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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00338806
First Posted: June 20, 2006
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
  Purpose
This study will develop strategies for early detection and prevention of mood disorders and associated impairment in adolescent children of parents with bipolar disorder.

Condition Intervention
Bipolar Disorder Depression Behavioral: Interpersonal psychotherapy for prevention with adolescents Behavioral: Educational clinical monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention for Symptomatic Offspring of Bipolar Parents

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Attitudes Toward Treatment Questionnaire [ Time Frame: 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

  • Emotion Regulation Questionnaire [ Time Frame: 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).


  • Emotion Regulation Questionnaire [ Time Frame: 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).


  • Emotion Regulation Questionnaire [ Time Frame: 12 months and 18 months ]

    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 [ Time Frame: 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 [ Time Frame: 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).

  • Mood Disorder Questionnaire [ Time Frame: 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 [ Time Frame: 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.

  • Social Adjustment Scale - Self Report for Adolescents [ Time Frame: 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.

  • Social Adjustment Scale - Self Report for Adolescents [ Time Frame: 12 months and 18 months ]
    (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.

  • Social Rhythm Metric Short Form [ Time Frame: 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 [ Time Frame: 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)


Enrollment: 7
Study Start Date: November 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy-Prevention
Participants will receive interpersonal psychotherapy for prevention with adolescents
Behavioral: 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.
Other Name: IPT-PA
Active Comparator: Educational and Clinical Monitoring
Participants will receive educational clinical monitoring
Behavioral: 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.
Other Name: ECM

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria for Adolescents:

  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338806


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Helen Verdeli, PhD New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00338806     History of Changes
Other Study ID Numbers: #5067
K23MH071530 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2006
First Posted: June 20, 2006
Results First Submitted: June 14, 2016
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:
Prevention
Mood Disorders
Unipolar Depression

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders