Utilizing A Single Session Problem-Solving Intervention With Caregivers of Pediatric Patients Receiving Chronic Transfusion to Treat Sickle Cell Disease

NCT04606160 | Completed

• 1 other identifier: STU-2020-0181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; chronic transfusion; problem solving; single session intervention; children; pediatrics; pediatric patients; caregivers; scd; intervention; chronic blood transfusion; hematology; sickle cell

Outcome Measures

Primary Outcomes (2)

• Feasibility of utilizing the intervention as measured by the number of participants who are eligible and enroll in the study

  Feasibility of utilizing the intervention will be measured by counting the number of participants who meet the eligibility criteria and enroll in the study

  Time of enrollment, approx. 2-3 days from initial recruitment attempt

• Feasibility of utilizing the intervention as measured by the number of participants who enrolled and were retained through Visit 4.

  Feasibility of utilizing the intervention as measured by counting the number of participants who enrolled and were retained through Visit 4.

  Time of enrollment until completion of study, approx. 12 months

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Single Session Problem-Solving Intervention

EXPERIMENTAL

Participants will receive a single session problem-solving intervention during visit 2 of the 4 visit research study. During visit 3, participants will receive a review of the intervention from visit 2. During visits 1, 3, and 4, participants will complete measures.

Behavioral: Single Session Problem-Solving Intervention

Control - Non Single Session Problem-Solving Intervention

NO INTERVENTION

These participants will complete measures at visits 1,2,3, and 4. They will also receive a visit during visit 2 of the 4 visit study, where they will only complete measures.

Interventions

Single Session Problem-Solving Intervention BEHAVIORAL

The intervention will be a researcher led 30-45 minute session using the problem-solving module from the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Issues (MATCH-ADTC protocol.

Single Session Problem-Solving Intervention

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Medical Center Dallas: collaborator

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dennis Burchette

  Doctoral Student Researcher

  PRINCIPAL INVESTIGATOR

• Jenna Oppenheim, PsyD

  Psychologist

  STUDY CHAIR

• Julie Germann, PhD

  Psychologist

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: December 9, 2020
• Primary Completion: January 4, 2022
• Study Completion: February 1, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will become available when published in journals to contribute to the literature.

Locations

US (1)