Eating DisorderPINCT03409809
Implementation Support for Prevention Program Delivery by College Peer Educators
A study testing Training, Training and Technical Assistance and Training, Tech. Assistance, Quality Assurance/Improvement in people with Eating Disorder, run by Oregon Research Institute at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Training, Training and Technical Assistance and Training, Tech. Assistance, Quality Assurance/Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,261 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jan 2018to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
- Clinician working at a US College or University*
- College* students with an interest in promoting body satisfaction
- College* students with an interest in promoting body satisfaction
Who cannot join
- Undergraduate college students from a college or university* that does not have a formal Peer Education Program
- Peer Educator Supervisor
- Not a staff member
- Clinician
- Not a clinician
- Body Project Group Participant
Show all 11Show fewer
- Not a college student
- Usual Care Participant
- Not a College* student
- Current or past participant in a Body Project group
- Participating students and staff are randomized at the school level.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas at Austin
Austin, Texas, 78712
Oregon Research Institute
Eugene, Oregon, 97403
Trinity University
San Antonio, Texas, 78212
Stanford University
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Eating Disorder
- Being tested
- Training, Training and Technical Assistance, Training, Tech. Assistance, Quality Assurance/Improvement
- Keywords
- Implementation Support, Eating Disorder, Dissemination, Prevention, Peer Leader
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Level of Support: Intensive 2-day train-the-trainer workshop, facilitator guide and facilitator support website.
Training and Technical AssistanceBehavioural
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, Tech. Assistance, Quality Assurance/ImprovementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Training, Tech. Assistance, Quality Assurance/Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months
Secondary outcomes (12)
Attendance
Attendance levels of participants as recorded by peer educators
Measured: 12 months
Reach
Percentage of students who complete the prevention program at 1 year post-educator training
Measured: 12 months
Sustainability
Percentage of students who complete the prevention program during the subsequent 2-year sustainability monitoring period
Measured: 24 months
Delivery Cost
Dollar amount delivery cost for each arm of the implementation support model
Measured: 12 months
Relative Cost-Effectiveness
Relative cost-effectiveness of each arm of the implementation support model
Measured: 12 months, 24 months
Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale
Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale. Respondents will indicate their level of agreements with the 27 items using a 5-point Likert-type scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree) with a possible score ranging from 27 to 135.
Measured: 1 Week or less post training
Project Knowledge
Peer educators' declarative project knowledge as measured by the 20-item Body Project Knowledge Scale. Peer educators will indicate whether the statements in this scale are "true" or "false," with a possible score ranging from 0 for no correct replies to 20 for every answer correct.
Measured: Baseline, 1 week or less post-training, 12 months
Provider Attitudes Towards Evidence-Based Interventions
Provider Attitudes Towards Evidence-Based Interventions as measured by the 50-item Evidence-Based Practice Attitude Scale (EBPAS-50), which will assess provider attitudes toward adopting evidence-based intervention (Aarons, 2004); it has four subscales: Appeal (intuitive appeal of evidence-based interventions), Requirements (likelihood of adopting evidence-based interventions given supervisor, organizational, or system requirements), Openness (general openness to new practices), and Divergence (perceived divergence between research developed interventions and current practice), which sum up to a total score representing respondents' global attitude toward adopting and using evidence-based practice. Respondents will indicate the extent to which they agree with each item on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very great extent). A higher total score indicates a more positive attitude toward adopting and using evidence-based practice. 23 items are reverse-scored.
Measured: Baseline, 1 week or less post-training, 12 months
Implementation Progress
Implementation Progress as measured by the Prevention Implementation Progress Scale
Measured: Baseline, 12 months
Peer Educator Self-Efficacy
Peer Educator Self-Efficacy as measured by the 14-item Peer Educator Self-Efficacy Questionnaire. Respondents will degree of confidence on a 6-point scale ranging from 1 (No Confidence) to 6 (Complete Confidence). Scores will range from 14 (no demonstrated peer educator self-efficacy) to 84 (high peer educator self-efficacy.)
Measured: Baseline, 1 week or less post-training, 12 months
Inner Setting
Inner Setting sub domains assessed using the Team Climate Inventory
Measured: Baseline, 12 months
Outer Setting
Evaluate presence or absence of formal policies related to evidence-based programs, fiscal and other organizational resources for peer educators based on two coded interviews
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start15 Jan 2018
- Primary completion15 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of Texas at Austin, Trinity University, Texas
- Responsible party
- Sponsor
- Investigators
- Eric Stice, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409809
- Sponsor's protocol ID
- MH112743
- Acronym
- PI
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2017
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jul-Aug;34(4):397-413. doi: 10.1080/10640266.2025.2497638. Epub 2025 Apr 30.
PubMed 40305559Bearman 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.
PubMed 38965587Stice 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.
PubMed 36821334
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Support for Prevention Program Delivery by College Peer Educators
- ClinicalTrials.gov ID
- NCT03409809
- Acronym / sponsor ID
- PI / MH112743
- Conditions
- Eating Disorder
- Keywords
- Implementation Support, Eating Disorder, Dissemination, Prevention, Peer Leader
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,261 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- Stanford University, University of Texas at Austin, Trinity University, Texas
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training Alone | Experimental | Behavioral: TrainingThis 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. |
| Training and Technical Assistance | Experimental | Behavioral: Training and Technical AssistanceThis 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. |
| Training, Tech. Assist., Qual. Assurance | Experimental | Behavioral: Training, Tech. Assistance, Quality Assurance/ImprovementThis 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- College* students with an interest in promoting body satisfaction
Key exclusion criteria (11 listed)
- Peer Educator Supervisor
- Clinician
- Body Project Group Participant
- Usual Care Participant
- Not a College* student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingLevel of Support: Intensive 2-day train-the-trainer workshop, facilitator guide and facilitator support website. | Behavioural | Training Alone |
| Training and Technical AssistanceLevel 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. | Behavioural | Training and Technical Assistance |
| Training, Tech. Assistance, Quality Assurance/ImprovementLevel 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. | Behavioural | Training, Tech. Assist., Qual. Assurance |
Primary outcome
Fidelity of Program Implementation as assessed by 25-item Session Adherence Scale (Stice et al., 2013a)
Time frame: 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)
Time frame: 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).
12 secondary outcomes
Attendance
Time frame: 12 months
Reach
Time frame: 12 months
Sustainability
Time frame: 24 months
Delivery Cost
Time frame: 12 months
Relative Cost-Effectiveness
Time frame: 12 months, 24 months
Perceived Characteristics of the Intervention as measured by the 28-item Provider Intervention Adoption Scale
Time frame: 1 Week or less post training
Project Knowledge
Time frame: Baseline, 1 week or less post-training, 12 months
Provider Attitudes Towards Evidence-Based Interventions
Time frame: Baseline, 1 week or less post-training, 12 months
Implementation Progress
Time frame: Baseline, 12 months
Peer Educator Self-Efficacy
Time frame: Baseline, 1 week or less post-training, 12 months
Inner Setting
Time frame: Baseline, 12 months
Outer Setting
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 40305559Duru 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. 2026 Jul-Aug;34(4):397-413. doi: 10.1080/10640266.2025.2497638. Epub 2025 Apr 30.
- Derived from this study: PubMed 38965587Bearman 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.
- Derived from this study: PubMed 36821334Stice 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Stice, PhD principal investigator
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training, Training and Technical Assistance and Training, Tech. Assistance, Quality Assurance/Improvement in people with Eating Disorder, run by Oregon Research Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity of Program Implementation as assessed by 25-item Session Adherence Scale (Stice et al., 2013a) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409809, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.