Depression, Suicidal Ideation
Conditions
Keywords
depression, treatment engagement, adolescents, Black youth, Intervention
Brief summary
Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the real world must be addressed. The investigators will examine the effectiveness of the Making Connections Intervention (MCI) and investigate key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products. This study will address an important public health issue: How best to connect Black adolescents with depression to treatment in clinically meaningful ways, and how best to deliver evidence-based treatment to them through school-based services.
Detailed description
Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. Their rates of participation in treatments for depression are lower due to negative perceptions of services and providers, and their reluctance to acknowledge the presence of symptoms. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the real world must be addressed. This research examines the effectiveness of the Making Connections Intervention (MCI) and investigates key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products. The investigators previously performed a small pilot study that used the MCI as an add-on to the IPT-A, an evidence-based intervention for depression delivered in schools typically over 12 sessions. The results suggested that MCI has a positive impact on many aspects of change associated with treatment engagement and clinical outcomes. This study will be a randomized controlled trial. It will examine the effectiveness of the MCI in a multi-school trial involving adolescents in grades 6-12 who attend New York City (NYC) Department of Education (DOE) Public Schools. The investigators will randomly assign 60 Black students with depression symptoms to two conditions: MCI+IPT-A vs. IPT-A-alone. The investigators will also do qualitative research, like interviews, before the digital content is created. This will enhance the relevance of the MCI. The main outcomes are adolescent-and caregiver-level engagement and adolescent depression. Suicidal ideation is a secondary outcome. This study will also test related factors, like adolescent helping-seeking behavior and parental knowledge of mental health services, that can account for treatment outcomes and that will allow the MCI to be strengthened in future roll-outs of the intervention in school settings.
Interventions
BEHAVIORALMaking 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.
BEHAVIORALIPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Sponsors
National Institute of Mental Health (NIMH)
Columbia University
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiological Studies-Depression Scale | 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 | 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 | Baseline | To measure participants' demographic characteristics |
| Columbia-Suicide Severity Rating Scale | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 10 |
| Total | 29 |
Baseline characteristics
| Characteristic | IPT-A Only | Total | MCI + IPT-A |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 27 Participants | 17 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 193.80 Months STANDARD_DEVIATION 11.51 | 194.37 Months STANDARD_DEVIATION 15.32 | 194.68 Months STANDARD_DEVIATION 17.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 29 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 Participants | 29 Participants | 19 Participants |
| Sex: Female, Male Female | 10 Participants | 23 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 10 |
| other Total, other adverse events | 0 / 19 | 0 / 10 |
| serious Total, serious adverse events | 0 / 19 | 0 / 10 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Attitudes Toward Psychological Help Scale | 6.21 units on a scale | Standard Deviation 3.04 |
| IPT-A Only | Attitudes Toward Psychological Help Scale | 6.8 units on a scale | Standard Deviation 2.14 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Barriers for Adolescents Seeking Health | 62.52 units on a scale | Standard Deviation 4.56 |
| IPT-A Only | Barriers for Adolescents Seeking Health | 66.5 units on a scale | Standard Deviation 5.42 |
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).
Time frame: Baseline
Population: Caregiver measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MCI + IPT-A | Barriers to Treatment Participation Scale | Total | 64.6 units on a scale | Standard Deviation 25.85 |
| MCI + IPT-A | Barriers to Treatment Participation Scale | Subscale 1 (Stressors) | 35.06 units on a scale | Standard Deviation 14.52 |
| MCI + IPT-A | Barriers to Treatment Participation Scale | Subscale 2 (Treatment Demands) | 16.46 units on a scale | Standard Deviation 7.2 |
| MCI + IPT-A | Barriers to Treatment Participation Scale | Subscale 3 (Perceived Relevance of Treatment) | 13.06 units on a scale | Standard Deviation 5.73 |
| IPT-A Only | Barriers to Treatment Participation Scale | Subscale 3 (Perceived Relevance of Treatment) | 13.42 units on a scale | Standard Deviation 4.27 |
| IPT-A Only | Barriers to Treatment Participation Scale | Total | 54.14 units on a scale | Standard Deviation 15.29 |
| IPT-A Only | Barriers to Treatment Participation Scale | Subscale 2 (Treatment Demands) | 13.42 units on a scale | Standard Deviation 5.59 |
| IPT-A Only | Barriers to Treatment Participation Scale | Subscale 1 (Stressors) | 27.28 units on a scale | Standard Deviation 7.06 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Center for Epidemiological Studies-Depression Scale | 36.84 units on a scale | Standard Deviation 11.85 |
| IPT-A Only | Center for Epidemiological Studies-Depression Scale | 40.90 units on a scale | Standard Deviation 11.6 |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MCI + IPT-A | Child Help-Seeking Scale | HSS Part 1 | 38.68 units on a scale | Standard Deviation 3.62 |
| MCI + IPT-A | Child Help-Seeking Scale | HSS Part 2 | 16.78 units on a scale | Standard Deviation 5.22 |
| IPT-A Only | Child Help-Seeking Scale | HSS Part 1 | 39.6 units on a scale | Standard Deviation 2.67 |
| IPT-A Only | Child Help-Seeking Scale | HSS Part 2 | 16.44 units on a scale | Standard Deviation 4.8 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Columbia-Suicide Severity Rating Scale | 0.94 units on a scale | Standard Deviation 1.68 |
| IPT-A Only | Columbia-Suicide Severity Rating Scale | 1.1 units on a scale | Standard Deviation 2.13 |
Primary
Demographic Form
To measure participants' demographic characteristics
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCI + IPT-A | Demographic Form | Sex-Female | 13 participants |
| MCI + IPT-A | Demographic Form | Disability-Yes | 0 participants |
| MCI + IPT-A | Demographic Form | Born in NYC-No | 2 participants |
| MCI + IPT-A | Demographic Form | Special Education-Yes | 0 participants |
| MCI + IPT-A | Demographic Form | Sex-Male | 6 participants |
| MCI + IPT-A | Demographic Form | Ever treatment for emotional or behavioral difficulties?-Yes | 3 participants |
| MCI + IPT-A | Demographic Form | Born in NYC-Yes | 17 participants |
| IPT-A Only | Demographic Form | Ever treatment for emotional or behavioral difficulties?-Yes | 1 participants |
| IPT-A Only | Demographic Form | Born in NYC-Yes | 9 participants |
| IPT-A Only | Demographic Form | Born in NYC-No | 1 participants |
| IPT-A Only | Demographic Form | Sex-Female | 10 participants |
| IPT-A Only | Demographic Form | Sex-Male | 0 participants |
| IPT-A Only | Demographic Form | Disability-Yes | 1 participants |
| IPT-A Only | Demographic Form | Special Education-Yes | 1 participants |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Global Assessment Scale for Children | 57.84 units on a scale | Standard Deviation 6.3 |
| IPT-A Only | Global Assessment Scale for Children | 53.7 units on a scale | Standard Deviation 7.42 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Hamilton Rating Scale for Depression | 14.47 units on a scale | Standard Deviation 8.66 |
| IPT-A Only | Hamilton Rating Scale for Depression | 16.60 units on a scale | Standard Deviation 7.33 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Interpersonal Needs | 51.26 units on a scale | Standard Deviation 13.55 |
| IPT-A Only | Interpersonal Needs | 61.5 units on a scale | Standard Deviation 15.09 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Penn Helping Alliance Revised | 30.87 units on a scale | Standard Deviation 3.76 |
| IPT-A Only | Penn Helping Alliance Revised | 29.2 units on a scale | Standard Deviation 5.63 |
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MCI + IPT-A | Stages of Change | Pre-contemplation | 9.78 units on a scale | Standard Deviation 1.87 |
| MCI + IPT-A | Stages of Change | Contemplation | 13.05 units on a scale | Standard Deviation 1.39 |
| MCI + IPT-A | Stages of Change | Action | 15.26 units on a scale | Standard Deviation 2.02 |
| MCI + IPT-A | Stages of Change | Maintenance | 12.42 units on a scale | Standard Deviation 2.34 |
| IPT-A Only | Stages of Change | Maintenance | 12.4 units on a scale | Standard Deviation 1.07 |
| IPT-A Only | Stages of Change | Pre-contemplation | 9.8 units on a scale | Standard Deviation 2.52 |
| IPT-A Only | Stages of Change | Action | 14.5 units on a scale | Standard Deviation 3.27 |
| IPT-A Only | Stages of Change | Contemplation | 13.5 units on a scale | Standard Deviation 1.43 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Suicidal Ideation Questionnaire-Junior | 25.68 units on a scale | Standard Deviation 17.01 |
| IPT-A Only | Suicidal Ideation Questionnaire-Junior | 29.3 units on a scale | Standard Deviation 19.05 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Therapy Survey | 14.8 units on a scale | Standard Deviation 4.95 |
| IPT-A Only | Therapy Survey | 12.14 units on a scale | Standard Deviation 3.8 |
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.
Time frame: Baseline
Population: Caregiver measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI + IPT-A | Understanding Mood Disorders Questionnaire | 18.73 units on a scale | Standard Deviation 5.16 |
| IPT-A Only | Understanding Mood Disorders Questionnaire | 17 units on a scale | Standard Deviation 3.65 |