Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Conditions
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Severe Mood Dysregulation

Intervention / Treatment
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* Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: therapy<br>All participants will receive the intervention. | Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)<br>* Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial. | 20 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interpersonal psychotherapy, severe mood dysregulation