NCT06686784

Brief Summary

Coming out of the COVID-19 pandemic many youth are experiencing declines in physical activity and worsening mental health (e.g., depression symptoms). These declines are exacerbated among underserved youth who experience greater barriers to health services and exposure to life stressors that put them at increased risk for impaired mental, emotional, and behavioral health. School-based afterschool programming is an important strategy to reach this population of youth and provides intervention at a time when youth are likely to otherwise be in environments not supportive of health. Further participation in extracurricular activities has been shown to be a protective factor for youth mental health. However, consistent with the Behavioral Theory of Depression, youth who are currently inactive and who have depression symptoms are unlikely to participate in afterschool programming on their own and likely require heightened positive reinforcement when they do attend to encourage retention. Given the high prevalence of youth who experience symptoms of depression and resource and staffing challenges faced by many schools, the level of support needed to engage students to consistently participate and benefit from afterschool programming is often beyond the capacity of school-based afterschool programs. In partnership with a local afterschool program for middle school students in a low resource community, the investigators developed an augmented version of the current afterschool program in which college students are trained to mentor and assist in the afterschool program, expanding the capacity of the afterschool program to engage students. The mentoring intervention uses behavioral activation principles to help youth connect their behaviors with their mood and support youth to engage in behaviors that improve their mood, including physical activity. The main purpose of this study is to pilot the feasibility of the newly developed intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 24, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

November 11, 2024

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • intervention feasibility

    This will be measured by participant semester 1 rate of attendance at the after school program (i.e., the number of days attended divided by the number of days the class(es) the student was signed up for were offered in semester 1)

    4 months

  • intervention feasibility

    This will be measured by participant semester 2 rate of attendance at the after school program (i.e., the number of days attended divided by the number of days the class(es) the student was signed up for were offered in semester 2)

    8 months

Secondary Outcomes (5)

  • Depression symptoms

    Baseline

  • Depression symptoms

    4 months

  • Depression symptoms

    8 months

  • Activity level in after school program

    4 months

  • Activity level in after school program

    8 months

Study Arms (2)

School A

EXPERIMENTAL

Middle school students at School A who participate in the after school program. They will receive after school as usual in months 1-4, followed by after school plus in months 5-8.

Behavioral: After School Plus

School B

EXPERIMENTAL

Middle school students at School B who participate in the after school program. They will receive after school plus in months 1-4, followed by after school as usual in months 5-8.

Behavioral: After School Plus

Interventions

The afterschool program as usual runs M-H and consists of a variety of clubs from which middle school students chose to enroll for a semester (\~4 months). Clubs are offered on either a M/W or T/H schedule. Students receive a snack in the cafeteria each day before attending their class. Afterschool plus is the same as "Afterschool as Usual" with the addition of young adult mentors. Following snack, mentors will lead students in a short emotion regulation exercise including physical activity and breathing exercises. Mentors will prompt students to identify how they are feeling and make connections between the activities they are doing and their mood and then do activities with students in each class. On T/H, \~4 mentors will lead a new "DiscoverU " club which is based on behavioral activation principles and spends more time helping students identify and do more activities that improve their mood. The class promotes physical activity as an important strategy for mental health.

School ASchool B

Eligibility Criteria

Age9 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any 6th , 7th , or 8th grade student who is enrolled in their after school plus program at a participating middle school
  • Any parent of a student who is enrolled in the study is eligible to participate.
  • Any mentor in the after school plus program is eligible to participate.
  • Any staff member affiliated with the after school program at a participating middle school

You may not qualify if:

  • Have a substantial cognitive impairment that would prevent the completion of data collection activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Katherine Hendel

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The crossover occurs after the first semester (end of Month 4). The study will occur with two middle schools. Months 1-4 Participants at "School A" (Arm 1) receive the Afterschool as Usual condition in the first semester. Participants at "School B" (Arm 2) receive the Afterschool Plus condition in the first semester. Months 5-8 Participants at "School A" (Arm 1) receive the Afterschool Plus condition in the second semester. and the participants at "School B" (Arm 2) receive afterschool as Usual condition in the second semester.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 13, 2024

Study Start

September 24, 2024

Primary Completion

June 17, 2025

Study Completion

March 9, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations