ClinicalTrials.gg
RecruitingNCT06534827SMARTUpdated Nov 12, 2026

Study of Mental Health and Relationships

An interventional study of Great Life Mentoring in Mental Health, sponsored by University of Illinois Chicago. Recruiting at 1 site in United States. Open to participants aged 9 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Illinois Chicago · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2023, registered Mar 2024).
  • Started Nov 2023; still recruiting 3 years later.
Updated Nov 12, 2026Sponsor changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
9 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 654 studies in Psychological Well-Being with a site in United States — 188 open to participants now, 239 under way, 1 of them phase 3. Psychological Well-Being · United States.

Planned enrollment
209th of 572
180 · median 116
Started
2023
with 58 others
No phase
514 of 654
152 open now
Primary completion
2027-06
later than 119 of 237 live
Registered
433rd of 654
by date

Among the 654 studies in Psychological Well-Being with a site in United States, this one is the 209th largest by planned enrollment of the 572 interventional ones that give a count, is one of 59 that started in 2023, is one of 514 with no phase, reaches primary completion later than 119 of the 237 other live ones, and was the 433rd registered.

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

188 of the 654 studies in Psychological Well-Being with a site in United States are open now. Recruiting first, the newest first:

183 more — sign in →

All 188 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 9 Years to 16 Years · all sexes · healthy volunteers too.

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02

Study 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. 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.
03

Conditions studied

  • Mental Health

Keywords

  • mentoring
  • mental health
  • youth
  • low-income
  • mental health interventions
04

Who can participate

Ages eligible
9 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Parental primary language other than English
  • Youth difficulties in cognitive functioning that would preclude ability to complete study assessments
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • 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.

    Behavioral: Great Life Mentoring

Interventions

  • BehavioralGreat Life Mentoring

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Annually throughout duration of study participation, average of 2 years

Secondary outcomes

  1. Engagement in Mental Health Services

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 43 months after the start.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 43 months is above that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2024
First posted
Aug 2, 2024
StartActual
Nov 6, 2023
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sponsor
University of Illinois at Chicago→University of Illinois Chicago
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Sponsor University of Illinois at Chicago→University of Illinois Chicago
    + 3 other changes: identifiers, verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06534827
Lead sponsor
University of Illinois Chicago
Collaborators
Herrera Consulting Group, LLC
Responsible party
David DuBois (Professor Emeritus, University of Illinois Chicago) — Principal investigator
First posted
Aug 2, 2024
Start date
Nov 6, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

David DuBois, PhD
Contact
dldubois@uic.edu
312-413-9806
Carla Herrera, PhD
Contact
carlaherrera66@gmail.com
202-765-4143
David DuBois, PhD
principal investigator · University of Illinois Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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