DepressionNCT06686784
Using a Mentoring Afterschool Program to Improve Adolescent Mental Health and Physical Activity: A Pilot Study
A study testing After School Plus in people with Depression, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- After School Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 9 Mar 2026
- 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 9 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Have a substantial cognitive impairment that would prevent the completion of data collection activities.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the detailed description
The proposed study builds from formative work in which the investigators developed an augmented version of an existing afterschool program in which college students are trained to mentor and assist in the afterschool program. Specifically, 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. The study will use a modified, quasi-experimental crossover pilot trial design (n= 1 schools; 1 Afterschool program as usual and 1 After School Plus) conducted in partnership with St. Paul Public School District's school-based afterschool programming, "Flipside". School A will receive After School Plus in semester 1 and After School as Usual in semester 2. School B will receive After School as Usual in semester 1 and After School Plus in Semester 2. After School as Usual. 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. During the After School as Usual condition, participants will not receive any extra intervention, but will participate in data collection using the same procedures and methodologies as the intervention schools.
After School Plus. After School 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. Recruitment. Adolescents will be invited to participate in the study when they enroll in the afterschool program. The investigators will work closely with the site lead and teacher at each school assigned to help us with recruitment and retention. Adolescents can participate in the afterschool program without participating in the study (i.e., data collection).
Parents will need to provide written parental consent and students provide written assent before a student can enroll in the study. Because students can enroll in afterschool program at any time over the year, we will allow study enrollment on an ongoing basis through February 2025. Mentors will be recruited by emailing a description of the mentor opportunity to various student organizations and professors to share with their classes. This study targets courses with large class sizes. The study will also post flyers describing the opportunity across campus.
Promising candidates based on their application will be invited to group information sessions at which the research team observes their interactions in a group setting and provides information about the role. Interested candidates are asked to schedule a one- on-one interview. Mentors can receive class credit for mentoring. We previously used these strategies in the proof-of-concept study to recruit a diverse group of mentors, reflective of many majors and colleges. Data Collection. Primary data collection will include process data (e.g., attendance) and pre, midpoint, and post surveys (October, December, and April) among adolescents and mentors. Surveys will assess constructs including depressive symptoms, anxiety symptoms, behavioral activation, and emotion regulation. Additionally, approximately 75-80% of adolescent participants will provide accelerometry data to measure the amount and intensity of physical activity they do during the afterschool program
- Conditions
- Depression
- Being tested
- After School Plus
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After School PlusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: After School Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 8 months
Secondary outcomes (5)
Depression symptoms
Will be measured using PHQ-8
Measured: Baseline
Depression symptoms
Will be measured using PHQ-8
Measured: 4 months
Depression symptoms
Will be measured using PHQ-8
Measured: 8 months
Activity level in after school program
Accelerometry measured 2 days per semester at randomly selected intervals per class
Measured: 4 months
Activity level in after school program
Accelerometry measured 2 days per semester at randomly selected intervals per class
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start24 Sep 2024
- Primary completion17 Jun 2025
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Hendel, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686784
- Sponsor's protocol ID
- STUDY00020498
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Mentoring Afterschool Program to Improve Adolescent Mental Health and Physical Activity: A Pilot Study
- ClinicalTrials.gov ID
- NCT06686784
- Acronym / sponsor ID
- STUDY00020498
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 13 Nov 2024 (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.
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.
Detailed description
The proposed study builds from formative work in which the investigators developed an augmented version of an existing afterschool program in which college students are trained to mentor and assist in the afterschool program. Specifically, 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. The study will use a modified, quasi-experimental crossover pilot trial design (n= 1 schools; 1 Afterschool program as usual and 1 After School Plus) conducted in partnership with St. Paul Public School District's school-based afterschool programming, "Flipside". School A will receive After School Plus in semester 1 and After School as Usual in semester 2. School B will receive After School as Usual in semester 1 and After School Plus in Semester 2. After School as Usual. 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. During the After School as Usual condition, participants will not receive any extra intervention, but will participate in data collection using the same procedures and methodologies as the intervention schools.
After School Plus. After School 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. Recruitment. Adolescents will be invited to participate in the study when they enroll in the afterschool program. The investigators will work closely with the site lead and teacher at each school assigned to help us with recruitment and retention. Adolescents can participate in the afterschool program without participating in the study (i.e., data collection).
Parents will need to provide written parental consent and students provide written assent before a student can enroll in the study. Because students can enroll in afterschool program at any time over the year, we will allow study enrollment on an ongoing basis through February 2025. Mentors will be recruited by emailing a description of the mentor opportunity to various student organizations and professors to share with their classes. This study targets courses with large class sizes. The study will also post flyers describing the opportunity across campus.
Promising candidates based on their application will be invited to group information sessions at which the research team observes their interactions in a group setting and provides information about the role. Interested candidates are asked to schedule a one- on-one interview. Mentors can receive class credit for mentoring. We previously used these strategies in the proof-of-concept study to recruit a diverse group of mentors, reflective of many majors and colleges. Data Collection. Primary data collection will include process data (e.g., attendance) and pre, midpoint, and post surveys (October, December, and April) among adolescents and mentors. Surveys will assess constructs including depressive symptoms, anxiety symptoms, behavioral activation, and emotion regulation. Additionally, approximately 75-80% of adolescent participants will provide accelerometry data to measure the amount and intensity of physical activity they do during the afterschool program
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| School A | Experimental | Behavioral: After School PlusMiddle 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. |
| School B | Experimental | Behavioral: After School PlusMiddle 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. |
Who may qualify
- Ages
- 9 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Have a substantial cognitive impairment that would prevent the completion of data collection activities.
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 |
|---|---|---|
| After School PlusThe 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. | Behavioural | School A, School B |
Primary outcome
intervention feasibility
Time frame: 4 months
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)
intervention feasibility
Time frame: 8 months
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)
5 secondary outcomes
Depression symptoms
Time frame: Baseline
Depression symptoms
Time frame: 4 months
Depression symptoms
Time frame: 8 months
Activity level in after school program
Time frame: 4 months
Activity level in after school program
Time frame: 8 months
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 22 Apr 2026.
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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.
Katherine Hendel principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After School Plus in people with Depression, run by University of Minnesota at 1 site 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 0 inclusion and 1 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
intervention feasibility (time frame: 4 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?
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 22 Apr 2026.