Clinical trial NCT03409809: Implementation Support for Prevention Program Delivery by College Peer Educators
Official title: Implementation Support for Prevention Program Delivery by College Peer Educators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Keywords: Implementation Support
Eating Disorder
Dissemination
Prevention
Peer Leader
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of Texas at Austin
name: Trinity University, Texas
First posted: 2018-01-24
Enrollment: 2261
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Aim 5: Compare the prevention program delivery cost in the 3 implementation conditions, and the relative cost-effectiveness of each condition in terms of attaining fidelity, competence, attendance, and effectiveness, reach, and sustainability, plus cost-savings from and reductions in waitlists and eating disorder prevalence at clinics.

Starting in March of 2020, virtually-hosted Body Project groups are being recommended to participating Peer Education teams in contexts where in-person groups can not be offered due to COVID-19 social distancing guidelines. Existing research indicates that virtual Body Project groups are a viable and effective alternative in-person groups.

Eligibility criteria: Five Categories of Study Participant: (1) Peer Educator, (2) Peer Educator Supervisor, (3) Clinician, (4) Body Project Group Participant, (5) Usual Care Participant

1. Peer Educator

   Inclusion Criteria:
   * 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

   Exclusion Criteria:
   * Undergraduate college students from a college or university\* that does not have a formal Peer Education Program
2. 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
3. Clinician

   Inclusion Criteria:
   * Clinician working at a US College or University\*

   Exclusion Criteria:
   * Not a clinician
4. Body Project Group Participant

   Inclusion Criteria:
   * College\* students with an interest in promoting body satisfaction

   Exclusion Criteria:
   * Not a college student
5. 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.

Primary outcomes:
measure: Fidelity of Program Implementation as assessed by 25-item Session Adherence Scale (Stice et al., 2013a)
timeFrame: 12 months
measure: Competence of Program Implementation as assessed by 12-item Group Leader Competence Scale (Stice et al., 2013a)
timeFrame: 12 months
Secondary outcomes:
measure: Attendance
timeFrame: 12 months
measure: Reach
timeFrame: 12 months
measure: Sustainability
timeFrame: 24 months
measure: Delivery Cost
timeFrame: 12 months
measure: Relative Cost-Effectiveness
timeFrame: 12 months, 24 months
measure: Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale
timeFrame: 1 Week or less post training
measure: Project Knowledge
timeFrame: Baseline, 1 week or less post-training, 12 months
measure: Provider Attitudes Towards Evidence-Based Interventions
timeFrame: Baseline, 1 week or less post-training, 12 months
measure: Implementation Progress
timeFrame: Baseline, 12 months
measure: Peer Educator Self-Efficacy
timeFrame: Baseline, 1 week or less post-training, 12 months
measure: Inner Setting
timeFrame: Baseline, 12 months
measure: Outer Setting
timeFrame: Baseline
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
city: San Antonio
country: United States
facility: Trinity University
state: Texas
Study officials:
affiliation: Stanford University
name: Eric Stice, PhD
role: PRINCIPAL_INVESTIGATOR
References: