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

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ClinicalTrials.gov Identifier: NCT03940508
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Columbia University
Information provided by (Responsible Party):
Michael A. Lindsey, 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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Making Connections Intervention Behavioral: IPT-A Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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.
Other Name: Interpersonal Psychotherapy for Depressed Adolescents

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.
Other Name: Interpersonal Psychotherapy for Depressed Adolescents




Primary Outcome Measures :
  1. Change in Caregiver Engagement (measured by the Birmingham Engagement Measure) [ Time Frame: Changes in engagement measured at weeks 8 & 12 from the date of randomization/week 1 through completion of the study (sessions 12 to 14). Sessions are held weekly from week 1 up to 25 weeks from randomization accounting for school absences. ]
    An 11 item measure with scores ranging from 11 (no engagement) to 55 (full engagement). Scores below 33 indicate progressively poorer engagement.

  2. Change in Adolescent Engagement (measured by the Reach Progress of Treatment Measure) [ Time Frame: Changes in engagement measured at weeks 1-14 from the date of randomization/week 1 through completion of the study (sessions 12 to 14). Sessions are held weekly from week 1 up to 25 weeks from randomization accounting for school absences. ]
    A six question completed by the therapist with a score range of 5 to 25, with higher scores indicating better client engagement with therapy.

  3. Change in Adolescent Depression (measured by the Hamilton Rating Scale for Depression/HRSD) [ Time Frame: Changes in depression measured at weeks 1, 4, 8 & 12 from the date of randomization/week 1 through completion of the study (sessions 12 to 14). Sessions are held weekly from week 1 up to 25 weeks from randomization accounting for school absences. ]
    Higher value indicate worse symptoms (0-6 absence or remission of depression, 7-17 mild depression, 18-24 moderate depression, 25+ severe depression).

  4. Change in Adolescent Depression (measured by the Center for Epidemiological Studies-Depression Scale/CES-D) [ Time Frame: Changes in depression measured at weeks 1, 4, 8 & 12 from the date of randomization/week 1 through completion of the study (sessions 12 to 14). Sessions are held weekly from week 1 up to 25 weeks from randomization accounting for school absences. ]
    Score range of 0-60, with higher scores indicating more symptoms. For the initial screening, adolescents must have a CES-D of score greater than 16 to be eligible.


Secondary Outcome Measures :
  1. Suicidal Ideation (measured by Suicidal Ideation Questionnaire-Junior/SIQ-JR) [ Time Frame: Changes in ideation measured at weeks 1, 4, 8 & 12 from the date of randomization/week 1 through completion of the study (sessions 12 to 14). Sessions are held weekly from week 1 up to 25 weeks from randomization accounting for school absences. ]
    A fifteen item self-report measure with higher scores indicating greater severity of suicidal ideation. A score of 31 or higher indicates a need for further clinical evaluation.

  2. Suicidal Ideation (measured by Columbia Suicide Severity Rating Scale/C-SSRS) [ Time Frame: Changes in ideation measured at weeks 1, 4, 8 & 12 from the date of randomization/week 1 through completion of the study (sessions 12 to 14). Sessions are held weekly from week 1 up to 25 weeks from randomization accounting for school absences. ]
    Score rage of 0-5, with 0 indicating no suicidal ideation.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940508


Contacts
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Contact: Michael A Lindsey, PhD (212) 998-5927 michael.lindsey@nyu.edu
Contact: Tracy M Grogan, MS (212) 992-6902 tmg374@nyu.edu

Locations
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United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10003
Contact: Laura Mufson, PhD    646-774-5791    Laura.Mufson@nyspi.columbia.edu   
Sub-Investigator: Laura Mufson, PhD         
McSilver Institute for Poverty Policy and Research Not yet recruiting
New York, New York, United States, 10003
Contact: Tracy M Grogan, MS    212-992-6902    tmg374@nyu.edu   
Contact: Michael A Lindsey, PhD    (212) 998-5927    michael.lindsey@nyu.edu   
Principal Investigator: Michael A Lindsey, PhD         
Astor Family Services Not yet recruiting
New York, New York, United States, 10467
Contact: Anne Rosenberg, LCSW    914-230-6134    arosenberg@astorservices.org   
Sponsors and Collaborators
New York University
National Institute of Mental Health (NIMH)
Columbia University
Investigators
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Principal Investigator: Michael A Lindsey, PhD NYU Silver School of Social Work
  Study Documents (Full-Text)

Documents provided by Michael A. Lindsey, New York University:
Study Protocol  [PDF] April 17, 2019


Additional Information:
Publications:

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Responsible Party: Michael A. Lindsey, Executive Director, McSilver Institute for Poverty Policy and Research, New York University
ClinicalTrials.gov Identifier: NCT03940508     History of Changes
Other Study ID Numbers: 1R34MH119290-01 ( U.S. NIH Grant/Contract )
1R34MH119290-01 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Submit data in compliance with NIMH Data Archive data submission agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: By the end of data collection, March 2022.
Access Criteria: In accordance with the NIMH Data Archive requirements.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael A. Lindsey, New York University:
depression
treatment engagement
adolescents
Black youth
Intervention

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicide
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior