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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 : Recruiting
First Posted : May 7, 2019
Last Update Posted : October 5, 2020
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 Suicidal Ideation 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
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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 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.



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 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         
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    
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: October 5, 2020
Last Verified: September 2020
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
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior