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Completed

NCT Number: NCT04053504

Feasibility Study of Family Teamwork Peer-Delivery

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Teamwork-Peer Delivery

Behavioral

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 outcomes

  1. Intervention Acceptability: Treatment Evaluation Inventory

    Time frame: Immediately post-intervention

    Treatment Evaluation Inventory

  2. Study Enrollment Rate

    Time frame: Pre-Randomization

    Enrollment rate calculated from data obtained from recruitment logs

  3. Study Attrition Rate

    Time frame: 12 months

    Study attrition will be calculated from study logs

  4. Monthly Intervention Calls Completed by Parent Leaders

    Time frame: 12 months

    Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs

Secondary outcomes

  1. Change in Rate of Average Blood Glucose

    Time frame: Change from baseline at 12 months

    Hemoglobin A1C from medical record

  2. Change in Frequency of Adherence

    Time frame: Change from baseline at 12 months

    Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire

  3. Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module

    Time frame: Change from baseline at 12 months

    Pediatric Quality of Life Total Cumulative Scale (scores range from 0-132 with higher scores indicating worse quality of life)

  4. Change in Level of Parent involvement in diabetes management tasks

    Time frame: Change from baseline at 12 months

    The Diabetes Family Responsibility Questionnaire (scores range from 17-51 with lower scores indicating parent in primarily responsible for diabetes management)

  5. Change in Level of Parent self-efficacy

    Time frame: Change from baseline at 12 months

    Parental Self-Efficacy for Diabetes Management questionnaire scores range from 8-40 with higher scores indicating higher self-efficacy)

  6. Change in Level of Parent diabetes emotional burden

    Time frame: Change from baseline at 12 months

    Problem Areas in Diabetes Revised for Parents (scores range from 0-72 with higher scores indicating less emotional burden)

  7. Change in Level of Parent Depressive Symptoms

    Time frame: Change from baseline at 12 months

    The Center for Epidemiological Depression Studies-Depression scale (scores range from 12-48 with higher scores indicating more depressive symptoms)

  8. Change in Level of Parent Social Support

    Time frame: Change from baseline at 12 months

    2-way Social Support Scale total score (scores range from 0-100 with higher scores indicating more giving and receiving of social support)

  9. Change in Degree of Impact of diabetes on the family system

    Time frame: Change from baseline at 12 months

    Diabetes Family Impact Scale (scores range from 0-56 with higher scores indicating greater impact of diabetes on the family)

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: TEAM

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 12, 2019
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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