Feasibility Study of Family Teamwork Peer-Delivery (TEAM)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Family Teamwork-Peer Delivery

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability: Treatment Evaluation Inventory	Treatment Evaluation Inventory	Immediately post-intervention
Study Enrollment Rate	Enrollment rate calculated from data obtained from recruitment logs	Pre-Randomization
Study Attrition Rate	Study attrition will be calculated from study logs	12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rate of Average Blood Glucose	Hemoglobin A1C from medical record	Change from baseline at 12 months
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ashley M Butler, PhD, Baylor College of Medicine

Publications and helpful links

Helpful Links

• PI lab page

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2019
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Health disparities; Community-based intervention; Family teamwork; Peer-delivered intervention; Facilitators to diabetes management; Barriers to diabetes management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: H-40380; DP3DK113236 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No