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Feasibility Study of Family Teamwork Peer-Delivery (TEAM)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Teamwork-Peer Delivery
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Health disparities, Family teamwork, Peer-delivered intervention, Facilitators to diabetes management, Barriers to diabetes management, Community-based intervention

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard Care

Arm Description

Behavioral intervention delivered by parent peer leaders.

Standard diabetes care

Outcomes

Primary Outcome Measures

Intervention Acceptability: Treatment Evaluation Inventory
Treatment Evaluation Inventory
Study Enrollment Rate
Enrollment rate calculated from data obtained from recruitment logs
Study Attrition Rate
Study attrition will be calculated from study logs
Monthly Intervention Calls Completed by Parent Leaders
Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs

Secondary Outcome Measures

Change in Rate of Average Blood Glucose
Hemoglobin A1C from medical record
Change in Frequency of Adherence
Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire
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 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 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 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 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 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 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)

Full Information

First Posted
July 8, 2019
Last Updated
July 22, 2022
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04053504
Brief Title
Feasibility Study of Family Teamwork Peer-Delivery
Acronym
TEAM
Official Title
Feasibility Study of Family Teamwork Peer-Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Health disparities, Family teamwork, Peer-delivered intervention, Facilitators to diabetes management, Barriers to diabetes management, Community-based intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Behavioral intervention delivered by parent peer leaders.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard diabetes care
Intervention Type
Behavioral
Intervention Name(s)
Family Teamwork-Peer Delivery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention Acceptability: Treatment Evaluation Inventory
Description
Treatment Evaluation Inventory
Time Frame
Immediately post-intervention
Title
Study Enrollment Rate
Description
Enrollment rate calculated from data obtained from recruitment logs
Time Frame
Pre-Randomization
Title
Study Attrition Rate
Description
Study attrition will be calculated from study logs
Time Frame
12 months
Title
Monthly Intervention Calls Completed by Parent Leaders
Description
Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Rate of Average Blood Glucose
Description
Hemoglobin A1C from medical record
Time Frame
Change from baseline at 12 months
Title
Change in Frequency of Adherence
Description
Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire
Time Frame
Change from baseline at 12 months
Title
Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module
Description
Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life)
Time Frame
Change from baseline at 12 months
Title
Change in Level of Parent involvement in diabetes management tasks
Description
The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management)
Time Frame
Change from baseline at 12 months
Title
Change in Level of Parent self-efficacy
Description
Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy)
Time Frame
Change from baseline at 12 months
Title
Change in Level of Parent diabetes emotional burden
Description
Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden)
Time Frame
Change from baseline at 12 months
Title
Change in Level of Parent Depressive Symptoms
Description
The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms)
Time Frame
Change from baseline at 12 months
Title
Change in Level of Parent Social Support
Description
2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support)
Time Frame
Change from baseline at 12 months
Title
Change in Degree of Impact of diabetes on the family system
Description
Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family)
Time Frame
Change from baseline at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley M Butler, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.bcm.edu/departments/pediatrics/sections-divisions-centers/psychology/research/health-disparities-laboratory
Description
PI lab page

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Feasibility Study of Family Teamwork Peer-Delivery

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