NCT03409809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

5.8 years

First QC Date

December 7, 2017

Last Update Submit

January 12, 2024

Conditions

Eating Disorder

Keywords

Implementation SupportEating DisorderDisseminationPreventionPeer Leader

Outcome Measures

Primary Outcomes (2)

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

    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).

    12 months

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

    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).

    12 months

Secondary Outcomes (12)

  • Attendance

    12 months

  • Reach

    12 months

  • Sustainability

    24 months

  • Delivery Cost

    12 months

  • Relative Cost-Effectiveness

    12 months, 24 months

  • +7 more secondary outcomes

Study Arms (3)

Training Alone

EXPERIMENTAL

This condition involves an intensive 2-day initial train-the-trainer workshop that simultaneously trains peer educators to deliver the intervention and campus supervisors to train and support future peer educators, plus the facilitator guide and facilitator support website.

Behavioral: Training

Training and Technical Assistance

EXPERIMENTAL

This condition involves an intensive 2-day initial train-the-trainer workshop that simultaneously trains peer educators to deliver the intervention and campus supervisors to train and support future peer educators, plus the facilitator guide and facilitator support website. This condition additionally contains a 1/2 day implementation training to articulate goals, needs, leadership structure, adoption options, recruitment strategies, and communication.

Behavioral: Training and Technical Assistance

Training, Tech. Assist., Qual. Assurance

EXPERIMENTAL

This condition involves an intensive 2-day initial train-the-trainer workshop that simultaneously trains peer educators to deliver the intervention and campus supervisors to train and support future peer educators, plus the facilitator guide and facilitator support website. This condition additionally contains a 1/2 day implementation training to articulate goals, needs, leadership structure, adoption options, recruitment strategies and communication. Furthermore, this condition will have 1 year of technical assistance, coaching, and quality assurance to enhance implementation skills and sustainability.

Behavioral: Training, Tech. Assistance, Quality Assurance/Improvement

Interventions

TrainingBEHAVIORAL

Level of Support: Intensive 2-day train-the-trainer workshop, facilitator guide and facilitator support website.

Training Alone
Training and Technical AssistanceBEHAVIORAL

Level of Support: Intensive 2-day train-the-trainer workshop, facilitator guide, and facilitator support website, plus half-day implementation training to further define goals, needs, leadership structure and strategy for adoption and recruitment.

Training and Technical Assistance
Training, Tech. Assistance, Quality Assurance/ImprovementBEHAVIORAL

Level of Support: As for "Training and Technical Assistance" arm, plus 1-year of technical assistance, coaching, and quality assurance to enhance skills for implementation and sustainability.

Training, Tech. Assist., Qual. Assurance

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Undergraduate college students from a college or university\* that does not have a formal Peer Education Program
  • Peer Educator Supervisor
  • 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
  • Not a staff member
  • Clinician
  • Clinician working at a US College or University\*
  • Not a clinician
  • Body Project Group Participant
  • College\* students with an interest in promoting body satisfaction
  • Not a college student
  • Usual Care Participant
  • College\* students with an interest in promoting body satisfaction
  • Not a College\* student
  • Current or past participant in a Body Project group
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Trinity University

San Antonio, Texas, 78212, United States

Location

Related Publications (3)

  • Duru C, Bearman SK, Rohde P, Shaw H, Stice E. A qualitative study of modifications and adaptations to an evidence-based prevention intervention during implementation on college campuses. Eat Disord. 2025 Apr 30:1-17. doi: 10.1080/10640266.2025.2497638. Online ahead of print.

    PMID: 40305559DERIVED

  • Bearman SK, Rohde P, Pauling S, Gau JM, Shaw H, Stice E. Predictors of the sustainability for an evidence-based eating disorder prevention program delivered by college peer educators. Implement Sci. 2024 Jul 4;19(1):47. doi: 10.1186/s13012-024-01373-9.

    PMID: 38965587DERIVED

  • Stice E, Rohde P, Gau JM, Shaw H. Implementation factors that predict larger effects from a peer educator delivered eating disorder prevention program at universities. J Consult Clin Psychol. 2023 Feb;91(2):60-70. doi: 10.1037/ccp0000783. Epub 2023 Feb 23.

    PMID: 36821334DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Eric Stice, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

January 24, 2018

Study Start

January 15, 2018

Primary Completion

November 15, 2023

Study Completion

November 30, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)