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Mental HealthSMARTNCT06534827

Study of Mental Health and Relationships

A study testing Great Life Mentoring in people with Mental Health, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to test effects of the Great Life Mentoring (GLM) program on the mental health and adaptive functioning on school-age youth (ages 9-16) from low-income families who are receiving outpatient mental health services. Read more about this study

Who is it for?
Ages 9 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
Great Life Mentoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
6 Nov 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Youth is between 9- and 16-years-old
  • Youth meets eligibility criteria for the Great Life Mentoring program, which include receiving publically-subsidized outpatient mental health care

Who cannot join

  • Parental primary language other than English
  • Youth difficulties in cognitive functioning that would preclude ability to complete study assessments

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David DuBois, PhD contact

312-413-9806

dldubois@uic.edu

Carla Herrera, PhD contact

202-765-4143

carlaherrera66@gmail.com

United States1 site, 1 recruiting
  • University of Illinois at Chicago

    Chicago, Illinois, 60608

    David L. DuBois, PhD, 312-413-9806, dldubois@uic.edu

    Julius Rivera, B.A., 312-996-4214, jriver40@uic.edu

    Recruiting

Other trials in United States

About this study

Official title: Investigating an Innovative Mentoring Model for Improving Effectiveness and Equity of Community-Based Support for Youth From Low-Resource Families With Mental Health Challenges

The goal of this clinical trial is to test effects of the Great Life Mentoring (GLM) program on the mental health and adaptive functioning on school-age youth (ages 9-16) from low-income families who are receiving outpatient mental health services. The main questions it aims to answer are:

  • Does participation in the GLM program improve mental health and related outcomes among school-age youth (9- to 16-years-old) from low-income families as an adjunct to outpatient mental health services? 180 youth will be enrolled in the study and assigned randomly to either continue mental health services as usual (SAU) or to continue mental health services while also participating in GLM (SAU+GLM). Participating youth, and their parent/guardians and therapists, will be surveyed annually. Mental health services records also will be obtained with appropriate permissions. . Researchers will compare the SAU and SAU+GLM groups to see if participation in GLM has an effect on the mental health and related outcomes of study youth.
Conditions
Mental Health
Being tested
Great Life Mentoring
Keywords
mentoring, mental health, youth, low-income, mental health interventions
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Great Life MentoringBehavioural

    The Great Life Mentoring program (GLM) provides volunteer-based mentoring for school-age youth from low-resource families who are receiving outpatient mental health care. Each youth is paired with a mentor with whom they spend time in the community on a weekly basis for at least one year. Mentors are required to complete a 20-hour intensive training prior to being paired with a youth. Mentors also receive monthly in-person supervision from GLM staff for the first year of their meetings, which continues on an as-needed basis thereafter. Training and supervision are geared toward the unique opportunities and challenges that can occur when mentoring a youth with mental health needs. The goal is for the mentor to become an integral part of the child's mental health treatment, but the mentoring relationship is also sustained after treatment ends.

Study groups in NCT06534827
Study groupRoleWhat they receive
Services as UsualNo interventionOutpatient mental health services as usual
GLM + Services as UsualExperimentalThe Great Life Mentoring program (GLM) provides volunteer-based mentoring for school-age youth from low-resource families who are receiving outpatient mental health care. Each youth is paired with a mentor with whom they spend time in the community on a weekly basis for at least one year. Mentors are required to complete a 20-hour intensive training prior to being paired with a youth. Mentors also receive monthly in-person supervision from GLM staff for the first year of their meetings, which continues on an as-needed basis thereafter. Training and supervision are geared toward the unique opportunities and challenges that can occur when mentoring a youth with mental health needs. The goal is for the mentor to become an integral part of the child's mental health treatment, but the mentoring relationship is also sustained after treatment ends.
Receives: Behavioral: Great Life Mentoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Mental Health

    Average of standardized (z-scored) scores on following study outcome measures:

    Depressive Symptoms (inverted), Anxiety Symptoms (inverted), Loneliness (inverted), Internalizing Symptoms (inverted), Externalizing Symptoms (inverted), Suicidal Ideation, Happiness, Life Satisfaction, Self-Esteem, and Hope

    Measured: Annually throughout duration of study participation, average of 2 years

  2. Depressive Symptoms

    Total raw score on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Short-Form v2.0 Depressive Symptoms (8 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  3. Anxiety Symptoms

    Total raw score on the PROMIS Pediatric Short-Form v2.0 Anxiety (8 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  4. Loneliness

    Total raw score on NIH (National Institutes of Health) Toolbox Loneliness Fixed Form Ages 8-17 v2.0 (7 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  5. Internalizing Symptoms

    Average of standardized (z-scored) Total scores on the Internalizing scale of the youth self-report and parent-report versions of the Symptoms and Functioning Severity Scale (SFSS) - Peabody Treatment Progress Inventory

    Measured: Annually throughout duration of study participation, average of 2 years

  6. Externalizing Symptoms

    Average of standardized (z-scored) Total scores on the Externalizing scale of the youth self-report and parent report versions of the Symptoms and Functioning Severity Scale (SFSS) - Peabody Treatment Progress Inventory

    Measured: Annually throughout duration of study participation, average of 2 years

  7. Life Satisfaction

    Total score on Brief Multidimensional Students' Life Satisfaction Scale (6 items; youth self-report)

    Measured: Annually throughout duration of study participation,average of 2 years

  8. Happiness

    Total raw score on PROMIS Pediatric Short Form v1.0 - Positive Affect 4a (4 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  9. Suicidal Ideation

    Affirmative response on Youth Risk Behavior Surveillance item asking about suicidal ideation, tailored to refer to the past year (youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  10. Self-esteem

    Total score on Global Self-Esteem scale of the short-form of the Self-Esteem Questionnaire (4 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  11. Hope

    Total score on abbreviated "Toolbox" version of the Hopeful Future Expectations Scale (7 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

Secondary outcomes (33)
  1. Engagement in Mental Health Services

    Percentage of scheduled mental health services sessions attended as indicated by mental health service records

    Measured: End of study participation, average of 2 years

  2. Therapist-Youth Alliance

    Average of standardized (z-scored) scores on therapist and youth report versions of the Therapist Alliance Scale for Children-Revised

    Measured: Annually throughout duration of study participation while youth is receiving mental health services, average of 1 year

  3. Resilience

    Total score on The Resilience Scale (RS-14) (14 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  4. Adaptive Coping with Stress

    Rating on single-item youth-report measure adapted from Coping Efficacy Scale (Sandler et al., 2000)

    Measured: Annually throughout duration of study participation, average of 2 years

  5. Emotion Regulation

    Total score on measure adapted from Prior et al. (2000) (4 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  6. Empathy

    Total score on measure used in evaluation by Boys and Girls Clubs of America (4 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  7. Spark (hobby/interest)

    Response on single item youth-report measure adapted from Search Institute Thriving Orientation Survey

    Measured: Annually throughout duration of study participation, average of 2 years

  8. Self-advocacy

    Total score on Self-advocacy Scale from Mentoring Enhancement Demonstration Project (4 items; youth self-report)

    Measured: Annually throughout duration of study participation,average of 2 years

  9. Goal-setting

    Average of standardized (z-scored) Total scores on Goal-setting scale from Kuperminc et al. (2011) (4 items; youth self-report) and the Goal Orientation Scale (Child Trends, 2022) (7 items, parent report)

    Measured: Annually throughout duration of study participation, average of 2 years

  10. Problem-solving

    Total score on Scale from Raising Healthy Children Survey (4 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  11. Communication Skills

    Total score on measure used in evaluation by Boys and Girls Clubs of America (4 items; youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  12. Grit - Perseverance

    Total score on Perseverance subscale of the Short Grit Scale for Children (4 items, youth self-report0

    Measured: Annually throughout duration of study participation, average of 2 years

  13. Peer Social Skills

    Total score on Social Competence Sale of the Youth Outcome Measures Toolbox (7 items, youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  14. Social Support from Family

    Total score on Family subscale of the Multidimensional Scale of Perceived Social Support (4 items, youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  15. Social Support from Non-Parental Adults

    Total score on Special Persons subscale of the Multidimensional Scale of Perceived Social Support with items modified to refer to "special adult outside of my family" rather than "special person" (4 items, youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  16. Social Support from Peers

    Response on a single item developed for this study asking about whether the youth has a good friend around the same age (youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  17. Very Important Nonfamilial Adult

    Response on single item from DuBois et al. (2022) asking whether the youth has a very important adult in their life and, if so, in what category(ies), with endorsement of a category other than parent/primary caregiver or relative scored as 1 and other responses scored as 0. Other responses will be coded for applicability to the predetermined categories by persons blind to study arm.

    Measured: Annually throughout duration of study participation, average of 2 years

  18. Academic Success

    Response on single item from DuBois et al. (2022) asking about grades in school (youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  19. School Connectedness

    Total score on School subscale of Hemingway Measure of Adolescent Connectedness (6 items, youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  20. Career Exploration

    Total score on Future Planning: Talk to an Adult scale from the SAYO (Survey of Academic and Youth Outcomes)-Y (4 items, youth self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  21. Perceptions of Treatment Progress

    Average of standardized (z-scores) Total scores on youth- and parent-report versions Treatment Outcome Expectations Scale from the Peabody Treatment Progress Battery, with items modified to also refer to progress currently observed, not only expected (8 items)

    Measured: Annually throughout duration of study participation, average of 2 years

  22. Perceptions of Counseling Impact

    Total score on adapted version of the Youth Counseling Impact Scale from the Peabody Treatment Progress Battery, with items modified to refer to last 2 weeks rather than a single session, 2 items added, and 3 items dropped (5 items)

    Measured: Annually throughout duration of study participation while youth is receiving mental health services, average of 1 year

  23. Parent Stress

    Total score on measure from Pearlin \& Schooler (1978) (11 items, parent-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  24. Family Functioning

    Total score on General Functioning subscale of the Family Assessment Device (Epstein et al., 1983) (12 items, parent-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  25. Positive Parenting

    Total score on Positive Parenting subscale of the Alabama Parenting Questionnaire (6 items, parent-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  26. Parental Involvement

    Total score on Involvement subscale of the Alabama Parenting Questionnaire (10 items, parent-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  27. Parental Poor Supervision

    Total score on Poor Monitoring/Supervision subscale of the Alabama Parenting Questionnaire (10 items, parent-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  28. Self-Control

    Total score on Child Self-Control scale (Grasmick et al., 1993) (8 items, parent-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  29. Social-emotional Learning Skills

    Total score on measure of student social and emotional competencies (Collaborative for Academic, Social, and Emotional Learning \& the American Institutes for Research, 2013) (20 items, parent report)

    Measured: Annually throughout duration of study participation, average of 2 years

  30. Parent Depressive Symptoms

    Total raw score on PROMIS Short Form v1.0 - Depression 4a (4 items, parent self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  31. Parent Positive Affect

    Total raw score on PROMIS Pediatric Short Form v1.0 - Positive Affect 4a (4 items; parent self-report)

    Measured: Annually throughout duration of study participation, average of 2 years

  32. Parent-Child Alliance

    Total score on measure from the National Survey of Children's Health (5 items; parent report)

    Measured: Annually throughout duration of study participation, average of 2 years

  33. Successful Completion of Treatment

    Planned ending of treatment as determined by mental health records coded as 1 and unplanned, client-initiated ending, and endings for other reasons coded as 0.

    Measured: Point in time when youth's mental health treatment ends, average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start6 Nov 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534827
Sponsor's protocol ID
107309
Acronym
SMART
Status last verified
Sep 2026
First submitted
1 Mar 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Great Life Mentoring in people with Mental Health, run by University of Illinois Chicago 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Sep 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David DuBois, PhD (312-413-9806, dldubois@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Mental Health (time frame: Annually throughout duration of study participation, average of 2 years). The study lists 11 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 21 Sep 2026.

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