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

Depression Clinical Trial

Official title:

Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940508
• Other study ID #: 1R34MH119290-01
• Secondary ID: 1R34MH119290-01
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Suicidal Ideation
• Suicide
• Suicide Prevention

Intervention

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.
• IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	McSilver Institute for Poverty Policy and Research	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University	Columbia University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Barriers for Adolescents Seeking Health (BASH)	Self-report questionnaire that targets barriers to seeking professional psychological help	Baseline, week 1, weeks 4, 8, 12
Primary	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.	Baseline, week 1, weeks 4, 8, 12
Primary	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.	Baseline, week 1, weeks 4, 8, 12
Primary	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.	Baseline, week 1, weeks 4, 8, 12
Primary	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."	Baseline, week 1, weeks 4, 8, 12
Primary	MCI Integrity Scale (MCI)	To measure treatment integrity in Making Connections Intervention (MCI)	Week 1
Primary	Change in IPT-A Fidelity Form (IPT-A)	To measure treatment integrity in IPT-A and maintain treatment effectiveness	From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
Primary	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.	Baseline, week 1, weeks 4, 8, 12
Primary	Understanding Mood Disorders Questionnaire (UMDQ)	Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders	Baseline, week 1, weeks 4, 8, 12
Primary	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.	Baseline, week 1, weeks 4, 8, 12
Primary	Change in Progress of Treatment (POT)	To measure adolescent engagement in treatment in order to control for the common factors of psychotherapy.	From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
Primary	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)	Week 8 and Week 12
Primary	Change in Evidence-Based Practice Attitude Scale (EBPAS)	Assesses mental health service provider attitudes toward adopting evidence-based practices.	Week 1, week 12
Primary	Service use logs (SUL)	Measures the change in attendance of treatment session by therapists.	From the time of the first weekly therapy session until the course of IPT-A treatment is completed, approximately 12 weeks.
Primary	Termination form (TF)	Measures the termination of treatment session by therapists	Week 12
Primary	Change in Hamilton Rating Scale for Depression (HRSD)	Determines a patient's level of depression before, during, and after treatment.	Baseline, week 1, weeks 4, 8, 12
Primary	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.	Screen, baseline, weeks 4,8,12
Primary	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.	Baseline, weeks 4,8,12
Primary	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.	Baseline, weeks 4,8,12
Primary	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.	Baseline, weeks 4,8,12
Primary	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").	Week 1, week 12
Primary	Demographic Form (DF)	To measure participants' demographic characteristics	Baseline
Primary	School records (GL)	To measure youth's school records	Baseline
Primary	Change in School Performance- GPA, Number of Suspensions, and School attendance (SP)	To measure students' school performance, number of suspensions, and school attendance.	Baseline, weeks 4, 8, 12
Primary	Change in Interpersonal Needs (INQ)	A 15-item questionnaire to measure changes in students' social connectedness and social competence.	Baseline, weeks 4, 8, 12

External Links

•   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.