NCT07129070

Brief Summary

This study will evaluate the usability, feasibility, and acceptability of a novel multi-level Just-In-Time Training (JITT) implementation strategy (JITT-EBP) that aims to equip mentors and mentor supervisors to implement evidence-based practices (EBPs) with fidelity using methods that are sustainable in rural communities. JITT-EBP integrates (a) self-directed, on-demand, online training modules for mentors and mentor supervisors, (b) synchronous evidence-based supervision strategies, and (c) an apprenticeship delivery model in which EBPs are co-led by an experienced mentor and a novice mentor, providing opportunity for in-the-moment training and support. The study will conduct a pilot hybrid type 2 effectiveness-implementation trial to evaluate the use of JITT-EBP compared to usual training for implementing mentor-delivered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program. 96 adolescents (age 12-17) and their parents, 8-18 mentors (depending on amount of turnover), and 4 mentor supervisors will be enrolled in the trial.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025May 2028

First Submitted

Initial submission to the registry

July 22, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 18, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

July 22, 2025

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Feasibility of Intervention Measure (FIM) - Week 12

    Mentor and mentor supervisor report of JITT-EBP feasibility, with higher value indicating higher feasibility

    Week 12

  • Acceptability of Intervention Measure (AIM) - Week 12

    youth, parent, mentor, and mentor supervisor report of IPT-AST acceptability, with higher value indicating higher acceptability.

    Week 12

  • Intervention Appropriateness Measure (IAM) - Week 12

    Mentor and mentor supervisor report of JITT-EBP appropriateness, with higher value indicating higher appropriateness.

    Week 12

  • Client Satisfaction Questionnaire (CSQ-8) - Week 12

    Youth and parent report of satisfaction with IPT-AST program, with , with higher value indicating more satisfaction.

    Week 12

Secondary Outcomes (26)

  • Fidelity

    Week 12

  • Cost of implementation

    Year 2

  • Revised Child Anxiety and Depression Scale-25 (RCADS-25) - Week 6

    Week 6

  • Revised Child Anxiety and Depression Scale-25 (RCADS-25) - Week 12

    Week 12

  • Revised Child Anxiety and Depression Scale-25 (RCADS-25) - Week 24

    Week 24

  • +21 more secondary outcomes

Study Arms (2)

IPT-AST implemented via Just-In-Time Training (JITT-EBP)

ACTIVE COMPARATOR

IPT-AST = Interpersonal Psychotherapy-Adolescent Skills Training

Behavioral: Interpersonal Psychotherapy-Adolescent Skills Training via Just-In-Time Training (JITT) implementation strategy

IPT-AST implemented via usual training

ACTIVE COMPARATOR

IPT-AST = Interpersonal Psychotherapy-Adolescent Skills Training

Behavioral: Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) implemented via usual training

Interventions

IPT-AST is a group-based EBP that aims to prevent depression and support emotional well-being by helping youth develop skills to foster healthy relationships. Youth learn about the links between feelings and interpersonal interactions, and they learn communication strategies and interpersonal problem-solving skills that they can apply to their relationships. JITT-EBP integrates (a) self-directed, on-demand, online training modules for mentors and mentor supervisors, (b) synchronous evidence-based supervision strategies, and (c) an apprenticeship delivery model in which EBPs are co-led by an experienced mentor and a novice mentor, providing opportunity for in-the-moment training and support.

IPT-AST implemented via Just-In-Time Training (JITT-EBP)

IPT-AST is a group-based EBP that aims to prevent depression and support emotional well-being by helping youth develop skills to foster healthy relationships. Youth learn about the links between feelings and interpersonal interactions, and they learn communication strategies and interpersonal problem-solving skills that they can apply to their relationships. Usual training involves (a) a one-day virtual training conducted by an IPT-AST expert prior to the beginning of the intervention, and (b) synchronous evidence-based supervision strategies.

IPT-AST implemented via usual training

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • student at a partnering rural middle school or high school
  • age 12-17
  • have English speaking/reading/writing ability at a level to participate in IPT-AST
  • youth's parent has English or Spanish-speaking/reading/writing ability at a level to participate in research activities.

You may not qualify if:

  • moderate or severe depression (PHQ-9 \> 10)
  • active suicidal ideation with a plan and/or intent, requiring higher level of care
  • Youth does not have English-speaking ability at a level to participate in IPT-AST
  • youth's parent does not have English or Spanish-speaking/reading/writing ability at a level to participate in research activities.
  • age 18 or older
  • have completed the typical mentor or mentor supervisor screening and selection process at partnering mentoring organization (including a background check)
  • are available to facilitate the program during after-school hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Meredith Gunlicks-Stoessel, PhD, LP

    University of Minnesota

    PRINCIPAL INVESTIGATOR
  • Lindsey Weiler, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gracie Meyer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Youth, mentor supervisors, and mentors will be randomized to IPT-AST delivered via JITT-EBP or usual training. Youth will be block randomized using randomly permuted blocks of 2 and 4. Randomization for youth will be stratified by sex and level of depression symptoms (PHQ-9 \< 5 and \> 5).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 19, 2025

Study Start

December 18, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations