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Feasibility Study of Family Teamwork Peer-Delivery (TEAM)

Baylor College of Medicine logo

Baylor College of Medicine

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Behavioral: Family Teamwork-Peer Delivery

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04053504
DP3DK113236 (U.S. NIH Grant/Contract)
H-40380

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intervention
Experimental group
Description:
Behavioral intervention delivered by parent peer leaders.
Treatment:
Behavioral: Family Teamwork-Peer Delivery
Standard Care
No Intervention group
Description:
Standard diabetes care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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