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Feasibility Study of Family Teamwork Peer-Delivery (TEAM)

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ClinicalTrials.gov Identifier: NCT04053504
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Texas Children's Hospital
Information provided by (Responsible Party):
Ashley Butler, Baylor College of Medicine

Brief Summary:

The purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D.

A randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Family Teamwork-Peer Delivery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Family Teamwork Peer-Delivery
Actual Study Start Date : May 4, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Behavioral intervention delivered by parent peer leaders.
Behavioral: Family Teamwork-Peer Delivery
Children with T1D and their parent will participate in 6 in-person FT-P group sessions during a 12-month period. Parents will also participate in monthly telephone support calls with a Parent Leader during the 12-month intervention period.

No Intervention: Standard Care
Standard diabetes care



Primary Outcome Measures :
  1. Intervention Acceptability: Treatment Evaluation Inventory [ Time Frame: Immediately post-intervention ]
    Treatment Evaluation Inventory

  2. Study Enrollment Rate [ Time Frame: Pre-Randomization ]
    Enrollment rate calculated from data obtained from recruitment logs

  3. Study Attrition Rate [ Time Frame: 12 months ]
    Study attrition will be calculated from study logs

  4. Monthly Intervention Calls Completed by Parent Leaders [ Time Frame: 12 months ]
    Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs


Secondary Outcome Measures :
  1. Change in Rate of Average Blood Glucose [ Time Frame: Change from baseline at 12 months ]
    Hemoglobin A1C from medical record

  2. Change in Frequency of Adherence [ Time Frame: Change from baseline at 12 months ]
    Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire

  3. Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module [ Time Frame: Change from baseline at 12 months ]
    Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life)

  4. Change in Level of Parent involvement in diabetes management tasks [ Time Frame: Change from baseline at 12 months ]
    The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management)

  5. Change in Level of Parent self-efficacy [ Time Frame: Change from baseline at 12 months ]
    Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy)

  6. Change in Level of Parent diabetes emotional burden [ Time Frame: Change from baseline at 12 months ]
    Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden)

  7. Change in Level of Parent Depressive Symptoms [ Time Frame: Change from baseline at 12 months ]
    The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms)

  8. Change in Level of Parent Social Support [ Time Frame: Change from baseline at 12 months ]
    2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support)

  9. Change in Degree of Impact of diabetes on the family system [ Time Frame: Change from baseline at 12 months ]
    Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family)



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary caregiver of a child ages 5-9 years with type 1 diabetes as defined by the American Diabetes Association criteria
  • Having a child with diabetes duration of >1 year
  • Self-identified African American or Latino race/ethnicity
  • Fluent in English
  • Not planning to leave the geographic area during the study

Exclusion Criterion:

• Not fluent in English


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): NCT04053504


Contacts
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Contact: Ashley M Butler, PhD 832-822-4899 ambutler@bcm.tmc.edu

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ashley M Butler, PhD    832-822-4899    ambutler@bcm.tmc.edu   
Principal Investigator: Ashley M Butler, PhD         
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Texas Children's Hospital
Investigators
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Principal Investigator: Ashley M Butler, PhD Baylor College of Medicine

Additional Information:
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Responsible Party: Ashley Butler, Associate Professor, Pediatrics-Psychology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04053504     History of Changes
Other Study ID Numbers: H-40380
DP3DK113236 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Ashley Butler, Baylor College of Medicine:
Health disparities
Family teamwork
Peer-delivered intervention
Facilitators to diabetes management
Barriers to diabetes management
Community-based intervention

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases