Feasibility Study of Family Teamwork Peer-Delivery

Type 1 Diabetes Clinical Trial

— TEAM  

Official title:

Feasibility Study of Family Teamwork Peer-Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053504
• Other study ID #: H-40380
• Secondary ID: DP3DK113236
• Status: Completed
• Phase: N/A
• Start date: May 4, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2022
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Primary caregiver of a child ages 5-10 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Acceptability: Treatment Evaluation Inventory	Treatment Evaluation Inventory	Immediately post-intervention
Primary	Study Enrollment Rate	Enrollment rate calculated from data obtained from recruitment logs	Pre-Randomization
Primary	Study Attrition Rate	Study attrition will be calculated from study logs	12 months
Primary	Monthly Intervention Calls Completed by Parent Leaders	Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs	12 months
Secondary	Change in Rate of Average Blood Glucose	Hemoglobin A1C from medical record	Change from baseline at 12 months
Secondary	Change in Frequency of Adherence	Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire	Change from baseline at 12 months
Secondary	Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module	Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life)	Change from baseline at 12 months
Secondary	Change in Level of Parent involvement in diabetes management tasks	The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management)	Change from baseline at 12 months
Secondary	Change in Level of Parent self-efficacy	Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy)	Change from baseline at 12 months
Secondary	Change in Level of Parent diabetes emotional burden	Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden)	Change from baseline at 12 months
Secondary	Change in Level of Parent Depressive Symptoms	The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms)	Change from baseline at 12 months
Secondary	Change in Level of Parent Social Support	2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support)	Change from baseline at 12 months
Secondary	Change in Degree of Impact of diabetes on the family system	Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family)	Change from baseline at 12 months

External Links

•   PI lab page