Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT04606160
Brief Summary:
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.
Detailed Description:
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.
Aims and Hypotheses
Aim 1: Determine the feasibility of utilizing a single-session problem solving intervention.
Hypothesis 1: At least 70% of participants approached for this study will agree to enroll.
Hypothesis 2: At least 70% of participants who start the study will be retained through V4.
Aim 2: Determine the acceptability of a single-session problem solving intervention.
Hypothesis 3: At least 70% of caregivers will find the single-session intervention to be acceptable at V3.
Hypothesis 4: At least 70% of caregivers will find the single-session intervention to be acceptable at V4.
Aim 3: Determine the efficacy of a single-session problem solving intervention at improving the selected problem.
Hypothesis 5: The intervention group will report a greater decrease in difficulty associated with their identified problem \[Psychosocial Outcomes Profiles (PSYCHLOPS)\] over time (V3 and V4) compared to those in the control group.
Hypothesis 6: The intervention group will report a greater decrease in psychosocial risk factor score \[Psychosocial Assessment Tool (PAT)\] over time as compared to the control group.
Hypothesis 7: The intervention group will report a greater increase in quality of life \[Pediatrics Quality of Life\_ Sickle Cell Disease Module (PedsQL\_SCD Module)\], both patient and caregiver report) over time as compared to the control group.
Study:
NCT04606160
Study Brief:
Protocol Section:
NCT04606160