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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03940508

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted October 5, 2020

Study Description

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.

  • Condition or Disease:Suicidal Ideation
    Depression
  • Intervention/Treatment: Behavioral: Making Connections Intervention
    Behavioral: IPT-A
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: MCI + IPT-A
Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression.
Behavioral: Making Connections Intervention
The MCI is a one to two session intervention that addresses barriers to mental health treatment and helps adolescents build skills to get the most out of their treatment experience. It is designed to be delivered by a trained clinician in conjunction with an evidence-based treatment.

Behavioral: IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Active Comparator: IPT-A Only
Participants will receive IPT-A for depression.
Behavioral: IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Outcome Measures
  • Primary Outcome Measures: 1. Change in Barriers for Adolescents Seeking Health (BASH) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    Self-report questionnaire that targets barriers to seeking professional psychological help
  • 2. Change in Child Help-Seeking Scale (HSS) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    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.
  • 3. Change in Attitudes Toward Psychological Help Scale (ATPHS) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    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.
  • 4. Change in Stages of Change (SOC) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy.
  • 5. Change in Penn Helping Alliance (Haq-R) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    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."
  • 6. MCI Integrity Scale (MCI) [ Time Frame: Week 1 ]
    To measure treatment integrity in Making Connections Intervention (MCI)
  • 7. Change in IPT-A Fidelity Form (IPT-A) [ Time Frame: From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks. ]
    To measure treatment integrity in IPT-A and maintain treatment effectiveness
  • 8. Change in Barriers to Treatment Participation Scale (BTPS) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    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.
  • 9. Understanding Mood Disorders Questionnaire (UMDQ) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders
  • 10. Therapy Survey (TS) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions.
  • 11. Change in Progress of Treatment (POT) [ Time Frame: From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks. ]
    To measure adolescent engagement in treatment in order to control for the common factors of psychotherapy.
  • 12. Change in Engagement Measure (EM) [ Time Frame: Week 8 and Week 12 ]
    An 11-item measures for engagement, which includes six dimensions: Appointment keeping (two items); Client-therapist interaction (one item); Communication/Openness (three items); Client's perceived usefulness of treatment (one item); Collaboration with treatment (three items) and Compliance with medication (one item)
  • 13. Change in Evidence-Based Practice Attitude Scale (EBPAS) [ Time Frame: Week 1, week 12 ]
    Assesses mental health service provider attitudes toward adopting evidence-based practices.
  • 14. Service use logs (SUL) [ Time Frame: From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks. ]
    Measures the change in attendance of treatment session by therapists.
  • 15. Termination form (TF) [ Time Frame: Week 12 ]
    Measures the termination of treatment session by therapists
  • 16. Change in Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Baseline, week 1, weeks 4, 8, 12 ]
    Determines a patient's level of depression before, during, and after treatment.
  • 17. Change in Center for Epidemiological Studies-Depression Scale (CES-DC) [ Time Frame: Screen, baseline, weeks 4,8,12 ]
    A 20-item self-report scale designed to measure depressive symptomatology in the general population.
  • 18. Change in Suicidal Ideation Questionnaire-Junior (SIQ-Jr) [ Time Frame: Baseline, weeks 4,8,12 ]
    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.
  • 19. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, weeks 4,8,12 ]
    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.
  • 20. Change in Global Assessment Scale for Children (C-GAS) [ Time Frame: Baseline, weeks 4,8,12 ]
    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.
  • 21. Change in Therapist Satisfaction Questionnaire (TSQ) [ Time Frame: Week 1, week 12 ]
    A 5-point questionnaire filled by therapists to indicate their satisfaction of the therapy (e.g., "the sense of comfort" and "nervousness").
  • 22. Demographic Form (DF) [ Time Frame: Baseline ]
    To measure participants' demographic characteristics
  • 23. School records (GL) [ Time Frame: Baseline ]
    To measure youth's school records
  • 24. Change in School Performance- GPA, Number of Suspensions, and School attendance (SP) [ Time Frame: Baseline, weeks 4, 8, 12 ]
    To measure students' school performance, number of suspensions, and school attendance.
  • 25. Change in Interpersonal Needs (INQ) [ Time Frame: Baseline, weeks 4, 8, 12 ]
    A 15-item questionnaire to measure changes in students' social connectedness and social competence.
Eligibility Criteria
  • Ages Eligible for Study: 12 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts

Contact: Michael A Lindsey, PhD (212) 998-5927 michael.lindsey@nyu.edu

Contact: Tracy M Grogan, MS (212) 992-6902 tmg374@nyu.edu

Locations

United States, New York
Columbia University
New York

United States, New York
McSilver Institute for Poverty Policy and Research
New York

Sponsors and Collaborators

New York University

National Institute of Mental Health (NIMH)

Columbia University

Investigators

Principal Investigator: Michael A Lindsey, PhD NYU Silver School of Social Work

More Information