- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00050557
Family Psychoeducation for Children With Mood Disorders
Family Psychoeducation: Efficacy in Child Mood Disorders
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Mood disorders among youth are a major health concern. Existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. This 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders.
In this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. Parents also practice problem-solving and communication skills for symptom management. Children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. Children also learn and practice anger management, problem-solving, and communication skills.
Patients and their families are randomly assigned to 1 of 2 groups. The first group receives 8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list control in which participants receive only TAU. Patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. Anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. Caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. The extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. A comprehensive assessment is conducted at study entry and 1 year later.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Ohio
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Columbus, Ohio, Forente stater, 43210
- Ohio State University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)
- IQ greater than 70
- At least one parent/caregiver willing to participate in the study
- Able to attend six or more of the eight treatment sessions with at least 1 parent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
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MFPG will include 8 weekly 90-minute group therapy sessions.
Participants will receive standard care for mood disorders.
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Aktiv komparator: 2
Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
|
MFPG will include 8 weekly 90-minute group therapy sessions.
Participants will receive standard care for mood disorders.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mood Severity Index
Tidsramme: Measured at Months 6 and 12
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Measured at Months 6 and 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rage Index (MRS irritability + disruptive-aggressive items)
Tidsramme: Measured at Months 6 and 12
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Measured at Months 6 and 12
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mary A. Fristad, PhD, Ohio State University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Boylan K, Macpherson HA, Fristad MA. Examination of disruptive behavior outcomes and moderation in a randomized psychotherapy trial for mood disorders. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):699-708. doi: 10.1016/j.jaac.2013.04.014.
- Fristad MA, Verducci JS, Walters K, Young ME. Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders. Arch Gen Psychiatry. 2009 Sep;66(9):1013-21. doi: 10.1001/archgenpsychiatry.2009.112.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01MH061512 (U.S. NIH-stipend/kontrakt)
- DSIR CT-S
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Multifamily Psychoeducation Group (MFPG)
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University of ArizonaInstitute for Mental Health ResearchFullførtSchizofreni | Schizoaffektiv lidelse | Major depresjon med psykotiske egenskaper | Bipolar lidelse med psykotiske egenskaper | Psykotisk lidelse ikke spesifisert på annen måte (NOS) | Nylig oppstått psykoseForente stater