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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jessie J Wong, PhD
- 전화번호: 6507361517
- 이메일: wongjj@stanford.edu
연구 장소
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California
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Palo Alto, California, 미국, 94305
- Stanford University
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연락하다:
- Jessie J Wong, PhD
- 전화번호: 6507361517
- 이메일: wongjj@stanford.edu
-
수석 연구원:
- Jessie J Wong, PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
다른: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adolescent diabetes-related quality of life
기간: From Baseline (post enrollment) to 12-month post-baseline
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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
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Percent time-in-range (TIR)
기간: From baseline (post enrollment) to 12-month post-baseline
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemoglobin A1c
기간: From baseline (post enrollment) to 12-month post-baseline
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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
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Adolescent diabetes distress
기간: From baseline (post enrollment) to 12-month post-baseline
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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
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Parent diabetes distress
기간: From Baseline (post enrollment) to 12-month post-baseline
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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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 88772
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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