Pilot of a Drug Education Curriculum for Middle and High School Students (iDECIDE)
Development of a Drug Education Curriculum for Middle and High School Students
The goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it aims to answer is:
1) What is the impact of iDECIDE on the the knowledge of drug effects and teen brain development, attitudes and perceptions of drug-related harms, and willingness to quit or reduce substance use?
Participants will be asked to participate in 4 sessions of the iDECIDE curriculum and complete surveys and interview questionnaires over the course of approximately 3 months.
연구 개요
상세 설명
This study will be a one-arm pilot study enrolling approximately 100 middle and high school students who have endorsed substance use in the past month. Participants will be followed over 3 months. All participants will receive iDECIDE developed to provide behavioral support and psychoeducation via videoconference or in-person visits. The purpose of iDECIDE is to provide students with the knowledge and skills they need to make healthy decisions regarding substance use. Data collection will occur during seven visits over the span of approximately three months, including one baseline visit, four weekly visits during the intervention phase of the study, and then two follow-up visits. The follow-up visits will occur at approximately one week and one month following the end-of-intervention. Participants will complete questionnaires and assessments throughout the study. Primary outcomes (Knowledge of Drug Effects and Brain Development readiness to quit, readiness to reduce, perceptions of harm) will be assessed at visit 1 (baseline), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children and adolescents who are currently enrolled in middle or high school;
- Have currently used (i.e., at least once in the past 30 days) any substance without a prescription;
- Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
- Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
- Competent and able to provide written informed consent (if age 18 or older);
- Able to communicate in English language;
- Able to commit to 7 study visits in approximately 2 months;
- Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
- Has access to a reliable internet connection and a device that can run Zoom.
Exclusion Criteria:
- Ever been in substance use treatment;
- Ever engaged in IV drug use;
- Current daily alcohol, or daily non-medical benzodiazepine and/or opioid use.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: iDECIDE
Participants will…
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iDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knowledge of Drug Effects & Brain Development
기간: Baseline, one-week follow-up, one-month follow-up
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Knowledge of Drug Effects and Brain Development will be measured by number of items correct on a 25-item multiple-choice questionnaire that assesses knowledge taught in the iDECIDE curriculum, including neurobiology of addiction, side effects of substance, and industry tactics to market substances to young audiences. |
Baseline, one-week follow-up, one-month follow-up
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Readiness to Quit or Reduce Substance Use
기간: Baseline, one-week follow-up, one-month follow-up
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Participants will complete a Readiness Ruler to determine how ready they are to quit and reduce their primary substance on a scale from 1 (not at all ready) to 10 (very ready). |
Baseline, one-week follow-up, one-month follow-up
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Perceived Harm of Substance Use
기간: Baseline, one-week follow-up, one-month follow-up
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The Perceived Harm of Substance Use measure was modified from the 2010 National Survey on Drug Use and Health. Participants will assess their perceived harm of various forms of substance use using four response categories that range from no risk to great risk. |
Baseline, one-week follow-up, one-month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of Substance Use
기간: Baseline, one-week follow-up, one-month follow-up
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The Timeline Follow-Back (TLFB) will be used to measure number of days the participant used a substance, which substances were used, and the frequency of which substances were used. The initial TLFB at the baseline visit will measure substances used in the past 90 days. Participants will be prompted to share their substance use since their baseline and follow-up visits during the one-week and one-month follow-up visits, respectively. |
Baseline, one-week follow-up, one-month follow-up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anxiety symptoms
기간: Baseline, one-week follow-up, one-month follow-up
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The Screen for Child Anxiety Related Emotional Disorders Revised (SCARED-R) questionnaire is a 66-item self-report questionnaire to measure DSM child anxiety symptoms. Participants are asked to endorse how frequently they have experienced each symptom on a 3-point scale: 0 ("almost never"), 1 ("sometimes"), and 2 ("often"). A total score (0-132) and anxiety sub-scores are calculated by adding item scores. |
Baseline, one-week follow-up, one-month follow-up
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Depressive symptoms
기간: Baseline, one-week follow-up, one-month follow-up
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The Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a 20-item questionnaire for assessing past-week depressive symptoms in children and adolescents. Responses range from 0 ("not at all") to 3 ("a lot"). Total scores can range from 0-60. |
Baseline, one-week follow-up, one-month follow-up
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
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 (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
- 2020P000727
- INTF2300H78500224179 (기타 보조금/기금 번호: Massachusetts Department of Public Health)
- INTF2400H78500224455 (기타 보조금/기금 번호: Massachusetts Department of Public Health)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data that underlie reported results (after de-identification [text, tables, figures, and appendices]), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@harvard.mgh.edu. To gain access, data requestors will need to sign a data access agreement.
IPD 공유 기간
Beginning 3 months and ending 5 years following article publication
IPD 공유 액세스 기준
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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