Study of Mental Health and Relationships (SMART)

August 20, 2025 updated by: David DuBois, University of Illinois at Chicago

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60608
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Contact:
        • Principal Investigator:
          • David L. DuBois, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Services as Usual
Outpatient mental health services as usual
Experimental: GLM + Services as Usual
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Mental Health
Time Frame: Annually throughout duration of study participation, average of 2 years

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

Annually throughout duration of study participation, average of 2 years
Depressive Symptoms
Time Frame: Annually throughout duration of study participation, average of 2 years
Total raw score on the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Short-Form v2.0 Depressive Symptoms (8 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Anxiety Symptoms
Time Frame: Annually throughout duration of study participation, average of 2 years
Total raw score on the PROMIS Pediatric Short-Form v2.0 Anxiety (8 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Loneliness
Time Frame: Annually throughout duration of study participation, average of 2 years
Total raw score on NIH (National Institutes of Health) Toolbox Loneliness Fixed Form Ages 8-17 v2.0 (7 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Internalizing Symptoms
Time Frame: Annually throughout duration of study participation, average of 2 years
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
Annually throughout duration of study participation, average of 2 years
Externalizing Symptoms
Time Frame: Annually throughout duration of study participation, average of 2 years
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
Annually throughout duration of study participation, average of 2 years
Life Satisfaction
Time Frame: Annually throughout duration of study participation,average of 2 years
Total score on Brief Multidimensional Students' Life Satisfaction Scale (6 items; youth self-report)
Annually throughout duration of study participation,average of 2 years
Happiness
Time Frame: Annually throughout duration of study participation, average of 2 years
Total raw score on PROMIS Pediatric Short Form v1.0 - Positive Affect 4a (4 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Suicidal Ideation
Time Frame: Annually throughout duration of study participation, average of 2 years
Affirmative response on Youth Risk Behavior Surveillance item asking about suicidal ideation, tailored to refer to the past year (youth self-report)
Annually throughout duration of study participation, average of 2 years
Self-esteem
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Global Self-Esteem scale of the short-form of the Self-Esteem Questionnaire (4 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Hope
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on abbreviated "Toolbox" version of the Hopeful Future Expectations Scale (7 items; youth self-report)
Annually throughout duration of study participation, average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement in Mental Health Services
Time Frame: End of study participation, average of 2 years
Percentage of scheduled mental health services sessions attended as indicated by mental health service records
End of study participation, average of 2 years
Therapist-Youth Alliance
Time Frame: Annually throughout duration of study participation while youth is receiving mental health services, average of 1 year
Average of standardized (z-scored) scores on therapist and youth report versions of the Therapist Alliance Scale for Children-Revised
Annually throughout duration of study participation while youth is receiving mental health services, average of 1 year
Resilience
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on The Resilience Scale (RS-14) (14 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Adaptive Coping with Stress
Time Frame: Annually throughout duration of study participation, average of 2 years
Rating on single-item youth-report measure adapted from Coping Efficacy Scale (Sandler et al., 2000)
Annually throughout duration of study participation, average of 2 years
Emotion Regulation
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on measure adapted from Prior et al. (2000) (4 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Empathy
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on measure used in evaluation by Boys and Girls Clubs of America (4 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Spark (hobby/interest)
Time Frame: Annually throughout duration of study participation, average of 2 years
Response on single item youth-report measure adapted from Search Institute Thriving Orientation Survey
Annually throughout duration of study participation, average of 2 years
Self-advocacy
Time Frame: Annually throughout duration of study participation,average of 2 years
Total score on Self-advocacy Scale from Mentoring Enhancement Demonstration Project (4 items; youth self-report)
Annually throughout duration of study participation,average of 2 years
Goal-setting
Time Frame: Annually throughout duration of study participation, average of 2 years
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)
Annually throughout duration of study participation, average of 2 years
Problem-solving
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Scale from Raising Healthy Children Survey (4 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Communication Skills
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on measure used in evaluation by Boys and Girls Clubs of America (4 items; youth self-report)
Annually throughout duration of study participation, average of 2 years
Grit - Perseverance
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Perseverance subscale of the Short Grit Scale for Children (4 items, youth self-report0
Annually throughout duration of study participation, average of 2 years
Peer Social Skills
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Social Competence Sale of the Youth Outcome Measures Toolbox (7 items, youth self-report)
Annually throughout duration of study participation, average of 2 years
Social Support from Family
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Family subscale of the Multidimensional Scale of Perceived Social Support (4 items, youth self-report)
Annually throughout duration of study participation, average of 2 years
Social Support from Non-Parental Adults
Time Frame: Annually throughout duration of study participation, average of 2 years
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)
Annually throughout duration of study participation, average of 2 years
Social Support from Peers
Time Frame: Annually throughout duration of study participation, average of 2 years
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)
Annually throughout duration of study participation, average of 2 years
Very Important Nonfamilial Adult
Time Frame: Annually throughout duration of study participation, average of 2 years
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.
Annually throughout duration of study participation, average of 2 years
Academic Success
Time Frame: Annually throughout duration of study participation, average of 2 years
Response on single item from DuBois et al. (2022) asking about grades in school (youth self-report)
Annually throughout duration of study participation, average of 2 years
School Connectedness
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on School subscale of Hemingway Measure of Adolescent Connectedness (6 items, youth self-report)
Annually throughout duration of study participation, average of 2 years
Career Exploration
Time Frame: Annually throughout duration of study participation, average of 2 years
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)
Annually throughout duration of study participation, average of 2 years
Perceptions of Treatment Progress
Time Frame: Annually throughout duration of study participation, average of 2 years
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)
Annually throughout duration of study participation, average of 2 years
Perceptions of Counseling Impact
Time Frame: Annually throughout duration of study participation while youth is receiving mental health services, average of 1 year
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)
Annually throughout duration of study participation while youth is receiving mental health services, average of 1 year
Parent Stress
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on measure from Pearlin & Schooler (1978) (11 items, parent-report)
Annually throughout duration of study participation, average of 2 years
Family Functioning
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on General Functioning subscale of the Family Assessment Device (Epstein et al., 1983) (12 items, parent-report)
Annually throughout duration of study participation, average of 2 years
Positive Parenting
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Positive Parenting subscale of the Alabama Parenting Questionnaire (6 items, parent-report)
Annually throughout duration of study participation, average of 2 years
Parental Involvement
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Involvement subscale of the Alabama Parenting Questionnaire (10 items, parent-report)
Annually throughout duration of study participation, average of 2 years
Parental Poor Supervision
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Poor Monitoring/Supervision subscale of the Alabama Parenting Questionnaire (10 items, parent-report)
Annually throughout duration of study participation, average of 2 years
Self-Control
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on Child Self-Control scale (Grasmick et al., 1993) (8 items, parent-report)
Annually throughout duration of study participation, average of 2 years
Social-emotional Learning Skills
Time Frame: Annually throughout duration of study participation, average of 2 years
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)
Annually throughout duration of study participation, average of 2 years
Parent Depressive Symptoms
Time Frame: Annually throughout duration of study participation, average of 2 years
Total raw score on PROMIS Short Form v1.0 - Depression 4a (4 items, parent self-report)
Annually throughout duration of study participation, average of 2 years
Parent Positive Affect
Time Frame: Annually throughout duration of study participation, average of 2 years
Total raw score on PROMIS Pediatric Short Form v1.0 - Positive Affect 4a (4 items; parent self-report)
Annually throughout duration of study participation, average of 2 years
Parent-Child Alliance
Time Frame: Annually throughout duration of study participation, average of 2 years
Total score on measure from the National Survey of Children's Health (5 items; parent report)
Annually throughout duration of study participation, average of 2 years
Successful Completion of Treatment
Time Frame: Point in time when youth's mental health treatment ends, average of 1 year
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.
Point in time when youth's mental health treatment ends, average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David DuBois, PhD, University of Illinois Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 107309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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