- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00149812
A Clinic-based Prevention Program for Families of Depressed Mothers
A Clinic-based Program for Families of Depressed Mothers
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Children of depressed mothers are at high risk for developing serious psychiatric disorders. While genetics can account for about 34% of cases of childhood psychiatric disorders, children of depressed parents are at an even greater risk of developing mental disorders. The "Keeping Families Strong" program, or KFS, was built from evidence-based prevention programs. Its goal is to provide educational, cognitive, and behavioral interventions. These interventions are meant to enhance understanding about depression and its effects on families, improve communication within families, enhance social support, increase positive and consistent parenting, and improve child coping. This will likely improve the children's mental health, as well as positively affect the short- and long-term outcomes of parents recovering from a depressive episode. This study will evaluate the effectiveness of the KFS program in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.
This 10-week, open-label program will involve 12 meetings, lasting 2 hours each. The parents and the children will attend separate meetings each week on the same nights. Children are prone to take on their parents' responsibilities to prevent them from becoming depressed. In order to avoid this, the children's meetings will focus on clarifying role responsibilities. There will be two additional follow-up meetings in the 3 months following completion of the program. All caregivers are encouraged to participate, including depressed fathers.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins Bloomberg School of Public Health
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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:
- Parent in treatment for depression
- Parent in maintenance phase of treatment
Exclusion Criteria:
- Active substance abuse
- Substantial cognitive impairment
- Psychosis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Intervention
Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks
Tidsramme: 10 weeks
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10 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period
Tidsramme: 1 year
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1 year
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anne W. Riley, PhD, Bloomberg School of Public Health, Johns Hopkins University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Riley AW, Valdez CR, Barrueco S, Mills C, Beardslee W, Sandler I, Rawal P. Development of a family-based program to reduce risk and promote resilience among families affected by maternal depression: theoretical basis and program description. Clin Child Fam Psychol Rev. 2008 Jun;11(1-2):12-29. doi: 10.1007/s10567-008-0030-3.
- Valdez CR, Mills CL, Barrueco S, Leis J, Riley AW. A Pilot Study of a Family-Focused Intervention for Children and Families Affected by Maternal Depression. J Fam Ther. 2011 Feb;33(1):3-19. doi: 10.1111/j.1467-6427.2010.00529.x.
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
- R21MH067861 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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