Trial Outcomes & Findings for Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools (NCT NCT03940508)
NCT ID: NCT03940508
Last Updated: 2025-09-15
Results Overview
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.
COMPLETED
NA
29 participants
Baseline
2025-09-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
10
|
|
Overall Study
COMPLETED
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools
Baseline characteristics by cohort
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
194.68 Months
STANDARD_DEVIATION 17.29 • n=5 Participants
|
193.80 Months
STANDARD_DEVIATION 11.51 • n=7 Participants
|
194.37 Months
STANDARD_DEVIATION 15.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineA 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Center for Epidemiological Studies-Depression Scale
|
36.84 units on a scale
Standard Deviation 11.85
|
40.90 units on a scale
Standard Deviation 11.60
|
PRIMARY outcome
Timeframe: BaselineDetermines 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Hamilton Rating Scale for Depression
|
14.47 units on a scale
Standard Deviation 8.66
|
16.60 units on a scale
Standard Deviation 7.33
|
PRIMARY outcome
Timeframe: BaselineTo measure participants' demographic characteristics
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Demographic Form
Born in NYC-Yes
|
17 participants
|
9 participants
|
|
Demographic Form
Born in NYC-No
|
2 participants
|
1 participants
|
|
Demographic Form
Sex-Female
|
13 participants
|
10 participants
|
|
Demographic Form
Sex-Male
|
6 participants
|
0 participants
|
|
Demographic Form
Disability-Yes
|
0 participants
|
1 participants
|
|
Demographic Form
Special Education-Yes
|
0 participants
|
1 participants
|
|
Demographic Form
Ever treatment for emotional or behavioral difficulties?-Yes
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: BaselineTo 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale
|
0.94 units on a scale
Standard Deviation 1.68
|
1.1 units on a scale
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: BaselineSelf-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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Barriers for Adolescents Seeking Health
|
62.52 units on a scale
Standard Deviation 4.56
|
66.5 units on a scale
Standard Deviation 5.42
|
PRIMARY outcome
Timeframe: BaselineSelf-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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Child Help-Seeking Scale
HSS Part 1
|
38.68 units on a scale
Standard Deviation 3.62
|
39.6 units on a scale
Standard Deviation 2.67
|
|
Child Help-Seeking Scale
HSS Part 2
|
16.78 units on a scale
Standard Deviation 5.22
|
16.44 units on a scale
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: BaselineThis 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Attitudes Toward Psychological Help Scale
|
6.21 units on a scale
Standard Deviation 3.04
|
6.8 units on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Baseline32-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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Stages of Change
Maintenance
|
12.42 units on a scale
Standard Deviation 2.34
|
12.4 units on a scale
Standard Deviation 1.07
|
|
Stages of Change
Pre-contemplation
|
9.78 units on a scale
Standard Deviation 1.87
|
9.8 units on a scale
Standard Deviation 2.52
|
|
Stages of Change
Contemplation
|
13.05 units on a scale
Standard Deviation 1.39
|
13.5 units on a scale
Standard Deviation 1.43
|
|
Stages of Change
Action
|
15.26 units on a scale
Standard Deviation 2.02
|
14.5 units on a scale
Standard Deviation 3.27
|
PRIMARY outcome
Timeframe: BaselinePopulation: Caregiver measure
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).
Outcome measures
| Measure |
MCI + IPT-A
n=15 Participants
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.
|
IPT-A Only
n=7 Participants
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.
|
|---|---|---|
|
Barriers to Treatment Participation Scale
Subscale 2 (Treatment Demands)
|
16.46 units on a scale
Standard Deviation 7.20
|
13.42 units on a scale
Standard Deviation 5.59
|
|
Barriers to Treatment Participation Scale
Total
|
64.6 units on a scale
Standard Deviation 25.85
|
54.14 units on a scale
Standard Deviation 15.29
|
|
Barriers to Treatment Participation Scale
Subscale 1 (Stressors)
|
35.06 units on a scale
Standard Deviation 14.52
|
27.28 units on a scale
Standard Deviation 7.06
|
|
Barriers to Treatment Participation Scale
Subscale 3 (Perceived Relevance of Treatment)
|
13.06 units on a scale
Standard Deviation 5.73
|
13.42 units on a scale
Standard Deviation 4.27
|
PRIMARY outcome
Timeframe: BaselinePopulation: Caregiver measure
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.
Outcome measures
| Measure |
MCI + IPT-A
n=15 Participants
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.
|
IPT-A Only
n=7 Participants
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.
|
|---|---|---|
|
Understanding Mood Disorders Questionnaire
|
18.73 units on a scale
Standard Deviation 5.16
|
17 units on a scale
Standard Deviation 3.65
|
PRIMARY outcome
Timeframe: BaselineTo 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Therapy Survey
|
14.8 units on a scale
Standard Deviation 4.95
|
12.14 units on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: BaselineA 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Suicidal Ideation Questionnaire-Junior
|
25.68 units on a scale
Standard Deviation 17.01
|
29.3 units on a scale
Standard Deviation 19.05
|
PRIMARY outcome
Timeframe: BaselineTo 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Global Assessment Scale for Children
|
57.84 units on a scale
Standard Deviation 6.3
|
53.7 units on a scale
Standard Deviation 7.42
|
PRIMARY outcome
Timeframe: BaselineA 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.
Outcome measures
| Measure |
MCI + IPT-A
n=19 Participants
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.
|
IPT-A Only
n=10 Participants
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.
|
|---|---|---|
|
Interpersonal Needs
|
51.26 units on a scale
Standard Deviation 13.55
|
61.5 units on a scale
Standard Deviation 15.09
|
PRIMARY outcome
Timeframe: Week 4This 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.
Outcome measures
| Measure |
MCI + IPT-A
n=8 Participants
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.
|
IPT-A Only
n=5 Participants
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.
|
|---|---|---|
|
Penn Helping Alliance Revised
|
30.87 units on a scale
Standard Deviation 3.76
|
29.2 units on a scale
Standard Deviation 5.63
|
Adverse Events
MCI + IPT-A
IPT-A Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place