Trial Outcomes & Findings for Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder (NCT NCT00338806)

NCT ID: NCT00338806

Last Updated: 2017-08-15

Results Overview

A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-08-15

Participant Flow

Recruitment dates:10/06-5/10 Location: New York State Psychiatric Institute (mental health research and patient care)

Enrolled subjects were excluded from the trial because they were found to be either too symptomatic or asymptomatic

Participant milestones

Measure	Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Acute Phase STARTED	2	5
Acute Phase COMPLETED	2	4
Acute Phase NOT COMPLETED	0	1
Follow-up STARTED	2	4
Follow-up COMPLETED	1	1
Follow-up NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Acute Phase Withdrawal by Subject	0	1
Follow-up Lost to Follow-up	1	3

Baseline Characteristics

Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder

Baseline characteristics by cohort

Measure	IPT- Prevention for Adolescents n=2 Participants Participants will receive interpersonal psychotherapy for prevention with adolescents Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Educational and Clinical Monitoring n=5 Participants Participants will receive educational clinical monitoring Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	7 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	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

A semi-structured interview designed to assess present episode of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
K SADS-Present Version (KSADS-P) Participants with sub-syndromal depression	0 participants	2 participants
K SADS-Present Version (KSADS-P) Participants with sub-syndromal mania	1 participants	0 participants
K SADS-Present Version (KSADS-P) Participants with current Oppositional defiant dis	1 participants	1 participants
K SADS-Present Version (KSADS-P) Participants with current Depression	0 participants	1 participants
K SADS-Present Version (KSADS-P) Participants with current Specific phobia	1 participants	0 participants
K SADS-Present Version (KSADS-P) Participants with current subsyndromal PTSD	0 participants	1 participants

PRIMARY outcome

Timeframe: 6 months

A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=2 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
K SADS-Present Version (KSADS-P) Participants with sub-syndromal depression	0 participants	1 participants
K SADS-Present Version (KSADS-P) Participants with Specific phobia	1 participants	0 participants
K SADS-Present Version (KSADS-P) Participant with major depression	0 participants	1 participants

PRIMARY outcome

Timeframe: 12 months

Population: At the 12 month follow up timepoint only 1 participant was available and willing to be assessed.

A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=1 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
K SADS-Present Version (KSADS-P) Participants with sub-syndromal depression	—	1 participants
K SADS-Present Version (KSADS-P) Participants with sub-syndromal mania	—	1 participants

PRIMARY outcome

Timeframe: 18 months

Population: At the 18 month follow up point only 1 participant was available and willing be assessed.

A semi-structured interview designed to assess present episode and episode since last assessment of psychiatric illness according to DSM-IV criteria. The mood, anxiety, substance use and disruptive disorders sections were administered.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
K SADS-Present Version (KSADS-P) Participants with sub-syndromal depression	0 participants	—
K SADS-Present Version (KSADS-P) Participant with specific phobia	1 participants	—

PRIMARY outcome

Timeframe: Week 12

CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Depression Rating Scale-Revised (CDRS-R)	26.50 units on a scale Standard Deviation 7.78	28.75 units on a scale Standard Deviation 7.85

PRIMARY outcome

Timeframe: 6 months

CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=2 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Depression Rating Scale-Revised (CDRS-R)	26 units on a scale Standard Deviation 0	29.5 units on a scale Standard Deviation 2.12

PRIMARY outcome

Timeframe: 12 months

Population: At the 12 month time point 1 participant was available /willing to be assessed

CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=1 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Depression Rating Scale-Revised (CDRS-R)	—	31 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 18 months

Population: At the 18 month time point 1 participant was available /willing to be assessed

CDRS-R Total score measures the presence and severity of depression in children/adolescents. The scale has 17 items scored on a 1-to-5 (3 items)- or 1-to-7 (14 items)-point scale. Total scores range from 17 to 113. Lower scores indicate lower depression, scores > 41 indicate mild-moderate depression.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Depression Rating Scale-Revised (CDRS-R)	25 units on a scale Standard Deviation 0	—

PRIMARY outcome

Timeframe: Week 12

C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Global Assessment Scale (C-GAS)	76 units on a scale Standard Deviation 1.41	70 units on a scale Standard Deviation 4.16

PRIMARY outcome

Timeframe: 6 months

C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=2 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Global Assessment Scale (C-GAS)	81 units on a scale Standard Deviation 0	77.5 units on a scale Standard Deviation 3.54

PRIMARY outcome

Timeframe: 12 months

Population: At the 12 month time point 1 participant was available /willing to be assessed

C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=1 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Global Assessment Scale (C-GAS)	—	79 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 18 months

Population: At the 18 month time point 1 participant was available /willing to be assessed

C-GAS is a clinician-rated measure of overall severity of disturbance. A single assigned score ranging from 0 (most severe level of impairment) to 100 (absence of impairment) represents level of functional impairment.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Children's Global Assessment Scale (C-GAS)	79 units on a scale Standard Deviation 0	—

PRIMARY outcome

Timeframe: Week 12

An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Young Mania Rating Scale (YMRS)	7 units on a scale Standard Deviation 8.49	4.5 units on a scale Standard Deviation 4.04

PRIMARY outcome

Timeframe: 6 months

An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=2 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Young Mania Rating Scale (YMRS)	2 units on a scale Standard Deviation 0	3.5 units on a scale Standard Deviation 0.71

PRIMARY outcome

Timeframe: 12 months

Population: At the 12 month time point 1 participant was available /willing to be assessed

An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=1 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Young Mania Rating Scale (YMRS)	—	6 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 18 months

Population: At the 18 month time point 1 participant was available /willing to be assessed

An 11-item clinician-rated instrument for assessing the severity of manic episodes. 7 of the items are rated on a scale 0-4 and 4 are rated from 0-8. Total scores can range from 0-60, with higher scores indicating greater severity of symptoms.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Young Mania Rating Scale (YMRS)	3 units on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: Measured at Week 12

A 4 item measure to evaluate attitudes towards: length of treatment, helpfulness of therapist, effects of participating in research, and additional services desired. Each item had 3 response options: 1.positive (or longer treatment) 2.neutral (or length just right) 3. negative (or shorter treatment). Scores are summed with potential range from 4-12. Lower number indicates more positive attitude

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Attitudes Toward Treatment Questionnaire	6.50 units on a scale Standard Deviation 2.12	7.20 units on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Measured at Week 12

Population: Data were not collected for 6 and 12 month time points

A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).

Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Emotion Regulation Questionnaire Cognitive reappraisal	4.5 units on a scale Standard Deviation 0.42	4.02 units on a scale Standard Deviation 0.91
Emotion Regulation Questionnaire Emotional suppression	3.35 units on a scale Standard Deviation 0.64	4.62 units on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: 6 months

A self-report10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).

Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=1 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=2 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Emotion Regulation Questionnaire Cognitive reappraisal	4 units on a scale Standard Deviation 0	3.5 units on a scale Standard Deviation 0.71
Emotion Regulation Questionnaire Emotional suppression	3 units on a scale Standard Deviation 0	4.5 units on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 12 months and 18 months

Population: At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)

A self report 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet (score is averaged, i.e., the score lies between 1 and 7), higher score indicates higher Cognitive reappraisal).

Items 2, 4, 6, 9 make up the Expressive Suppression facet (score is averaged, i.e., the score lies between 1 and 7, higher score indicates higher Expressive Suppression).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Week 12

The General Functioning scale, that assesses the overall health/pathology of the family, is used for the study. The 12 item scores are averaged to calculate the total score, which ranges from 1-4, with higher scores reflecting worse functioning

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Family Assessment Device	2.3 units on a scale Standard Deviation 0.85	2.7 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Measured at Week 1 (baseline)

A clinician-administered instrument to the adolescent' parent, designed to screen for mood, anxiety, and other disorders in parent's first-degree relatives (parents, spouse).

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Family History Screen Participants w/ parent'srelatives w/mood disorde	2 participants	4 participants
Family History Screen Participants w/ parent's relatives w/ anxiety	2 participants	3 participants
Family History Screen Participants w/ parents relatives w/substance use	1 participants	2 participants

SECONDARY outcome

Timeframe: Week 1

Population: This measure reflects parental mood.expressed as number of participants whose parent with BDI or BDII endorsed \> 7(1)

A self-report inventory for the participant' parent that screens for history of a manic or hypomanic syndrome by including 13 yes/no items. A score >7 indicate possible history of mania/hypomania (coded as 1), <7 indicates potential absence of mania/hypomania (coded as 0)

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Mood Disorder Questionnaire	2 participants	4 participants

SECONDARY outcome

Timeframe: Measured at Week 1

The PHQ-9 is a depression screen, administered to the adolescents parents in this study. The PHQ-9 scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Scores can range from 0-27, with higher score indicating higher depression levels.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Patient Health Questionnaire	12 units on a scale Standard Deviation 2.8	14.5 units on a scale Standard Deviation 3.70

SECONDARY outcome

Timeframe: Measured at Week 12

(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=4 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Social Adjustment Scale - Self Report for Adolescents	1.9 units on a scale Standard Deviation 0.42	2.5 units on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: 12 months and 18 months

Population: At the 12 and 18 months time point no participant was willing to be assessed on this secondary outcome measure (had limited time for these assessment visits)

(SAS-SR) for adolescents, a self-report instrument with 23 questions that fall into 4 major categories: school, friends, family, and dating. Patients rate themselves for the past 2 weeks and they can receive either a total score or a domain specific score. The total score is used here. Each item is scored 1-5, the total score is the average of the scores on each item, possible range of scores 1-5, higher scores indicating worse functioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Week 12 and Months 6, 12, and 18 post-treatment

Population: Participants were not filling out form (it required documentation during the week) and reconstructing it in the meetings with the clinician proved to be too time consuming. Measure was withdrawn from the assessment battery

The Social Rhythm Metric Short Form (SRM-Short Form) measures habitual time at which 5 daily events occur in a person's life over a one-week interval: what time the adolescent gets out of bed, makes first contact with another person, starts school, has dinner, and goes to bed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Week 1

Population: An ECM participant did not fill out her form

Treatment Credibility Questionnaire. Participant and parent's expectancy about the perceived benefit of treatment will be assessed following the first intervention session after the treatment rationale is given. Adolescents were asked to rate how logical the treatment seemed to them, how confident they were that it would be successful, and how confident they would be in recommending the treatment to a friend. A 0- to 2-point rating scale (0 = none, 1 = some, 2 = a lot) was used (range of possible overall score 0-6, higher score indicating higher treatment credibility)

Outcome measures

Measure	Interpersonal Psychotherapy for Prevention n=2 Participants Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder	Educational Clinical Monitoring n=3 Participants Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
Treatment Credibility Scale	4 units on a scale Standard Deviation 1.41	3.75 units on a scale Standard Deviation 0.96

Adverse Events

Interpersonal Psychotherapy for Prevention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Educational Clinical Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Helen Verdeli

NYSPInstitute

Phone: 212 543 5262

Email: verdelih@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place