Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical
연구 개요
상세 설명
The proposed project is a randomized control trial to assess the efficacy of an SBIRT model tailored to youth with chronic medical conditions. This trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. The first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. In the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief Intervention OR Treatment as Usual (TAU). In the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries.
At baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. The investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Boston Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 14-17 year-old youth presenting for routine medical care in the Rheumatology clinic or Endocrinology clinic at Boston Children's Hospital (BCH)
- A diagnosis of type 1 diabetes for at least a year or a diagnosis of a Rheumatologic condition for at least a year.
- Able to read and understand English at a middle school level or greater
- Consent to participation in the study and consent to the 6 month and 12 month follow up assessments.
Exclusion Criteria:
- Patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team
- Unable to speak/read English at a middle school reading level
- Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
- Do not consent to 6 month and 12 month re-assessment.
- Patients who are pregnant at baseline
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 |
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실험적: Intervention
Those in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education on substance use.
Content in the intervention will focus on health promotion and will deliver positive messages about health.
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Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
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간섭 없음: Control
Those in the control arm will receive treatment as usual.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.
기간: 12 months post intervention
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We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.
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12 months post intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
기간: 12 months post intervention
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We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.
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12 months post intervention
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Perceived risk of harm of substance use
기간: 12 months post intervention
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We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.
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12 months post intervention
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Medication Adherence measured by self-report
기간: 12 months post intervention
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12 months post intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sharon Levy, MD, MPH, Boston Children's Hospital
- 수석 연구원: Elissa Weitzman, ScD, MSc, Boston Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P00021649
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Brief psycho-educational intervention에 대한 임상 시험
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RANDNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한
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University of MichiganNational Institute on Drug Abuse (NIDA)완전한
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University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한