Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot
This study is currently recruiting participants.
Verified July 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
Leslie Miller, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01591564
First received: May 2, 2012
Last updated: July 13, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD).
The investigators hypothesize that retention rates will be >80%,satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD intervention will have overall improvement in SMD symptoms.
| Condition | Intervention |
|---|---|
|
Severe Mood Dysregulation |
Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot |
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Retention rate [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.
Secondary Outcome Measures:
- Clinical Global Impressions Scale CGI-I (SMD) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]We will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.
| Estimated Enrollment: | 5 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)
Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria.
- Subject has an estimated IQ >70 on the Kaufman Brief Intelligence Test (KBIT-2)
- Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
- Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization.
- Children's Global Assessment Scale (CGAS) ≤ 60
Exclusion Criteria:
- Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
- Subject suffers from a concomitant medical or psychiatric co-morbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
- Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
- Pregnant females.
- Primary caretaker does not speak English
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591564
Contacts
| Contact: Leslie Miller, M.D. | 410-550-9014 |
Locations
| United States, Maryland | |
| Johns Hopkins Bayview Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: Leslie Miller, M.D. | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Leslie Miller, M.D. | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Leslie Miller, M.D., Assistant Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01591564 History of Changes |
| Other Study ID Numbers: | NA_00046454, K23MH090246 |
| Study First Received: | May 2, 2012 |
| Last Updated: | July 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
interpersonal psychotherapy severe mood dysregulation |
ClinicalTrials.gov processed this record on June 18, 2013