Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools

Not Applicable

Completed

Conditions: Suicidal Ideation
Depression

Registration Number: NCT03940508

Lead Sponsor: New York University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

Inclusion Criteria

Must identify as Black and/or African American
Must be enrolled in grades 6-12 (except 12th graders in their last semester)
Must be able to speak English
Must have received caregiver consent and have assented to participate
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
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

Actively suicidal with intent or plan
Intellectually disabled
Have a life threatening medical illness
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
Currently in active treatment for depression (excluding medication) at baseline assessment

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies-Depression Scale	Baseline	A 20-item self-report scale designed to measure depressive symptomatology in the general population. Scores range from 0 to 60, with higher scores indicating greater depression symptoms. 16 is a common clinical cutoff.
Hamilton Rating Scale for Depression	Baseline	Determines a patient's level of depression before, during, and after treatment. Scores range from 0 to 52, with higher scores indicating greater severity of depression. Scores of 0-7 indicate no depression.
Demographic Form	Baseline	To measure participants' demographic characteristics
Columbia-Suicide Severity Rating Scale	Baseline	To assess the severity and lethality of suicidal behaviors and ideations, and can be used to monitor treatment outcomes and establish suicide risk in a variety of research and clinical settings. "Yes" and "No" categories are used to determine suicide risk, with binary coding where No=0 and Yes=1 for items 1-5. The higher number indicating more intense ideation. Total scores of items 1-5 were analyzed, with the lowest score =0 and the highest score=5.
Barriers for Adolescents Seeking Health	Baseline	Self-report questionnaire that targets barriers to seeking professional psychological help. Scores range from 37 to 111, with higher scores indicating greater barriers to help seeking behaviors.
Penn Helping Alliance Revised	Week 4	This questionnaire collects data from both the therapist and patient to measure the strength of the bond between therapist and patient, called the therapeutic alliance. Scores range from 6 to 36, with a higher score indicating greater therapeutic alliance.
Child Help-Seeking Scale	Baseline	Self-report 28-item questionnaire designed to measure children's and adolescents' willingness to seek help for psychosocial problems from adults in the school setting. Scores for part one range from 16 to 64 and scores for part two rang from 7 to 28, with higher scores indicating less help- seeking.
Attitudes Toward Psychological Help Scale	Baseline	This scale assesses psychological factors, including stigma, perceived relevance of treatment, etc., that impact one's perceptions of and attitudes about using formal mental health treatment services. Scores range from 0-15, with higher scores indicating greater stigma.
Stages of Change	Baseline	32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy. The highest score among each sub-scale indicates which stage of change a person is in. Thus, sub-scale scores are reported. Sub-scale scores do not indicate a better or worse outcome; instead, higher scores indicate a readiness to take action to address mental health concerns on each sub-scale. Pre-contemplation scores range from 5-20, Contemplation scores range from 4-16, Action scores range from 5-20, and Maintenance scores range from 4-16.
Barriers to Treatment Participation Scale	Baseline	To test whether perceived barriers to treatment influence dropping out and other measures of participation in treatment. To assess a broad range of barriers evident over the course of treatment, including four thematic areas: stressors and obstacles that compete with treatment, treatment demands and issues, perceived relevance of treatment, and relationship with the therapist. Higher scores indicating greater barriers to treatment. Sub-scale scores range from 20 to 100 (Stressors), 10-50 (Demands), and 8-40 (Perceived Relevance of Treatment).
Understanding Mood Disorders Questionnaire	Baseline	Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders. Scores range from 9 to 40, with higher scores indicating less understanding of how depression presents and functions.
Therapy Survey	Baseline	To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions. Scores range from 7 to 35, with higher scores indicating misconceptions about the role of therapy.
Suicidal Ideation Questionnaire-Junior	Baseline	A 15-item self-report measure developed specifically for identifying and assessing current suicidal ideation among young adolescents that requires approximately five to eight minutes to complete. Scores range from 0 to 90, with a typical clinical cutoff score of 31 indicating further evaluation due to increased risk of suicidal ideation.
Global Assessment Scale for Children	Baseline	To reflect the lowest level of functioning for a child or adolescent during a specified time period, or on a hypothetical continuum of health-illness. Higher scores indicate higher functioning, ranging from 1-100.
Interpersonal Needs	Baseline	A 15-item questionnaire to measure changes in students' social connectedness and social competence. Total scores ranging from 15-99 are reported with higher scores indicated less social connectedness.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Columbia University
🇺🇸
New York, New York, United States
McSilver Institute for Poverty Policy and Research
🇺🇸
New York, New York, United States
Columbia University
🇺🇸New York, New York, United States