Bipolar Disorder, Depression
Conditions
Keywords
Prevention, Mood Disorders, Unipolar Depression
Brief summary
This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.
Detailed description
Bipolar Disorder (BD) is a serious medical illness that causes drastic shifts in a person's mood, energy, and ability to function. BD symptoms alternate from increased energy, restlessness, and overly good mood to a lasting sad, anxious, or empty mood and feelings of hopelessness or pessimism. Research suggests that children of parents with BD are at risk for developing mood disorders because of predisposing genetic factors and stressful life events, many of which may be related to their parents' unstable clinical state. Adolescent children of parents with BD must deal simultaneously with the difficult task of negotiating their own developmental transitions, as well as living with a parent with BD. It may be possible to detect symptoms of BD or other mood disorders early in adolescence and prevent the disorder from further interfering with someone's life. This study will develop and refine strategies for early detection and primary prevention of mood disorders and associated impairment in adolescent children of parents with BD. Participants in this single-blind study will be randomly assigned to receive either interpersonal psychotherapy with adolescents (IPT-PA) or a control intervention, educational clinical monitoring (ECM), for 12 weeks. Participants assigned to IPT-PA will attend twelve sessions. The first four sessions will last 90 minutes each, and will include both family psychoeducation and individual psychotherapy with the adolescent. The remaining sessions will be 45 minutes each, and will include only individual psychotherapy with the adolescent. Participants assigned to ECM will each be assigned to a therapist. During the initial two sessions, which will take place over 2 consecutive weeks, the therapist will focus on mood disorder psychoeducation and participants will receive related written educational material. Participants will then meet with their therapists monthly for 30-minute sessions. Symptoms and functioning will be assessed, but no assistance on building interpersonal skills will be provided. A participant may request a second session each month, but if more than two monthly sessions are required, the participant will be referred for therapy. Mood episodes and symptoms, symptom severity, and functioning will be assessed for all participants at Weeks 6 and 12 and Months 6, 12, and 18 post-treatment.
Interventions
BEHAVIORALInterpersonal psychotherapy for prevention with adolescents
Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.
BEHAVIORALEducational 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.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
for Parents: * Diagnosis of BD I or II * Currently in partial or full remission from a depressive or manic episode * Under active clinical care Inclusion Criteria for Adolescents: * Speaks English or Spanish * Presence of at least one current mood symptom meeting DSM-IV Criterion A and at least one depression or mania symptom meeting DSM-IV Criterion B * Depression, irritability, anhedonia, or elated mood scored at level 2 or 3 on the KSADS-PL * Mania symptom scored at level 2 or 3 on the KSADS-PL scale * Score of less than 40 on the CDRS-R scale * Score of less than 15 on the YMRS scale * Mild-moderate functional impairment, defined as a score of greater than 61 and less than 75 on the C-GAS scale
Exclusion criteria
for Parents: * History of psychosis within 1 month of study entry * At risk for suicide within 1 month of study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K SADS-Present Version (KSADS-P) | 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. |
| Children's Depression Rating Scale-Revised (CDRS-R) | 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. |
| Children's Global Assessment Scale (C-GAS) | 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. |
| Young Mania Rating Scale (YMRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood Disorder Questionnaire | Week 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) |
| Patient Health Questionnaire | 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. |
| Attitudes Toward Treatment Questionnaire | 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 |
| Social Rhythm Metric Short Form | Measured at Week 12 and Months 6, 12, and 18 post-treatment | 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. |
| Treatment Credibility Scale | Measured at Week 1 | 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) |
| Social Adjustment Scale - Self Report for Adolescents | 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. |
| Emotion Regulation Questionnaire | Measured at Week 12 | 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). |
| Family Assessment Device | 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 |
| Family History Screen | 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). |
Countries
United States
Participant flow
Recruitment details
Recruitment dates:10/06-5/10 Location: New York State Psychiatric Institute (mental health research and patient care)
Pre-assignment details
Enrolled subjects were excluded from the trial because they were found to be either too symptomatic or asymptomatic
Participants by arm
| Arm | Count |
|---|---|
| IPT- Prevention for Adolescents 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. | 2 |
| Educational and Clinical Monitoring 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. | 5 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Acute Phase | Withdrawal by Subject | 0 | 1 |
| Follow-up | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | IPT- Prevention for Adolescents | Educational and Clinical Monitoring | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| 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 | 0 Participants | 0 Participants | 0 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 | 2 Participants | 5 Participants | 7 Participants |
| Region of Enrollment United States | 2 participants | 5 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 5 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 |
Outcome results
Primary
Children's Depression Rating Scale-Revised (CDRS-R)
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Children's Depression Rating Scale-Revised (CDRS-R) | 26.50 units on a scale | Standard Deviation 7.78 |
| Educational Clinical Monitoring | Children's Depression Rating Scale-Revised (CDRS-R) | 28.75 units on a scale | Standard Deviation 7.85 |
Primary
Children's Depression Rating Scale-Revised (CDRS-R)
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.
Time frame: 18 months
Population: At the 18 month time point 1 participant was available /willing to be assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Children's Depression Rating Scale-Revised (CDRS-R) | 25 units on a scale | Standard Deviation 0 |
Primary
Children's Depression Rating Scale-Revised (CDRS-R)
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.
Time frame: 12 months
Population: At the 12 month time point 1 participant was available /willing to be assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Clinical Monitoring | Children's Depression Rating Scale-Revised (CDRS-R) | 31 units on a scale | Standard Deviation 0 |
Primary
Children's Depression Rating Scale-Revised (CDRS-R)
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Children's Depression Rating Scale-Revised (CDRS-R) | 26 units on a scale | Standard Deviation 0 |
| Educational Clinical Monitoring | Children's Depression Rating Scale-Revised (CDRS-R) | 29.5 units on a scale | Standard Deviation 2.12 |
Primary
Children's Global Assessment Scale (C-GAS)
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.
Time frame: 18 months
Population: At the 18 month time point 1 participant was available /willing to be assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Children's Global Assessment Scale (C-GAS) | 79 units on a scale | Standard Deviation 0 |
Primary
Children's Global Assessment Scale (C-GAS)
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Children's Global Assessment Scale (C-GAS) | 76 units on a scale | Standard Deviation 1.41 |
| Educational Clinical Monitoring | Children's Global Assessment Scale (C-GAS) | 70 units on a scale | Standard Deviation 4.16 |
Primary
Children's Global Assessment Scale (C-GAS)
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Children's Global Assessment Scale (C-GAS) | 81 units on a scale | Standard Deviation 0 |
| Educational Clinical Monitoring | Children's Global Assessment Scale (C-GAS) | 77.5 units on a scale | Standard Deviation 3.54 |
Primary
Children's Global Assessment Scale (C-GAS)
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.
Time frame: 12 months
Population: At the 12 month time point 1 participant was available /willing to be assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Clinical Monitoring | Children's Global Assessment Scale (C-GAS) | 79 units on a scale | Standard Deviation 0 |
Primary
K SADS-Present Version (KSADS-P)
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal depression | 0 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with Specific phobia | 1 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participant with major depression | 0 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal depression | 1 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with Specific phobia | 0 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participant with major depression | 1 participants |
Primary
K SADS-Present Version (KSADS-P)
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.
Time frame: 18 months
Population: At the 18 month follow up point only 1 participant was available and willing be assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal depression | 0 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participant with specific phobia | 1 participants |
Primary
K SADS-Present Version (KSADS-P)
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal mania | 1 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with current Depression | 0 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with current Specific phobia | 1 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal depression | 0 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with current subsyndromal PTSD | 0 participants |
| Interpersonal Psychotherapy for Prevention | K SADS-Present Version (KSADS-P) | Participants with current Oppositional defiant dis | 1 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with current subsyndromal PTSD | 1 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal depression | 2 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal mania | 0 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with current Oppositional defiant dis | 1 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with current Specific phobia | 0 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with current Depression | 1 participants |
Primary
K SADS-Present Version (KSADS-P)
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.
Time frame: 12 months
Population: At the 12 month follow up timepoint only 1 participant was available and willing to be assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal depression | 1 participants |
| Educational Clinical Monitoring | K SADS-Present Version (KSADS-P) | Participants with sub-syndromal mania | 1 participants |
Primary
Young Mania Rating Scale (YMRS)
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.
Time frame: 12 months
Population: At the 12 month time point 1 participant was available /willing to be assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Clinical Monitoring | Young Mania Rating Scale (YMRS) | 6 units on a scale | Standard Deviation 0 |
Primary
Young Mania Rating Scale (YMRS)
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Young Mania Rating Scale (YMRS) | 7 units on a scale | Standard Deviation 8.49 |
| Educational Clinical Monitoring | Young Mania Rating Scale (YMRS) | 4.5 units on a scale | Standard Deviation 4.04 |
Primary
Young Mania Rating Scale (YMRS)
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Young Mania Rating Scale (YMRS) | 2 units on a scale | Standard Deviation 0 |
| Educational Clinical Monitoring | Young Mania Rating Scale (YMRS) | 3.5 units on a scale | Standard Deviation 0.71 |
Primary
Young Mania Rating Scale (YMRS)
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.
Time frame: 18 months
Population: At the 18 month time point 1 participant was available /willing to be assessed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Young Mania Rating Scale (YMRS) | 3 units on a scale | Standard Deviation 0 |
Secondary
Attitudes Toward Treatment Questionnaire
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
Time frame: Measured at Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Attitudes Toward Treatment Questionnaire | 6.50 units on a scale | Standard Deviation 2.12 |
| Educational Clinical Monitoring | Attitudes Toward Treatment Questionnaire | 7.20 units on a scale | Standard Deviation 1.48 |
Secondary
Emotion Regulation Questionnaire
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).
Time frame: Measured at Week 12
Population: Data were not collected for 6 and 12 month time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Emotion Regulation Questionnaire | Cognitive reappraisal | 4.5 units on a scale | Standard Deviation 0.42 |
| Interpersonal Psychotherapy for Prevention | Emotion Regulation Questionnaire | Emotional suppression | 3.35 units on a scale | Standard Deviation 0.64 |
| Educational Clinical Monitoring | Emotion Regulation Questionnaire | Cognitive reappraisal | 4.02 units on a scale | Standard Deviation 0.91 |
| Educational Clinical Monitoring | Emotion Regulation Questionnaire | Emotional suppression | 4.62 units on a scale | Standard Deviation 1.32 |
Secondary
Emotion Regulation Questionnaire
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).
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Emotion Regulation Questionnaire | Cognitive reappraisal | 4 units on a scale | Standard Deviation 0 |
| Interpersonal Psychotherapy for Prevention | Emotion Regulation Questionnaire | Emotional suppression | 3 units on a scale | Standard Deviation 0 |
| Educational Clinical Monitoring | Emotion Regulation Questionnaire | Emotional suppression | 4.5 units on a scale | Standard Deviation 0.71 |
| Educational Clinical Monitoring | Emotion Regulation Questionnaire | Cognitive reappraisal | 3.5 units on a scale | Standard Deviation 0.71 |
Secondary
Emotion Regulation Questionnaire
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).
Time frame: 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)
Secondary
Family Assessment Device
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
Time frame: Measured at Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Family Assessment Device | 2.3 units on a scale | Standard Deviation 0.85 |
| Educational Clinical Monitoring | Family Assessment Device | 2.7 units on a scale | Standard Deviation 0.51 |
Secondary
Family History Screen
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).
Time frame: Measured at Week 1 (baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Family History Screen | Participants w/ parent'srelatives w/mood disorde | 2 participants |
| Interpersonal Psychotherapy for Prevention | Family History Screen | Participants w/ parent's relatives w/ anxiety | 2 participants |
| Interpersonal Psychotherapy for Prevention | Family History Screen | Participants w/ parents relatives w/substance use | 1 participants |
| Educational Clinical Monitoring | Family History Screen | Participants w/ parent'srelatives w/mood disorde | 4 participants |
| Educational Clinical Monitoring | Family History Screen | Participants w/ parent's relatives w/ anxiety | 3 participants |
| Educational Clinical Monitoring | Family History Screen | Participants w/ parents relatives w/substance use | 2 participants |
Secondary
Mood Disorder Questionnaire
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)
Time frame: Week 1
Population: This measure reflects parental mood.expressed as number of participants whose parent with BDI or BDII endorsed \> 7(1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interpersonal Psychotherapy for Prevention | Mood Disorder Questionnaire | 2 participants |
| Educational Clinical Monitoring | Mood Disorder Questionnaire | 4 participants |
Secondary
Patient Health Questionnaire
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.
Time frame: Measured at Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Patient Health Questionnaire | 12 units on a scale | Standard Deviation 2.8 |
| Educational Clinical Monitoring | Patient Health Questionnaire | 14.5 units on a scale | Standard Deviation 3.7 |
Secondary
Social Adjustment Scale - Self Report for Adolescents
(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.
Time frame: Measured at Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Social Adjustment Scale - Self Report for Adolescents | 1.9 units on a scale | Standard Deviation 0.42 |
| Educational Clinical Monitoring | Social Adjustment Scale - Self Report for Adolescents | 2.5 units on a scale | Standard Deviation 0.57 |
Secondary
Social Adjustment Scale - Self Report for Adolescents
(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.
Time frame: 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)
Secondary
Social Rhythm Metric Short Form
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.
Time frame: 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
Secondary
Treatment Credibility Scale
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)
Time frame: Measured at Week 1
Population: An ECM participant did not fill out her form
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interpersonal Psychotherapy for Prevention | Treatment Credibility Scale | 4 units on a scale | Standard Deviation 1.41 |
| Educational Clinical Monitoring | Treatment Credibility Scale | 3.75 units on a scale | Standard Deviation 0.96 |