Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Not Applicable

Completed

• Conditions: Severe Mood Dysregulation
• Interventions: Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)

• Registration Number: NCT01591564
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-04
• Study Start: 2012-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy	Interpersonal Psychotherapy for youth with SMD (IPT-SMD)	All participants will receive the intervention.

Primary Outcome Measures

Name	Time	Method
Retention rate	20 weeks	We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions Scale CGI-I (SMD)	20 weeks	We will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States