Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools
Primary Purpose
Depression, Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Making Connections Intervention
IPT-A
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, treatment engagement, adolescents, Black youth, Intervention
Eligibility Criteria
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
Sites / Locations
- Columbia University
- McSilver Institute for Poverty Policy and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MCI + IPT-A
IPT-A Only
Arm Description
Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression.
Participants will receive IPT-A for depression.
Outcomes
Primary Outcome Measures
Change in Barriers for Adolescents Seeking Health (BASH)
Self-report questionnaire that targets barriers to seeking professional psychological help
Change in Child Help-Seeking Scale (HSS)
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.
Change in Attitudes Toward Psychological Help Scale (ATPHS)
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.
Change in Stages of Change (SOC)
32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy.
Change in Penn Helping Alliance (Haq-R)
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."
MCI Integrity Scale (MCI)
To measure treatment integrity in Making Connections Intervention (MCI)
Change in IPT-A Fidelity Form (IPT-A)
To measure treatment integrity in IPT-A and maintain treatment effectiveness
Change in Barriers to Treatment Participation Scale (BTPS)
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.
Understanding Mood Disorders Questionnaire (UMDQ)
Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders
Therapy Survey (TS)
To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions.
Change in Progress of Treatment (POT)
To measure adolescent engagement in treatment in order to control for the common factors of psychotherapy.
Change in Engagement Measure (EM)
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)
Change in Evidence-Based Practice Attitude Scale (EBPAS)
Assesses mental health service provider attitudes toward adopting evidence-based practices.
Service use logs (SUL)
Measures the change in attendance of treatment session by therapists.
Termination form (TF)
Measures the termination of treatment session by therapists
Change in Hamilton Rating Scale for Depression (HRSD)
Determines a patient's level of depression before, during, and after treatment.
Change in Center for Epidemiological Studies-Depression Scale (CES-DC)
A 20-item self-report scale designed to measure depressive symptomatology in the general population.
Change in Suicidal Ideation Questionnaire-Junior (SIQ-Jr)
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.
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Change in Global Assessment Scale for Children (C-GAS)
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.
Change in Therapist Satisfaction Questionnaire (TSQ)
A 5-point questionnaire filled by therapists to indicate their satisfaction of the therapy (e.g., "the sense of comfort" and "nervousness").
Demographic Form (DF)
To measure participants' demographic characteristics
School records (GL)
To measure youth's school records
Change in School Performance- GPA, Number of Suspensions, and School attendance (SP)
To measure students' school performance, number of suspensions, and school attendance.
Change in Interpersonal Needs (INQ)
A 15-item questionnaire to measure changes in students' social connectedness and social competence.
Secondary Outcome Measures
Full Information
NCT ID
NCT03940508
First Posted
April 29, 2019
Last Updated
September 22, 2023
Sponsor
New York University
Collaborators
National Institute of Mental Health (NIMH), Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT03940508
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
National Institute of Mental Health (NIMH), Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation
Keywords
depression, treatment engagement, adolescents, Black youth, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MCI + IPT-A
Arm Type
Experimental
Arm Description
Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression.
Arm Title
IPT-A Only
Arm Type
Active Comparator
Arm Description
Participants will receive IPT-A for depression.
Intervention Type
Behavioral
Intervention Name(s)
Making Connections Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IPT-A
Other Intervention Name(s)
Interpersonal Psychotherapy for Depressed Adolescents
Intervention Description
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Primary Outcome Measure Information:
Title
Change in Barriers for Adolescents Seeking Health (BASH)
Description
Self-report questionnaire that targets barriers to seeking professional psychological help
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Change in Child Help-Seeking Scale (HSS)
Description
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.
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Change in Attitudes Toward Psychological Help Scale (ATPHS)
Description
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.
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Change in Stages of Change (SOC)
Description
32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy.
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Change in Penn Helping Alliance (Haq-R)
Description
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."
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
MCI Integrity Scale (MCI)
Description
To measure treatment integrity in Making Connections Intervention (MCI)
Time Frame
Week 1
Title
Change in IPT-A Fidelity Form (IPT-A)
Description
To measure treatment integrity in IPT-A and maintain treatment effectiveness
Time Frame
From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
Title
Change in Barriers to Treatment Participation Scale (BTPS)
Description
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.
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Understanding Mood Disorders Questionnaire (UMDQ)
Description
Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Therapy Survey (TS)
Description
To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions.
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Change in Progress of Treatment (POT)
Description
To measure adolescent engagement in treatment in order to control for the common factors of psychotherapy.
Time Frame
From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
Title
Change in Engagement Measure (EM)
Description
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)
Time Frame
Week 8 and Week 12
Title
Change in Evidence-Based Practice Attitude Scale (EBPAS)
Description
Assesses mental health service provider attitudes toward adopting evidence-based practices.
Time Frame
Week 1, week 12
Title
Service use logs (SUL)
Description
Measures the change in attendance of treatment session by therapists.
Time Frame
From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
Title
Termination form (TF)
Description
Measures the termination of treatment session by therapists
Time Frame
Week 12
Title
Change in Hamilton Rating Scale for Depression (HRSD)
Description
Determines a patient's level of depression before, during, and after treatment.
Time Frame
Baseline, week 1, weeks 4, 8, 12
Title
Change in Center for Epidemiological Studies-Depression Scale (CES-DC)
Description
A 20-item self-report scale designed to measure depressive symptomatology in the general population.
Time Frame
Screen, baseline, weeks 4,8,12
Title
Change in Suicidal Ideation Questionnaire-Junior (SIQ-Jr)
Description
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.
Time Frame
Baseline, weeks 4,8,12
Title
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
Baseline, weeks 4,8,12
Title
Change in Global Assessment Scale for Children (C-GAS)
Description
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.
Time Frame
Baseline, weeks 4,8,12
Title
Change in Therapist Satisfaction Questionnaire (TSQ)
Description
A 5-point questionnaire filled by therapists to indicate their satisfaction of the therapy (e.g., "the sense of comfort" and "nervousness").
Time Frame
Week 1, week 12
Title
Demographic Form (DF)
Description
To measure participants' demographic characteristics
Time Frame
Baseline
Title
School records (GL)
Description
To measure youth's school records
Time Frame
Baseline
Title
Change in School Performance- GPA, Number of Suspensions, and School attendance (SP)
Description
To measure students' school performance, number of suspensions, and school attendance.
Time Frame
Baseline, weeks 4, 8, 12
Title
Change in Interpersonal Needs (INQ)
Description
A 15-item questionnaire to measure changes in students' social connectedness and social competence.
Time Frame
Baseline, weeks 4, 8, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Lindsey, PhD
Phone
(212) 998-5927
Email
michael.lindsey@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy M Grogan, MS
Phone
(212) 992-6902
Email
tmg374@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Lindsey, PhD
Organizational Affiliation
NYU Silver School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Mufson, PhD
Phone
646-774-5791
Email
Laura.Mufson@nyspi.columbia.edu
First Name & Middle Initial & Last Name & Degree
Laura Mufson, PhD
Facility Name
McSilver Institute for Poverty Policy and Research
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy M Grogan, MS
Phone
212-992-6902
Email
tmg374@nyu.edu
First Name & Middle Initial & Last Name & Degree
Michael A Lindsey, PhD
Phone
(212) 998-5927
Email
michael.lindsey@nyu.edu
First Name & Middle Initial & Last Name & Degree
Michael A Lindsey, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Submit data in compliance with NIMH Data Archive data submission agreement.
IPD Sharing Time Frame
By the end of data collection, December 2023.
IPD Sharing Access Criteria
In accordance with the NIMH Data Archive requirements.
Citations:
PubMed Identifier
20350036
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.
Results Reference
background
PubMed Identifier
8056733
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.
Results Reference
background
PubMed Identifier
15648279
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.
Results Reference
background
PubMed Identifier
23355768
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.
Results Reference
background
PubMed Identifier
20953336
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.
Results Reference
background
PubMed Identifier
21512751
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.
Results Reference
background
PubMed Identifier
16512510
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.
Results Reference
background
PubMed Identifier
28691838
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.
Results Reference
background
PubMed Identifier
23420474
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.
Results Reference
background
Links:
URL
https://nyuscholars.nyu.edu/en/publications/psychometric-properties-of-the-center-for-epidemiological-studies
Description
Lu W, Lindsey M, Irsheid S, Nebbitt V. Psychometric properties of the center for epidemiological studies-depression Scale (CES-D) among Black adolescents. Journal of the Society for Social Work and Research. 2017.
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Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools
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