- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00890331
Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Family Teamwork and Coping Skills Prevention Program
연구 개요
상세 설명
Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results.
The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments.
The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources.
The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20010
- Children's National Medical Center
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Virginia
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Richmond, Virginia, 미국, 23284
- Virginia Commonwealth University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Seen for Diabetes care at Virginia Commonwealth University or Children's National Medical Center
- Child ages 11-14
- Type 1 Diabetes
- Fluent in English
- Ability to comprehend and complete questionnaires independently
Exclusion Criteria:
- The presence of any other major disease
- The presence of any severe diabetic complications which could impair test performance
- Use of any medication that affects the CNS other than insulin
- Inability to speak/comprehend and read English
- Placement in special classes for the mentally disabled
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 당뇨병 교육
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Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments.
This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
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실험적: TeamWork CS Sessions
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The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care.
Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted.
Families meet with a study interventionist in conjunction with four consecutive medical appointments.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Parental involvement and Disease care behaviors
기간: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
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Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Glycohemoglobin levels, Adverse effects and Blood glucose variability
기간: Baseline, 3, 6, 9, 12, 15, 18, and 24 months
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Baseline, 3, 6, 9, 12, 15, 18, and 24 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Randi Streisand, Ph.D., Children's National Research Institute
- 수석 연구원: Clarissa S Holmes, Ph.D., Virginia Commonwealth University
- 연구 책임자: Rusan Chen, Ph.D., Georgetown University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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