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Utilizing A Single Session Problem-Solving Intervention with Caregivers of Pediatric Patients Receiving Chronic Transfusion to Treat Sickle Cell Disease
Study ID: STU-2020-0181
Summary
The study will be a randomized controlled trial of a single-session problem-solving intervention with caregivers of patients with sickle cell disease who are receiving chronic blood transfusions. Study procedures will either take place during routine transfusion clinic visits or during a seperate visit with the researcher, outside of the scheduled chronic transfusion visit. if study is conducted in-person: at visit one (V1), both study groups (intervention and control) will be consented through ReDCap, and receive a baseline visit, which will include completion of measures (Quality of Life and Psychosocial assessment Tool) via ReDCap. To address possible literacy issues, study personnel will offer participants the option to have questions read to them. at V1, participants will be provided a list community mental health resources, via handout or email, to have for future reference if mental health needs arise. Before visit 2 (V2), participant pairs (including one caregiver and one patient) will be randomized into one of two study arms - the control group or the intervention group (n[?]25 each). Group assignment will be determined randomly, generated through computer software. During visit two (V2), (typically occurs 1 month after V1) the intervention Group will complete the PSYCHLoPS (psychological outcomes profiles) 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 (for a description of the measures, see section 4a below). Problems to be solved will be identified by the family from a list of pre-selected domains, based on measures completed during visit one. The Control Group will receive a visit from the researcher in which the caregiver participant will complete the PSYCHLoPS measure. at visit three (V3), (typically occurs 2 months after V1), both groups (intervention and control) will complete the same measures from V1 with the addition of all Caregiver participants completing the PSYCHLoPS measure. at this visit, the 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 also complete the abbreviated acceptability Ratings Profile (aaRP) at the end of the intervention review. at visit four (V4), (typically occurs 5 months after V1) both groups (intervention and control) will complete the same measures as in V1, and the PSYCHLoPS measure, for longer-term follow up. in addition, the intervention Group will complete the aaRP. Throughout this study, the researcher will notify the clinical psychologist to address mental health needs, should high level needs arise. Virtual alternatives for all study visits: all study procedures will remain the same as stated above, except: Participants will be contacted via a Children's Health approved telehealth service or phone call to be informed about the study, for recruitment purposes. * all study visits will be completed virtually through a Children's Health approved telehealth service. * a copy of community mental health resources may be emailed to participants, or clinic staff will provide a handout of community mental health resources to participants. * a copy of the consent form may be emailed to participants, or clinic staff will provide a hardcopy to participants. * To provide ease of access for participation, a ReDCap link to complete consent and research measures may be emailed to participants or clinic staff will provide an iPad to participants in clinic to complete consent and research measures.
- Cancer Related
- No
- Healthy Volunteers
- Yes
- UT Southwestern Principal Investigator
- DENNIS DELAINE BURCHETTE
UNIVERSITY OF TEXAS SOUTHWESTERN
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. Patients with sickle cell disease deserve access to high quality services that address the psychosocial factors often impacting their clinical outcomes. it is rare that psychological services are conveniently accessible at the same time as medical appointments. The ability to participate in psychological services will make a difference in providing tools necessary to promote effective problem-solving techniques and incorporation into everyday life. This study seeks to investigate the feasibility and efficacy of utilizing a single-session problem-solving intervention to address problems affecting children and families receiving chronic transfusions for sickle cell disease in order to: 1) contribute to literature related to single session problem solving interventions wit[See protocol for complete text]