Insul-In This Together: Leveraging Family Support and Diabetes Technology for Adolescents Living With Type 1 Diabetes (IITT)
The goal of this clinical trial is to learn if the "Insul-In This Together" family program works to improve outcomes for adolescents living with type 1 diabetes. It will also learn about how the program influences diabetes-related factors, including parenting. The main questions it aims to answer are:
Does this program improve glycemic (blood glucose) outcomes? Does this program improve adolescent quality of life related to diabetes? Researchers will offer the program to all participating families, with one group receiving the program right after enrollment and another group receiving the program 6 months later.
Adolescent and parent participants will:
Attend 8 weekly 30-minute videoconference sessions with an interventionist Complete online surveys, share diabetes device data, and conduct at-home A1c tests 3-5 times over a 12-month period
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The proposed study is a nationwide randomized controlled trial with 200 adolescents ages 12-17 living with type 1 diabetes for at least six months who are US residents and their parents. Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up). The primary outcome endpoint will be 3-month post-baseline, based on prior findings. This cross-over design will support recruitment and retention and offer all participants the opportunity to receive this empirically supported program, while maintaining an experimental comparison group. The revised intervention includes eight 30-minute weekly sessions to be delivered to each parent-adolescent dyad by a trained interventionist. Didactic and interactive content targets parental monitoring, involvement strategies, collaborative problem-solving, and communication across six sessions with two glycemic sessions that focus on glucose monitoring, data interpretation, and strategies to increase/optimize technology use. Data will be gathered via adolescent and parent report, continuous glucose monitoring (CGM) and other device data, and at-home HbA1c test kits. We will assess intervention outcomes, differential intervention responses, and key drivers of change.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jessie J Wong, PhD
- Telefoonnummer: 6507361517
- E-mail: wongjj@stanford.edu
Studie Locaties
-
-
California
-
Palo Alto, California, Verenigde Staten, 94305
- Stanford University
-
Contact:
- Jessie J Wong, PhD
- Telefoonnummer: 6507361517
- E-mail: wongjj@stanford.edu
-
Hoofdonderzoeker:
- Jessie J Wong, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- For adolescent participants: ages 12-17, diagnosed with type 1 diabetes for at least 6 months, US resident, English proficiency, and resides with the participating parent/caregiver.
- For parent participants: residing with eligible and participating adolescent, US resident, and English proficiency.
Exclusion Criteria:
- Severe or pervasive physical or mental health condition that would limit participation in data collection or the intervention (e.g., pervasive developmental delays).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intervention
Offered the intervention immediately after Baseline data collection |
The "Insul-In This Together" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent/caregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use. |
|
Ander: Waitlisted Control
Offered the intervention after 6-Month Post-Baseline data collection |
The "Insul-In This Together" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent/caregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adolescent diabetes-related quality of life
Tijdsspanne: From Baseline (post enrollment) to 12-month post-baseline
|
The Type 1 Diabetes and Life (T1DAL) survey is a 23-item scale with a teen version (ages 12-17) and a young adult version (ages 18-25) that capture quality of life related to living with diabetes (for those who turn 18 during the study). |
From Baseline (post enrollment) to 12-month post-baseline
|
|
Percent time-in-range (TIR)
Tijdsspanne: From baseline (post enrollment) to 12-month post-baseline
|
TIR is strongly linked to risk of health complications and offers valuable insights beyond hemoglobin A1c, particularly.13 Percent time spent in target range (70-180mg/dL) will be calculated based on continuous glucose monitoring (CGM) data captured in a 14-day window. At least 10 days of data will be required within the 14-day window to be included in analyses. |
From baseline (post enrollment) to 12-month post-baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hemoglobin A1c
Tijdsspanne: From baseline (post enrollment) to 12-month post-baseline
|
HbA1c results will be gathered based on at-home test kits provided and analyzed by University of Minnesota. |
From baseline (post enrollment) to 12-month post-baseline
|
|
Adolescent diabetes distress
Tijdsspanne: From baseline (post enrollment) to 12-month post-baseline
|
The Problem Areas in Diabetes questionnaire (PAID) is a 20-item scale of emotional responses related to diabetes distress among adolescents. |
From baseline (post enrollment) to 12-month post-baseline
|
|
Parent diabetes distress
Tijdsspanne: From Baseline (post enrollment) to 12-month post-baseline
|
The Parent Diabetes Distress Scale (P-DDS) is a 20-item measure of diabetes related distress among parents of teens with diabetes. |
From Baseline (post enrollment) to 12-month post-baseline
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 88772
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary results. Requests will be reviewed by the study team and will require a scientifically sound proposal, institutional approvals as applicable, and a data use agreement that prohibits re-identification or onward sharing. Data sharing will be limited to information that can be provided without compromising participant privacy or confidentiality.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .