Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

NCT01591564 | Completed DMC

• 2 other identifiers: NA_00046454K23MH090246
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Mood Dysregulation

Keywords

interpersonal psychotherapy; severe mood dysregulation

Outcome Measures

Primary Outcomes (1)

• Retention rate

  We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.

  20 weeks

Secondary Outcomes (1)

• Clinical Global Impressions Scale CGI-I (SMD)

  20 weeks

Study Arms (1)

therapy

OTHER

All participants will receive the intervention.

Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)

Interventions

Interpersonal Psychotherapy for youth with SMD (IPT-SMD) BEHAVIORAL

Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.

therapy

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

Interpersonal Psychotherapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leslie Miller, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)