Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation (NCT01962623) | Clinical Trial Compass
CompletedNot Applicable
Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation
United States31 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.