Clinical trial NCT03940508: Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools
Official title: Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Keywords: depression
treatment engagement
adolescents
Black youth
Intervention
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Columbia University
First posted: 2019-05-07
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. The investigators will examine the effectiveness of the Making Connections Intervention (MCI) and investigate key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products.

This study will address an important public health issue: How best to connect Black adolescents with depression to treatment in clinically meaningful ways, and how best to deliver evidence-based treatment to them through school-based services.

Detailed description: Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. Their rates of participation in treatments for depression are lower due to negative perceptions of services and providers, and their reluctance to acknowledge the presence of symptoms.

If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. This research examines the effectiveness of the Making Connections Intervention (MCI) and investigates key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products.

The investigators previously performed a small pilot study that used the MCI as an add-on to the IPT-A, an evidence-based intervention for depression delivered in schools typically over 12 sessions. The results suggested that MCI has a positive impact on many aspects of change associated with treatment engagement and clinical outcomes.

This study will be a randomized controlled trial. It will examine the effectiveness of the MCI in a multi-school trial involving adolescents in grades 6-12 who attend New York City (NYC) Department of Education (DOE) Public Schools. The investigators will randomly assign 60 Black students with depression symptoms to two conditions: MCI+IPT-A vs. IPT-A-alone. The investigators will also do qualitative research, like interviews, before the digital content is created. This will enhance the relevance of the MCI. The main outcomes are adolescent-and caregiver-level engagement and adolescent depression. Suicidal ideation is a secondary outcome. This study will also test related factors, like adolescent helping-seeking behavior and parental knowledge of mental health services, that can account for treatment outcomes and that will allow the MCI to be strengthened in future roll-outs of the intervention in school settings.

Eligibility criteria: Inclusion Criteria:

1. Must identify as Black and/or African American
2. Must be enrolled in grades 6-12 (except 12th graders in their last semester)
3. Must be able to speak English
4. Must have received caregiver consent and have assented to participate
5. Must meet depression and global functioning levels indicated by a CES-D score ≥16, a Hamilton Rating Scale of Depression (HRSD) Score ≥ 10, and a Global Assessment Scale for Children (C-GAS) score ≤ 65 at baseline
6. Students who are currently on a stable dose of anti-depressant medication, but still meet inclusion criteria, can be enrolled in the study.

Exclusion Criteria:

1. Actively suicidal with intent or plan
2. Intellectually disabled
3. Have a life threatening medical illness
4. Have a current primary substance abuse diagnosis in the moderate to severe range, schizophrenia, bipolar disorder, any evidence of psychosis, a primary diagnosis of anorexia
5. Currently in active treatment for depression (excluding medication) at baseline assessment

Primary outcomes:
measure: Change in Barriers for Adolescents Seeking Health (BASH)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Change in Child Help-Seeking Scale (HSS)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Change in Attitudes Toward Psychological Help Scale (ATPHS)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Change in Stages of Change (SOC)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Change in Penn Helping Alliance (Haq-R)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: MCI Integrity Scale (MCI)
timeFrame: Week 1
measure: Change in IPT-A Fidelity Form (IPT-A)
timeFrame: From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
measure: Change in Barriers to Treatment Participation Scale (BTPS)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Understanding Mood Disorders Questionnaire (UMDQ)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Therapy Survey (TS)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Change in Progress of Treatment (POT)
timeFrame: From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
measure: Change in Engagement Measure (EM)
timeFrame: Week 8 and Week 12
measure: Change in Evidence-Based Practice Attitude Scale (EBPAS)
timeFrame: Week 1, week 12
measure: Service use logs (SUL)
timeFrame: From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
measure: Termination form (TF)
timeFrame: Week 12
measure: Change in Hamilton Rating Scale for Depression (HRSD)
timeFrame: Baseline, week 1, weeks 4, 8, 12
measure: Change in Center for Epidemiological Studies-Depression Scale (CES-DC)
timeFrame: Screen, baseline, weeks 4,8,12
measure: Change in Suicidal Ideation Questionnaire-Junior (SIQ-Jr)
timeFrame: Baseline, weeks 4,8,12
measure: Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, weeks 4,8,12
measure: Change in Global Assessment Scale for Children (C-GAS)
timeFrame: Baseline, weeks 4,8,12
measure: Change in Therapist Satisfaction Questionnaire (TSQ)
timeFrame: Week 1, week 12
measure: Demographic Form (DF)
timeFrame: Baseline
measure: School records (GL)
timeFrame: Baseline
measure: Change in School Performance- GPA, Number of Suspensions, and School attendance (SP)
timeFrame: Baseline, weeks 4, 8, 12
measure: Change in Interpersonal Needs (INQ)
timeFrame: Baseline, weeks 4, 8, 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: McSilver Institute for Poverty Policy and Research
state: New York
Study officials:
affiliation: NYU Silver School of Social Work
name: Michael A Lindsey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunlicks-Stoessel M, Mufson L, Jekal A, Turner JB. The impact of perceived interpersonal functioning on treatment for adolescent depression: IPT-A versus treatment as usual in school-based health clinics. J Consult Clin Psychol. 2010 Apr;78(2):260-7. doi: 10.1037/a0018935.
citation: Mufson L, Moreau D, Weissman MM, Wickramaratne P, Martin J, Samoilov A. Modification of interpersonal psychotherapy with depressed adolescents (IPT-A): phase I and II studies. J Am Acad Child Adolesc Psychiatry. 1994 Jun;33(5):695-705. doi: 10.1097/00004583-199406000-00011.
citation: Mufson LH, Dorta KP, Olfson M, Weissman MM, Hoagwood K. Effectiveness research: transporting interpersonal psychotherapy for depressed adolescents (IPT-A) from the lab to school-based health clinics. Clin Child Fam Psychol Rev. 2004 Dec;7(4):251-61. doi: 10.1007/s10567-004-6089-6.
citation: Lindsey MA, Chambers K, Pohle C, Beall P, Lucksted A. Understanding the Behavioral Determinants of Mental Health Service Use by Urban, Under-Resourced Black Youth: Adolescent and Caregiver Perspectives. J Child Fam Stud. 2013 Jan 1;22(1):107-121. doi: 10.1007/s10826-012-9668-z. Epub 2012 Oct 16.
citation: Lindsey MA, Joe S, Nebbitt V. Family Matters: The Role of Mental Health Stigma and Social Support on Depressive Symptoms and Subsequent Help Seeking Among African American Boys. J Black Psychol. 2010 Nov 1;36(4):458-482. doi: 10.1177/0095798409355796.
citation: Breland-Noble AM, Bell CC, Burriss A; AAKOMA Project Adult Advisory Board. "Mama just won't accept this": adult perspectives on engaging depressed African American teens in clinical research and treatment. J Clin Psychol Med Settings. 2011 Sep;18(3):225-34. doi: 10.1007/s10880-011-9235-6.
citation: Lindsey MA, Korr WS, Broitman M, Bone L, Green A, Leaf PJ. Help-seeking behaviors and depression among African American adolescent boys. Soc Work. 2006 Jan;51(1):49-58. doi: 10.1093/sw/51.1.49.
citation: Lindsey MA, Brown DR, Cunningham M. Boys do(n't) cry: Addressing the unmet mental health needs of African American boys. Am J Orthopsychiatry. 2017;87(4):377-383. doi: 10.1037/ort0000198.
citation: Ellis ML, Lindsey MA, Barker ED, Boxmeyer CL, Lochman JE. Predictors of engagement in a school-based family preventive intervention for youth experiencing behavioral difficulties. Prev Sci. 2013 Oct;14(5):457-67. doi: 10.1007/s11121-012-0319-9.