Type 1 DiabetesTEAMNCT04053504
Feasibility Study of Family Teamwork Peer-Delivery
A study testing Family Teamwork-Peer Delivery in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Family Teamwork-Peer Delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Family Teamwork-Peer Delivery
- Keywords
- Health disparities, Family teamwork, Peer-delivered intervention, Facilitators to diabetes management, Barriers to diabetes management, Community-based intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Teamwork-Peer DeliveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral intervention delivered by parent peer leaders. Receives: Behavioral: Family Teamwork-Peer Delivery |
| Standard Care | No intervention | Standard diabetes care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability: Treatment Evaluation Inventory
Treatment Evaluation Inventory
Measured: Immediately post-intervention
Study Enrollment Rate
Enrollment rate calculated from data obtained from recruitment logs
Measured: Pre-Randomization
Study Attrition Rate
Study attrition will be calculated from study logs
Measured: 12 months
Monthly Intervention Calls Completed by Parent Leaders
Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs
Measured: 12 months
Secondary outcomes (9)
Change in Rate of Average Blood Glucose
Hemoglobin A1C from medical record
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start4 May 2019
- Primary completion30 May 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Butler, Baylor College of Medicine
- Investigators
- Ashley M Butler, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053504
- Sponsor's protocol ID
- H-40380
- Other IDs
- DP3DK113236
- Acronym
- TEAM
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2019
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Butler AM, Hilliard ME, Christopher K, Baudino M, Minard C, Karaviti L. Feasibility and acceptability of the TEAM pilot trial with African American and Latino families. J Pediatr Psychol. 2025 May 1;50(5):388-398. doi: 10.1093/jpepsy/jsaf001.
PubMed 40139919
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Family Teamwork Peer-Delivery
- ClinicalTrials.gov ID
- NCT04053504
- Acronym / sponsor ID
- TEAM / H-40380
- Conditions
- Type 1 Diabetes
- Keywords
- Health disparities, Family teamwork, Peer-delivered intervention, Facilitators to diabetes management, Barriers to diabetes management, Community-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 May 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family Teamwork-Peer DeliveryBehavioral intervention delivered by parent peer leaders. |
| Standard Care | No intervention | –Standard diabetes care |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Teamwork-Peer DeliveryChildren 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. | Behavioural | Intervention |
Primary outcome
Intervention Acceptability: Treatment Evaluation Inventory
Time frame: Immediately post-intervention
Treatment Evaluation Inventory
Study Enrollment Rate
Time frame: Pre-Randomization
Enrollment rate calculated from data obtained from recruitment logs
Study Attrition Rate
Time frame: 12 months
Study attrition will be calculated from study logs
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
9 secondary outcomes
Change in Rate of Average Blood Glucose
Time frame: Change from baseline at 12 months
Change in Frequency of Adherence
Time frame: Change from baseline at 12 months
Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module
Time frame: Change from baseline at 12 months
Change in Level of Parent involvement in diabetes management tasks
Time frame: Change from baseline at 12 months
Change in Level of Parent self-efficacy
Time frame: Change from baseline at 12 months
Change in Level of Parent diabetes emotional burden
Time frame: Change from baseline at 12 months
Change in Level of Parent Depressive Symptoms
Time frame: Change from baseline at 12 months
Change in Level of Parent Social Support
Time frame: Change from baseline at 12 months
Change in Degree of Impact of diabetes on the family system
Time frame: Change from baseline at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 40139919Butler AM, Hilliard ME, Christopher K, Baudino M, Minard C, Karaviti L. Feasibility and acceptability of the TEAM pilot trial with African American and Latino families. J Pediatr Psychol. 2025 May 1;50(5):388-398. doi: 10.1093/jpepsy/jsaf001.
- PI lab pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley M Butler, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Teamwork-Peer Delivery in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability: Treatment Evaluation Inventory (time frame: Immediately post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.