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

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ClinicalTrials.gov Identifier: NCT04606160
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
Children's Medical Center Dallas
Information provided by (Responsible Party):
Dennis Burchette, University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Single Session Problem-Solving Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Utilizing A Single Session Problem-Solving Intervention With Caregivers of Pediatric Patients Receiving Chronic Transfusion to Treat Sickle Cell Disease
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021


Arm Intervention/treatment
Experimental: Single Session Problem-Solving Intervention
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
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.

No Intervention: Control - Non Single Session Problem-Solving 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.



Primary Outcome Measures :
  1. Feasibility of utilizing the intervention as measured by the number of participants who are eligible and enroll in the study [ Time Frame: 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

  2. Feasibility of utilizing the intervention as measured by the number of participants who enrolled and were retained through Visit 4. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 3 [ Time Frame: Following the intervention to visit 3, approx. 1 month from the intervention ]

    Acceptability will be measured by the AARP (Abbreviated Acceptability Rating Profile) questionnaire.

    AARP created to be an abbreviated form of the Intervention Rating Profile (Witt & Elliott, 1985). The AARP (Tarnowski & Simonian, 1992) was developed as an eight-item measure that is rated on a 6-point Likert scale ranging from one (strongly disagree) to six (strongly agree). Higher scores represent higher acceptability of the intervention. The AARP has a Cronbach's alpha of .97 (Tarnowski & Simonian, 1992).


  2. Acceptability of the intervention as measured by the number of participants who find an intervention to be acceptable at visit 4 [ Time Frame: Following the intervention to visit 4, approx. 4 months from the intervention ]

    Acceptability will be measured by the AARP (Abbreviated Acceptability Rating Profile) questionnaire.

    AARP created to be an abbreviated form of the Intervention Rating Profile (Witt & Elliott, 1985). The AARP (Tarnowski & Simonian, 1992) was developed as an eight-item measure that is rated on a 6-point Likert scale ranging from one (strongly disagree) to six (strongly agree). Higher scores represent higher acceptability of the intervention. The AARP has a Cronbach's alpha of .97 (Tarnowski & Simonian, 1992).




Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient and Caregiver Participants:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606160


Contacts
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Contact: Dennis Burchette 214-456-1292 dennis.burchette@utsouthwestern.edu

Locations
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United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Jenna Oppenheim         
Principal Investigator: Dennis Burchette         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Investigators
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Principal Investigator: Dennis Burchette Doctoral Student Researcher
Study Chair: Jenna Oppenheim, PsyD Psychologist
Study Chair: Julie Germann, PhD Psychologist
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Responsible Party: Dennis Burchette, Doctoral Student, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04606160    
Other Study ID Numbers: STU-2020-0181
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data to be shared will be deidentified results of the study, including information about feasibility, acceptability, and efficacy data on use of a single session problem-solving intervention use with caregivers of pediatric patients receiving chronic transfusion to treat sickle cell disease.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will become available when published in journals to contribute to the literature.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dennis Burchette, University of Texas Southwestern Medical Center:
sickle cell disease
chronic transfusion
problem solving
single session intervention
children
pediatrics
pediatric patients
caregivers
scd
intervention
chronic blood transfusion
hematology
sickle cell
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn