- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06534827
Study of Mental Health and Relationships (SMART)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David DuBois, PhD
- Phone Number: 312-413-9806
- Email: dldubois@uic.edu
Study Contact Backup
- Name: Carla Herrera, PhD
- Phone Number: 202-765-4143
- Email: carlaherrera66@gmail.com
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60608
- Recruiting
- University of Illinois at Chicago
-
Contact:
- David L. DuBois, PhD
- Phone Number: 312-413-9806
- Email: dldubois@uic.edu
-
Contact:
- Julius Rivera, B.A.
- Phone Number: 312-996-4214
- Email: jriver40@uic.edu
-
Principal Investigator:
- David L. DuBois, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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
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|
|
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
|
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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
|
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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)
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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
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David DuBois, PhD, University of Illinois Chicago
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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