Study of Mental Health and Relationships
NCT Number: NCT06534827
Acronym: SMART
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health
Interventions: BEHAVIORAL: Great Life Mentoring
Sponsor: University of Illinois at Chicago
Collaborators: Herrera Consulting Group, LLC
Sex: ALL
Age: CHILD
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-11-06
Completion Date: 2027-06-30
Locations: University of Illinois at Chicago, Chicago, Illinois, 60608, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Engagement in Mental Health Services, 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, 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, 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, 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, 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, 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), 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, Total score on measure from Pearlin \& Schooler (1978) (11 items, parent-report), Annually throughout duration of study participation, average of 2 years|Family Functioning, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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