DepressionNCT03940508
Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools
A study testing Making Connections Intervention and IPT-A in people with Depression and Suicidal Ideation, run by New York University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Suicidal Ideation
- What is being tested?
- Making Connections Intervention and IPT-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10003
McSilver Institute for Poverty Policy and Research
New York, New York, 10003
About this study
Official title: Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study
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.
Read the 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.
- Conditions
- Depression, Suicidal Ideation
- Being tested
- Making Connections Intervention, IPT-A
- Keywords
- depression, treatment engagement, adolescents, Black youth, Intervention
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Connections InterventionBehavioural
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-ABehavioural
Also called Interpersonal Psychotherapy for Depressed Adolescents
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
| Study group | Role | What they receive |
|---|---|---|
| MCI + IPT-A | Experimental | Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression. Receives: Behavioral: Making Connections Intervention; Behavioral: IPT-A |
| IPT-A Only | Active comparator | Participants will receive IPT-A for depression. Receives: Behavioral: IPT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Demographic Form
To measure participants' demographic characteristics
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start31 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Lindsey, PhD, Principal investigator, NYU Silver School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940508
- Sponsor's protocol ID
- 1R34MH119290-01
- Other IDs
- 1R34MH119290-01
- Status last verified
- Sep 2023
- First submitted
- 29 Apr 2019
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Submit data in compliance with NIMH Data Archive data submission agreement.
Publications
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.
PubMed 20350036Mufson 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.
PubMed 8056733Mufson 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.
PubMed 15648279Lindsey 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.
PubMed 23355768Lindsey 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.
PubMed 20953336Breland-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.
PubMed 21512751Lindsey 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.
PubMed 16512510Lindsey 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.
PubMed 28691838Ellis 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.
PubMed 23420474Lindsey 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.
PubMed 38336803
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study
- ClinicalTrials.gov ID
- NCT03940508
- Acronym / sponsor ID
- 1R34MH119290-01
- Conditions
- Depression, Suicidal Ideation
- Keywords
- depression, treatment engagement, adolescents, Black youth, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Columbia University
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI + IPT-A | Experimental | Behavioral: Making Connections Intervention, Behavioral: IPT-AParticipants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression. |
| IPT-A Only | Active comparator | Behavioral: IPT-AParticipants will receive IPT-A for depression. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Making Connections InterventionThe 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. | Behavioural | MCI + IPT-A |
| IPT-AAlso: Interpersonal Psychotherapy for Depressed AdolescentsIPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions. | Behavioural | IPT-A Only, MCI + IPT-A |
Primary outcome
Center for Epidemiological Studies-Depression Scale
Time frame: Baseline
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.
Hamilton Rating Scale for Depression
Time frame: Baseline
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.
Demographic Form
Time frame: Baseline
To measure participants' demographic characteristics
Columbia-Suicide Severity Rating Scale
Time frame: Baseline
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.
Barriers for Adolescents Seeking Health
Time frame: Baseline
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.
Child Help-Seeking Scale
Time frame: Baseline
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.
Attitudes Toward Psychological Help Scale
Time frame: Baseline
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.
Stages of Change
Time frame: Baseline
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.
Barriers to Treatment Participation Scale
Time frame: Baseline
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).
Understanding Mood Disorders Questionnaire
Time frame: Baseline
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.
Therapy Survey
Time frame: Baseline
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.
Suicidal Ideation Questionnaire-Junior
Time frame: Baseline
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.
Global Assessment Scale for Children
Time frame: Baseline
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.
Interpersonal Needs
Time frame: Baseline
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.
Penn Helping Alliance Revised
Time frame: Week 4
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20350036Gunlicks-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.
- Background: PubMed 8056733Mufson 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.
- Background: PubMed 15648279Mufson 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.
- Background: PubMed 23355768Lindsey 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.
- Background: PubMed 20953336Lindsey 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.
- Background: PubMed 21512751Breland-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.
- Background: PubMed 16512510Lindsey 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.
- Background: PubMed 28691838Lindsey 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.
- Background: PubMed 23420474Ellis 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.
- Derived from this study: PubMed 38336803Lindsey 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Submit data in compliance with NIMH Data Archive data submission agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Lindsey, PhD principal investigator
NYU Silver School of Social Work
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making Connections Intervention and IPT-A in people with Depression and Suicidal Ideation, run by New York University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiological Studies-Depression Scale (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940508, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.