Eating Disorder Clinical Trial
Official title:
Implementation Support for Prevention Program Delivery by College Peer Educators
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03317587 -
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
|
N/A | |
Completed |
NCT03197519 -
Evaluation of a Program for Eating Disorders That Combines Cognitive-behavioral Therapy With Online Psychological Treatment
|
N/A | |
Withdrawn |
NCT02978742 -
Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder
|
N/A | |
Completed |
NCT02419326 -
Uniting Couples In the Treatment of Eating Disorders (UNITE)
|
N/A | |
Completed |
NCT03013244 -
Reducing Eating Disorder Risk Factors Among College-Aged Males
|
N/A | |
Completed |
NCT00184301 -
A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder.
|
N/A | |
Recruiting |
NCT03503981 -
Examining Change Mechanisms in Psychotherapy
|
||
Completed |
NCT03097874 -
Adaptive Treatment for Adolescent Anorexia Nervosa
|
N/A | |
Completed |
NCT03911674 -
Effects of Oral Stimulation in Preterm Infants
|
Phase 3 | |
Recruiting |
NCT03218670 -
Your Health in On Click
|
N/A | |
Completed |
NCT03292146 -
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
|
Phase 3 | |
Completed |
NCT03502564 -
Integrated Treatment for Co-occurring Eating Disorders and Posttraumatic Stress Disorder
|
N/A | |
Recruiting |
NCT02960152 -
Periodontal Impact of Eating Disorders (the PERIOED Study)
|
N/A | |
Completed |
NCT01985178 -
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
|
N/A | |
Terminated |
NCT01183377 -
Frequency of Female Athlete Triad Among Elite Female Athlete of Iran in Different Sport in 2007
|
N/A | |
Completed |
NCT00000448 -
Naltrexone Treatment for Alcoholic Women
|
Phase 4 | |
Completed |
NCT06230107 -
The Effects of Nutritional Intervention in Participants With Eating Disorders.
|
N/A | |
Completed |
NCT03712748 -
Online Imaginal Exposure
|
N/A | |
Completed |
NCT04091477 -
Impact of Neuropsychological Alteration of Patients With Eating Disorders
|
||
Completed |
NCT03317379 -
Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy
|
N/A |