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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH119290-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Columbia University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCI + IPT-A | Experimental | Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression. |
|
| IPT-A Only | Active Comparator | Participants will receive IPT-A for depression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Making Connections Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiological Studies-Depression Scale | A 20-item self-report scale designed to measure depressive symptomatology in the general population. Scores range from 0 to 60, with higher scores indicating greater depression symptoms. 16 is a common clinical cutoff. | Baseline |
| Hamilton Rating Scale for Depression | Determines a patient's level of depression before, during, and after treatment. Scores range from 0 to 52, with higher scores indicating greater severity of depression. Scores of 0-7 indicate no depression. | Baseline |
| Demographic Form | To measure participants' demographic characteristics | Baseline |
| Columbia-Suicide Severity Rating Scale | 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. "Yes" and "No" categories are used to determine suicide risk, with binary coding where No=0 and Yes=1 for items 1-5. The higher number indicating more intense ideation. Total scores of items 1-5 were analyzed, with the lowest score =0 and the highest score=5. | Baseline |
| Barriers for Adolescents Seeking Health | Self-report questionnaire that targets barriers to seeking professional psychological help. Scores range from 37 to 111, with higher scores indicating greater barriers to help seeking behaviors. | Baseline |
| Child Help-Seeking Scale | 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. Scores for part one range from 16 to 64 and scores for part two rang from 7 to 28, with higher scores indicating less help- seeking. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Lindsey, PhD | NYU Silver School of Social Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10003 | United States | ||
| McSilver Institute for Poverty Policy and Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20350036 | Background | 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. | |
| 8056733 | Background | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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Submit data in compliance with NIMH Data Archive data submission agreement.
By the end of data collection, December 2023.
In accordance with the NIMH Data Archive requirements.
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| ID | Title | Description |
|---|---|---|
| FG000 | MCI + IPT-A | Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression. 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. |
| FG001 | IPT-A Only | Participants will receive IPT-A for depression. IPT-A: IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MCI + IPT-A | Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Center for Epidemiological Studies-Depression Scale | A 20-item self-report scale designed to measure depressive symptomatology in the general population. Scores range from 0 to 60, with higher scores indicating greater depression symptoms. 16 is a common clinical cutoff. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
Baseline
Any untoward medical occurrence associated in humans, whether or not considered treatment related.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MCI + IPT-A | Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression. 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. No participants in our small sample experienced SAEs or AEs in either condition. |
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Our recruitment was negatively impacted by COVID-19 and the closure of NYC Schools during the time of the study. While the study team pivoted to virtual recruitment and implementation, our inability to be onsite drastically reduced our ability to build rapport and recruit participants, yielding only 2 participants who completed IPT-A only and 9 who completed MCI+IPT-A. Baseline descriptives are reported only; the small sample size restricted our ability to compare groups on the outcome data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael A. Lindsey | New York University | 212-998-5959 | michael.lindsey@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2019 | May 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2021 | Jul 2, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D000079062 | Interpersonal Psychotherapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| IPT-A | Behavioral | IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions. |
|
|
| Baseline |
| Attitudes Toward Psychological Help Scale | 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. Scores range from 0-15, with higher scores indicating greater stigma. | Baseline |
| Stages of Change | 32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy. The highest score among each sub-scale indicates which stage of change a person is in. Thus, sub-scale scores are reported. Sub-scale scores do not indicate a better or worse outcome; instead, higher scores indicate a readiness to take action to address mental health concerns on each sub-scale. Pre-contemplation scores range from 5-20, Contemplation scores range from 4-16, Action scores range from 5-20, and Maintenance scores range from 4-16. | Baseline |
| Barriers to Treatment Participation Scale | 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. Higher scores indicating greater barriers to treatment. Sub-scale scores range from 20 to 100 (Stressors), 10-50 (Demands), and 8-40 (Perceived Relevance of Treatment). | Baseline |
| Understanding Mood Disorders Questionnaire | Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders. Scores range from 9 to 40, with higher scores indicating less understanding of how depression presents and functions. | Baseline |
| Therapy Survey | To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions. Scores range from 7 to 35, with higher scores indicating misconceptions about the role of therapy. | Baseline |
| Suicidal Ideation Questionnaire-Junior | 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. Scores range from 0 to 90, with a typical clinical cutoff score of 31 indicating further evaluation due to increased risk of suicidal ideation. | Baseline |
| Global Assessment Scale for Children | 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. Higher scores indicate higher functioning, ranging from 1-100. | Baseline |
| Interpersonal Needs | A 15-item questionnaire to measure changes in students' social connectedness and social competence. Total scores ranging from 15-99 are reported with higher scores indicated less social connectedness. | Baseline |
| Penn Helping Alliance Revised | 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. Scores range from 6 to 36, with a higher score indicating greater therapeutic alliance. | Week 4 |
| New York |
| New York |
| 10003 |
| United States |
| 15648279 | Background | 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. |
| 23355768 | Background | 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. |
| 20953336 | Background | 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. |
| 21512751 | Background | 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. |
| 16512510 | Background | 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. |
| 28691838 | Background | 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. |
| 23420474 | Background | 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. |
| 38336803 | Derived | Lindsey MA, Mufson L, Velez-Grau C, Grogan T, Wilson DM, Reliford AO, Gunlicks-Stoessel M, Jaccard J. Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot. Trials. 2024 Feb 9;25(1):112. doi: 10.1186/s13063-024-07947-8. |
| BG001 | IPT-A Only | Participants will receive IPT-A for depression. IPT-A: IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | IPT-A Only | Participants will receive IPT-A for depression. IPT-A: IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions. |
|
|
| Primary | Hamilton Rating Scale for Depression | Determines a patient's level of depression before, during, and after treatment. Scores range from 0 to 52, with higher scores indicating greater severity of depression. Scores of 0-7 indicate no depression. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Demographic Form | To measure participants' demographic characteristics | Posted | Number | participants | Baseline |
|
|
|
| Primary | Columbia-Suicide Severity Rating Scale | 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. "Yes" and "No" categories are used to determine suicide risk, with binary coding where No=0 and Yes=1 for items 1-5. The higher number indicating more intense ideation. Total scores of items 1-5 were analyzed, with the lowest score =0 and the highest score=5. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Barriers for Adolescents Seeking Health | Self-report questionnaire that targets barriers to seeking professional psychological help. Scores range from 37 to 111, with higher scores indicating greater barriers to help seeking behaviors. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Child Help-Seeking Scale | 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. Scores for part one range from 16 to 64 and scores for part two rang from 7 to 28, with higher scores indicating less help- seeking. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Attitudes Toward Psychological Help Scale | 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. Scores range from 0-15, with higher scores indicating greater stigma. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Stages of Change | 32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy. The highest score among each sub-scale indicates which stage of change a person is in. Thus, sub-scale scores are reported. Sub-scale scores do not indicate a better or worse outcome; instead, higher scores indicate a readiness to take action to address mental health concerns on each sub-scale. Pre-contemplation scores range from 5-20, Contemplation scores range from 4-16, Action scores range from 5-20, and Maintenance scores range from 4-16. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Barriers to Treatment Participation Scale | 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. Higher scores indicating greater barriers to treatment. Sub-scale scores range from 20 to 100 (Stressors), 10-50 (Demands), and 8-40 (Perceived Relevance of Treatment). | Caregiver measure | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Understanding Mood Disorders Questionnaire | Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders. Scores range from 9 to 40, with higher scores indicating less understanding of how depression presents and functions. | Caregiver measure | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Therapy Survey | To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions. Scores range from 7 to 35, with higher scores indicating misconceptions about the role of therapy. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Suicidal Ideation Questionnaire-Junior | 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. Scores range from 0 to 90, with a typical clinical cutoff score of 31 indicating further evaluation due to increased risk of suicidal ideation. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Global Assessment Scale for Children | 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. Higher scores indicate higher functioning, ranging from 1-100. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Interpersonal Needs | A 15-item questionnaire to measure changes in students' social connectedness and social competence. Total scores ranging from 15-99 are reported with higher scores indicated less social connectedness. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Penn Helping Alliance Revised | 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. Scores range from 6 to 36, with a higher score indicating greater therapeutic alliance. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | IPT-A Only | Participants will receive IPT-A for depression. IPT-A: IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions. No participants in our small sample experienced SAEs or AEs in either condition. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Sex-Female |
|
| Sex-Male |
|
| Disability-Yes |
|
| Special Education-Yes |
|
| Ever treatment for emotional or behavioral difficulties?-Yes |
|
| Action |
|
| Maintenance |
|
| Subscale 2 (Treatment Demands) |
|
| Subscale 3 (Perceived Relevance of Treatment) |
|