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Family Psychoeducation for Children With Mood Disorders

2. maj 2012 opdateret af: Mary Fristad

Family Psychoeducation: Efficacy in Child Mood Disorders

The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

165

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
MFPG will include 8 weekly 90-minute group therapy sessions.
Participants will receive standard care for mood disorders.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mood Severity Index
Tidsramme: Measured at Months 6 and 12
Measured at Months 6 and 12

Sekundære resultatmål

Resultatmål
Tidsramme
Rage Index (MRS irritability + disruptive-aggressive items)
Tidsramme: Measured at Months 6 and 12
Measured at Months 6 and 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Mary A. Fristad, PhD, Ohio State University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2001

Primær færdiggørelse (Faktiske)

1. september 2006

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

13. december 2002

Først indsendt, der opfyldte QC-kriterier

13. december 2002

Først opslået (Skøn)

16. december 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. maj 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2012

Sidst verificeret

1. maj 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01MH061512 (U.S. NIH-bevilling/kontrakt)
  • DSIR CT-S

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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