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临床试验/NCT03409809
NCT03409809已完成不适用

Implementation Support for Prevention Program Delivery by College Peer Educators

Oregon Research Institute8 个研究点 分布在 1 个国家目标入组 2,261 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,261
试验地点
8
主要终点
Fidelity of Program Implementation as assessed by 25-item Session Adherence Scale (Stice et al., 2013a)

研究概览

简要总结

This project will evaluate 3 approaches of implementation support for university peer leaders who will deliver a prevention program with a particularly strong evidence-base compared to changes observed in outcomes in response to usual care at the universities before implementation. This study aims to advance knowledge of this innovative and economical way to provide college prevention programs to reduce the burden of mental illness in the college student population.

详细描述

Several interventions for mental health problems are efficacious and effective, but few are routinely offered to college students, who represent 59% of young adults. This is regrettable because college students are at high risk for mental health problems (e.g., depression, substance abuse, eating disorders), and college counseling centers lack sufficient clinicians to offer individual therapy to all afflicted students and are not well positioned to deliver prevention programs. One solution for this service shortfall is to have peer educators deliver scripted group-based prevention programs, which can more efficiently reduce the burden of mental illness than individual therapy. Targeting college students is a cost-effective tactic for delivering prevention programs and has vast potential reach because 85% of colleges have peer educator programs. Peer educators have effectively delivered several prevention programs, sometimes producing larger effects than clinicians. This study will investigate 3 levels of implementation support (training, training with technical assistance, and training with technical assistance and quality assurance) and the impacts of differing levels of implementation support on program outcomes across 57 college campuses nationwide. Specifically we have five aims for this study:

Aim 1: Test whether greater implementation support is associated with graded increases in fidelity and competence in delivering the scripted prevention program. This will be assessed by an established procedure for reliably rating fidelity and competence of audio-recorded intervention sessions.

Aim 2: Test whether greater implementation support, which should increase fidelity and competence of intervention delivery, is associated with graded increases in student attendance of intervention sessions (recorded by the peer educators) and effectiveness of the prevention program (measured by pre-to-post changes in core outcomes assessed with anonymous surveys completed by group participants) and compared to parallel pre-to-post change data collected from students at the colleges before implementation is initiated.

Aim 3: Test whether greater implementation support is associated with graded increases in program reach (% of female students at each college who complete the prevention program during the 1-year implementation period) and sustainability (% of female students at each college who complete the prevention program during the subsequent 2-year sustainability monitoring period).

Aim 4: Test whether Consolidated Framework for Implementation of Research (CFIR) indices of perceived intervention factors, outer and inner setting factors, peer educator attributes, and process factors after the initial training correlate with fidelity, competence, attendance, effectiveness, and reach over the 1-year implementation period and with sustainability. We will test whether at the end of the initial implementation period the 3 conditions differ on relevant CFIR indices and on the progress and speed of implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • College undergraduate student Peer Educators with an interest in promoting body satisfaction
  • Willing to attend a 2-day Body Project train-the-trainer (TTT) training

排除标准

  • Undergraduate college students from a college or university* that does not have a formal Peer Education Program
  • Peer Educator Supervisor
  • Inclusion Criteria:
  • College or University* staff members with an interest in promoting body satisfaction
  • Willing to attend a 2-day Body Project train-the-trainer (TTT) training
  • Exclusion Criteria:
  • Not a staff member
  • Inclusion Criteria:
  • Clinician working at a US College or University*
  • Exclusion Criteria:
  • Not a clinician
  • Body Project Group Participant
  • Inclusion Criteria:
  • College* students with an interest in promoting body satisfaction
  • Exclusion Criteria:
  • Not a college student
  • Usual Care Participant
  • Inclusion Criteria:
  • College* students with an interest in promoting body satisfaction
  • Exclusion Criteria:
  • Not a College* student
  • Current or past participant in a Body Project group
  • Participating students and staff are randomized at the school level.

结局指标

主要结局

Fidelity of Program Implementation as assessed by 25-item Session Adherence Scale (Stice et al., 2013a)

时间窗: 12 months

Peer educators' adherence to scripted intervention manual and accuracy of script delivery as coded through evaluation of audio-recorded sessions by two clinicians independently coding a random selection of sessions using the Session Adherence Scale. Coders will indicate the extent to which peer leaders adhere to the 25 total total necessary components of the 4-session intervention script using a scoring guide ranging from 10 (indicating no adherence) to 100 (indicating perfect adherence) with a possible total score range of 250 to 2500. Inter-rater agreement for Session Adherence Scale has been found to be .92 (Stice et al., 2013a).

Competence of Program Implementation as assessed by 12-item Group Leader Competence Scale (Stice et al., 2013a)

时间窗: 12 months

Peer educators' competence with intervention delivery as assessed by 12-item Group Leader Competence Scale measuring various indicators of a competent group facilitator (e.g. leaders allot equal speaking time for all members.) Coders will indicate the extent to which peer leaders show competence in their delivery of the scripted intervention across 12 items using a scoring guide ranging from 10 (indicating poor competence) to 100 (indicating superior competence) with a possible total score range of 120 to 1200. Inter-rater agreement for Group Leader Competence Scale has been found to be .96 (Stice et al., 2013a).

次要结局

  • Sustainability(24 months)
  • Implementation Progress(Baseline, 12 months)
  • Reach(12 months)
  • Relative Cost-Effectiveness(12 months, 24 months)
  • Peer Educator Self-Efficacy(Baseline, 1 week or less post-training, 12 months)
  • Outer Setting(Baseline)
  • Attendance(12 months)
  • Delivery Cost(12 months)
  • Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale(1 Week or less post training)
  • Provider Attitudes Towards Evidence-Based Interventions(Baseline, 1 week or less post-training, 12 months)
  • Project Knowledge(Baseline, 1 week or less post-training, 12 months)
  • Inner Setting(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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