Bipolar DisorderNCT00338806

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

A study testing Interpersonal psychotherapy for prevention with adolescents and Educational clinical monitoring in people with Bipolar Disorder and Depression, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Bipolar Disorder, Depression
What is being tested?: Interpersonal psychotherapy for prevention with adolescents and Educational clinical monitoring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Nov 2006to Jul 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of BD I or II
Currently in partial or full remission from a depressive or manic episode
Under active clinical care
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

Show all 10Show fewer

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

Who cannot join

History of psychosis within 1 month of study entry
At risk for suicide within 1 month of study entry
Past major depressive or manic episode
Current or past psychosis
History of suicide attempts
Current substance use disorder
Use of psychotropic medications and other medications that might impact mood (e.g., steroids)

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Official title: Prevention for Symptomatic Offspring of Bipolar Parents

This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.

Read the 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.

Conditions: Bipolar Disorder, Depression
Being tested: Interpersonal psychotherapy for prevention with adolescents, Educational clinical monitoring
Keywords: Prevention, Mood Disorders, Unipolar Depression
Medical subject headings: Bipolar Disorder, Depression, Mood Disorders, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interpersonal psychotherapy for prevention with adolescentsBehavioural
Also called IPT-PA
Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.
Educational clinical monitoringBehavioural
Also called ECM
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.

Study groups in NCT00338806
Study group	Role	What they receive
Interpersonal Psychotherapy-Prevention	Experimental	Participants will receive interpersonal psychotherapy for prevention with adolescents Receives: Behavioral: Interpersonal psychotherapy for prevention with adolescents
Educational and Clinical Monitoring	Active comparator	Participants will receive educational clinical monitoring Receives: Behavioral: Educational clinical monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 18 months
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.
Measured: Week 12
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 18 months
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.
Measured: Week 12
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 18 months
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.
Measured: Week 12
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.
Measured: 6 months
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.
Measured: 12 months
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.
Measured: 18 months

Secondary outcomes (12)

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
Measured: Measured at Week 12
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).
Measured: Measured at Week 12
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).
Measured: 6 months
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).
Measured: 12 months and 18 months
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
Measured: Measured at Week 12
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).
Measured: Measured at Week 1 (baseline)
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)
Measured: Week 1
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.
Measured: Measured at Week 1
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.
Measured: Measured at Week 12
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.
Measured: 12 months and 18 months
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.
Measured: Measured at Week 12 and Months 6, 12, and 18 post-treatment
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)
Measured: Measured at Week 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jul 2012

First posted20 Jun 2006 (estimated)
Study startNov 2006
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00338806
Sponsor's protocol ID: #5067
Other IDs: K23MH071530
Status last verified: Jul 2017
First submitted: 16 Jun 2006
Last updated: 15 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention for Symptomatic Offspring of Bipolar Parents
ClinicalTrials.gov ID: NCT00338806
Acronym / sponsor ID: #5067
Conditions: Bipolar Disorder, Depression
Keywords: Prevention, Mood Disorders, Unipolar Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2006
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 20 Jun 2006 (estimated)
Results: Posted 15 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Interpersonal Psychotherapy-Prevention	Experimental	Behavioral: Interpersonal psychotherapy for prevention with adolescentsParticipants will receive interpersonal psychotherapy for prevention with adolescents
Educational and Clinical Monitoring	Active comparator	Behavioral: Educational clinical monitoringParticipants will receive educational clinical monitoring

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Diagnosis of BD I or II
Currently in partial or full remission from a depressive or manic episode
Under active clinical care
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

Key exclusion criteria (7 listed)

History of psychosis within 1 month of study entry
At risk for suicide within 1 month of study entry
Past major depressive or manic episode
Current or past psychosis
History of suicide attempts

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interpersonal psychotherapy for prevention with adolescentsAlso: IPT-PAIndividual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component.	Behavioural	Interpersonal Psychotherapy-Prevention
Educational clinical monitoringAlso: ECMEducational 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.	Behavioural	Educational and Clinical Monitoring

Primary outcome

K SADS-Present Version (KSADS-P)
Time frame: 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.
K SADS-Present Version (KSADS-P)
Time frame: 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.
K SADS-Present Version (KSADS-P)
Time frame: 12 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.
K SADS-Present Version (KSADS-P)
Time frame: 18 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.
Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: 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 Depression Rating Scale-Revised (CDRS-R)
Time frame: 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.
Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: 12 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.
Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: 18 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.
Children's Global Assessment Scale (C-GAS)
Time frame: 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.
Children's Global Assessment Scale (C-GAS)
Time frame: 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.
Children's Global Assessment Scale (C-GAS)
Time frame: 12 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.
Children's Global Assessment Scale (C-GAS)
Time frame: 18 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.
Young Mania Rating Scale (YMRS)
Time frame: 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.
Young Mania Rating Scale (YMRS)
Time frame: 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.
Young Mania Rating Scale (YMRS)
Time frame: 12 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.
Young Mania Rating Scale (YMRS)
Time frame: 18 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.

12 secondary outcomes

Attitudes Toward Treatment Questionnaire
Time frame: Measured at Week 12
Emotion Regulation Questionnaire
Time frame: Measured at Week 12
Emotion Regulation Questionnaire
Time frame: 6 months
Emotion Regulation Questionnaire
Time frame: 12 months and 18 months
Family Assessment Device
Time frame: Measured at Week 12
Family History Screen
Time frame: Measured at Week 1 (baseline)
Mood Disorder Questionnaire
Time frame: Week 1
Patient Health Questionnaire
Time frame: Measured at Week 1
Social Adjustment Scale - Self Report for Adolescents
Time frame: Measured at Week 12
Social Adjustment Scale - Self Report for Adolescents
Time frame: 12 months and 18 months
Social Rhythm Metric Short Form
Time frame: Measured at Week 12 and Months 6, 12, and 18 post-treatment
Treatment Credibility Scale
Time frame: Measured at Week 1

Results and safety

Results posted to the registry on 15 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interpersonal Psychotherapy for Prevention	2	2
Educational Clinical Monitoring	5	4

Primary outcome: K SADS-Present Version (KSADS-P)

Time frame: 12 weeks. Number. Unit: participants

Measure	Interpersonal Psychotherapy for Prevention n = 2	Educational Clinical Monitoring n = 4
Participants with sub-syndromal depression	0	2
Participants with sub-syndromal mania	1	0
Participants with current Oppositional defiant dis	1	1
Participants with current Depression	0	1
Participants with current Specific phobia	1	0
Participants with current subsyndromal PTSD	0	1

Primary outcome: K SADS-Present Version (KSADS-P)

Time frame: 6 months. Number. Unit: participants

Measure	Interpersonal Psychotherapy-Prevention n = 1	Educational and Clinical Monitoring n = 2
Participants with sub-syndromal depression	0	1
Participants with Specific phobia	1	0
Participant with major depression	0	1

Primary outcome: K SADS-Present Version (KSADS-P)

Time frame: 12 months. Number. Unit: participants

Measure	Interpersonal Psychotherapy for Prevention n = 0	Educational Clinical Monitoring n = 1
Participants with sub-syndromal depression	–	1
Participants with sub-syndromal mania	–	1

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

Primary outcome: K SADS-Present Version (KSADS-P)

Time frame: 18 months. Number. Unit: participants

Measure	Interpersonal Psychotherapy for Prevention n = 1	Educational Clinical Monitoring n = 0
Participants with sub-syndromal depression	0	–
Participant with specific phobia	1	–

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

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 21 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interpersonal Psychotherapy for Prevention	0 of 2 (0%)	0 of 2 (0%)	Not reported
Educational Clinical Monitoring	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitations include a very small sample size due to recruitment difficulty. In addition, participation with follow-up evaluations was poor.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Verdeli, PhD principal investigator

New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

K SADS-Present Version (KSADS-P) (time frame: 12 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00338806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.