Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

NCT ID: NCT01591564

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

therapy

All participants will receive the intervention.

Group Type: OTHER

Interpersonal Psychotherapy for youth with SMD (IPT-SMD)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Leslie Miller, M.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leslie Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

K23MH090246

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00046454

Identifier Type: -

Identifier Source: org_study_id