- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07664644
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
2026년 6월 18일 업데이트: Dana Litt, The University of Texas at Arlington
A Hybrid Type 1 Effectiveness Implementation Trial of a Parent-Based Intervention to Address Social Media Influences on Adolescent Alcohol Outcomes
The central goal of this application is to conduct a Hybrid Type 1 effectiveness-implementation randomized controlled trial to test the comparative effectiveness of an alcohol and social media parent-based intervention (PBI), compared to both a combined approach whereby parents receive the alcohol and social media PBI and adolescents receive an alcohol and social media personalized feedback intervention (PFI) and to an efficacious alcohol PBI handbook.
Additionally, we will determine key implementation determinants that are crucial to optimizing effectiveness when delivered in community settings.
The proposed study will address each of these goals in turn by enrolling parent and adolescent (age 12-17) dyads and collaborating with key community members.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
900
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dana Litt, PhD
- 전화번호: 3032044109
- 이메일: dana.litt@uta.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Parents/legal guardian inclusion criteria:
- Have a child between the ages of 12-17 who lives with them
- Believe that their child is active on at least one social media platform
- Live in Texas
- Provide a valid email and phone number
- Own a cell phone with text messaging capabilities and be okay with receiving messages
- Provide valid contact information for their adolescent
- Willing to participate in respective phase.
Adolescent inclusion criteria:
- Have an eligible parent with whom they live
- Age 12-17
- Live in Texas
- Active at least weekly on at least one social media platform
- Provide a valid phone number and email address
- Own a cell phone with text messaging capabilities and be okay with receiving text messages,
- Willing to participate in respective phase
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work.
The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors.
Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
|
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work (PI: Litt, R21AA024163; Litt et al., 2023; Lewis et al., 2019; Larimer et al., 2021, 2023).
The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors.
Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
|
|
활성 비교기: Alcohol and Social Media PBI
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs.
The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules).
The website will allow parents to navigate through the modules at their own pace/sequence.
Each module will have interactive elements including animations, infographics, and videos to highlight key content.
Parents will be sent one text message per week encouraging them to use the website.
|
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs.
The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules).
The website will allow parents to navigate through the modules at their own pace/sequence.
Each module will have interactive elements including animations, infographics, and videos to highlight key content.
Parents will be sent one text message per week encouraging them to use the website.
|
|
활성 비교기: Alcohol PBI
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish.
The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.
|
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish.
The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Drinking Refusal Self-Efficacy
기간: Baseline, 1, 6, 12 month assessments
|
The Drinking Refusal Self-Efficacy Questionnaire will assess beliefs in one's ability to resist alcohol (Young et al., 2007; α = .96).
Responses range from 1 (I am very sure I would drink) to 6 (I am sure I would not drink) with higher scores indicating greater drinking refusal self-efficacy.
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Baseline, 1, 6, 12 month assessments
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Alcohol-related social media communication
기간: Baseline, 1, 6, 12 month assessments
|
Alcohol-related social media communication between parents and adolescents will be assessed using the "Alcohol-related Social Media Communication Scale, which is adapted from Turrisi et al., 2000; α = .96).
Participants will indicate whether they spoke about a range of topics (yes/no) in the past month with higher scores indicating greater alcohol-related social media communication.
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Baseline, 1, 6, 12 month assessments
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Alcohol Willingness
기간: Baseline, 1, 6, 12 month assessments
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The willingness measure will assess adolescent willingness to drink in certain scenarios (α = .85;
Gerrard et al., 2008) using a response rage of 0 (not at all willing) to 4 (extremely willing).
Higher scores indicate greater willingness to use alcohol.
|
Baseline, 1, 6, 12 month assessments
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Alcohol Initiation
기간: Baseline, 1, 6, 12 month assessments
|
Alcohol initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to participants' reported date of first use using timeline follow-back methods (Sobell & Sobell, 1992) and reporting the approximate date they first used alcohol, an approach used in our current work (R01AA025611).
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Baseline, 1, 6, 12 month assessments
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 7월 1일
기본 완료 (추정된)
2030년 8월 1일
연구 완료 (추정된)
2030년 8월 1일
연구 등록 날짜
최초 제출
2026년 6월 15일
QC 기준을 충족하는 최초 제출
2026년 6월 18일
처음 게시됨 (실제)
2026년 6월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 18일
마지막으로 확인됨
2026년 6월 1일
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. .