Feasibility Study of Family Teamwork Peer-Delivery (TEAM)
22. juli 2022 opdateret af: Ashley Butler, Baylor College of Medicine
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Texas Children's Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 10 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Behavioral intervention delivered by parent peer leaders.
|
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.
|
|
Ingen indgriben: Standard Care
Standard diabetes care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention Acceptability: Treatment Evaluation Inventory
Tidsramme: Immediately post-intervention
|
Treatment Evaluation Inventory
|
Immediately post-intervention
|
|
Study Enrollment Rate
Tidsramme: Pre-Randomization
|
Enrollment rate calculated from data obtained from recruitment logs
|
Pre-Randomization
|
|
Study Attrition Rate
Tidsramme: 12 months
|
Study attrition will be calculated from study logs
|
12 months
|
|
Monthly Intervention Calls Completed by Parent Leaders
Tidsramme: 12 months
|
Percentage of monthly intervention calls completed by Parent Leaders will be determined from study logs
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Rate of Average Blood Glucose
Tidsramme: Change from baseline at 12 months
|
Hemoglobin A1C from medical record
|
Change from baseline at 12 months
|
|
Change in Frequency of Adherence
Tidsramme: Change from baseline at 12 months
|
Frequency of blood glucose monitoring obtained from blood glucose meter and the Diabetes Self-Management Questionnaire
|
Change from baseline at 12 months
|
|
Change in Level of Child Diabetes Quality of Life: Pediatric Quality of Life Diabetes Module
Tidsramme: 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)
|
Change from baseline at 12 months
|
|
Change in Level of Parent involvement in diabetes management tasks
Tidsramme: 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)
|
Change from baseline at 12 months
|
|
Change in Level of Parent self-efficacy
Tidsramme: 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)
|
Change from baseline at 12 months
|
|
Change in Level of Parent diabetes emotional burden
Tidsramme: 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)
|
Change from baseline at 12 months
|
|
Change in Level of Parent Depressive Symptoms
Tidsramme: 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)
|
Change from baseline at 12 months
|
|
Change in Level of Parent Social Support
Tidsramme: 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)
|
Change from baseline at 12 months
|
|
Change in Degree of Impact of diabetes on the family system
Tidsramme: 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)
|
Change from baseline at 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ashley M Butler, PhD, Baylor College of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. maj 2019
Primær færdiggørelse (Faktiske)
30. maj 2021
Studieafslutning (Faktiske)
1. maj 2022
Datoer for studieregistrering
Først indsendt
8. juli 2019
Først indsendt, der opfyldte QC-kriterier
8. august 2019
Først opslået (Faktiske)
12. august 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-40380
- DP3DK113236 (U.S. NIH-bevilling/kontrakt)
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