗: Time of enrollment until completion of study, approx. 12 months
Feasibility of utilizing the intervention as measured by counting the number of participants who enrolled and were retained through Visit 4.
Feasibility of utilizing the intervention as measured by the number of participants who are eligible and enroll in the study
时间窗: Time of enrollment, approx. 2-3 days from initial recruitment attempt
Feasibility of utilizing the intervention will be measured by counting the number of participants who meet the eligibility criteria and enroll in the study
次要结局
- Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 4(Following the intervention to visit 4, approx. 4 months from the intervention)
- Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 3(Following the intervention to visit 3, approx. 1 month from the intervention)
研究者
Dennis Burchette
Doctoral Student
University of Texas Southwestern Medical Center