Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation

NCT01962623 | Completed DMC

• 2 other identifiers: NA_00083893K23MH090246
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility and acceptability of utilizing an adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood dysregulation disorder (DMDD). 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 intervention will have overall improvement in SMD/DMDD symptoms.

Conditions

Severe Mood Dysregulation

Keywords

Severe Mood Dysregulation; Mood Disorders; Irritability; Disruptive Mood Dysregulation Disorder; Interpersonal Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Retention rate

  To describe/assess feasibility of IPT-MBD, investigators will look at ease of recruitment and retention rate goal of at least 80%. Investigators will collect data on the number of subjects recruited, enrolled, and who followed the protocol for 24 weeks. Investigators will comment on adherence to the overall study, as well as to specific treatment visits.

  24 weeks

Secondary Outcomes (2)

• Clinical Global Impressions Scale for SMD/DMDD (CGI-SMD/DMDD)

  24 weeks

• Satisfaction

  24 weeks

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants who are not randomly assigned to the IPT-MBD group will continue with treatment at usual, which is considered routine care.

Other: IPT-MBD

IPT-MBD

OTHER

Weekly Interpersonal Therapy for SMD/DMDD (IPT-MBD) sessions, which emphasizes building skills in managing relationships, helping with problem solving, strengthening communication skills and other skills.

Other: IPT-MBD

Interventions

IPT-MBD OTHER

IPT-MBD is a modified form of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), which emphasizes building skills in managing relationships, helping with problem solving, and strengthening communication skills.

Also known as: IPT for Mood and Behavior Dysregulation

IPT-MBD; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects, ages 12 to 17 years, who meet criteria for severe mood dysregulation (SMD) as defined by NIMH criteria or for disruptive mood dysregulation disorder (DMDD).
• Subject has an estimated IQ \>70 on the Kaufman Brief Intelligence Test (KBIT-
• 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.
• Children's Global Assessment Scale (CGAS) ≤ 60
• CGI-S (SMD) ≥ 4
• Participant and guardian must agree to have therapy sessions audiotaped for training purposes.

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 comorbidity 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).
• Primary caretaker does not speak English or is not capable of completing study measures.
• Pregnant females.

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins University Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Mood Disorders

Interventions

adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Leslie Miller, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

US (1)