Study of Mental Health and Relationships
ConditionMental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-16
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Parental primary language other than English
Youth difficulties in cognitive functioning that would preclude ability to complete study assessments
Trial design
Design model
Parallel
Treatments tested in this trial
Great Life Mentoring
BehavioralThe 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Services as UsualNo intervention 0 interventions
Group B: GLM + Services as UsualExperimental treatment 1 intervention
Trial outcomes
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 years2
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 years3
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 years4
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 yearsSecondary 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 years2
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 year3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
Herrera Consulting Group, LLC
Collaborator
Source ClinicalTrials.gov