Study of Mental Health and Relationships

NCT06534827 | Recruiting

• 1 other identifier: 107309
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health

Keywords

mentoring; mental health; youth; low-income; mental health interventions

Outcome Measures

Primary Outcomes (11)

• 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

  Annually throughout duration of study participation, average of 2 years

• 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)

  Annually throughout duration of study participation, average of 2 years

• Anxiety Symptoms

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (33)

• Engagement in Mental Health Services

  End of study participation, average of 2 years

• Therapist-Youth Alliance

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

• Resilience

  Annually throughout duration of study participation, average of 2 years

• Adaptive Coping with Stress

  Annually throughout duration of study participation, average of 2 years

• Emotion Regulation

  Annually throughout duration of study participation, average of 2 years

Study Arms (2)

Services as Usual

NO INTERVENTION

Outpatient mental health services as usual

GLM + Services as Usual

EXPERIMENTAL

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

Great Life Mentoring BEHAVIORAL

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.

GLM + Services as Usual

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Herrera Consulting Group, LLC: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

RECRUITING

Related Links

• Website of Great Life Mentoring program

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• David DuBois, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David DuBois, PhD

CONTACT

312-413-9806; dldubois@uic.edu

Carla Herrera, PhD

CONTACT

202-765-4143; carlaherrera66@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: August 2, 2024
• Study Start: November 6, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)