Clinical trial NCT04053504: Feasibility Study of Family Teamwork Peer-Delivery
Official title: Feasibility Study of Family Teamwork Peer-Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Health disparities
Family teamwork
Peer-delivered intervention
Facilitators to diabetes management
Barriers to diabetes management
Community-based intervention
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Intervention Acceptability: Treatment Evaluation Inventory
timeFrame: Immediately post-intervention
measure: Study Enrollment Rate
timeFrame: Pre-Randomization
measure: Study Attrition Rate
timeFrame: 12 months
measure: Monthly Intervention Calls Completed by Parent Leaders
timeFrame: 12 months
Secondary outcomes:
measure: Change in Rate of Average Blood Glucose
timeFrame: Change from baseline at 12 months
measure: Change in Frequency of Adherence
timeFrame: Change from baseline at 12 months
measure: Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module
timeFrame: Change from baseline at 12 months
measure: Change in Level of Parent involvement in diabetes management tasks
timeFrame: Change from baseline at 12 months
measure: Change in Level of Parent self-efficacy
timeFrame: Change from baseline at 12 months
measure: Change in Level of Parent diabetes emotional burden
timeFrame: Change from baseline at 12 months
measure: Change in Level of Parent Depressive Symptoms
timeFrame: Change from baseline at 12 months
measure: Change in Level of Parent Social Support
timeFrame: Change from baseline at 12 months
measure: Change in Degree of Impact of diabetes on the family system
timeFrame: Change from baseline at 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Ashley M Butler, PhD
role: PRINCIPAL_INVESTIGATOR
References: