- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00890331
Prevention of Self-care Deterioration in Early Adolescents With Diabetes
Family Teamwork and Coping Skills Prevention Program
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results.
The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments.
The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources.
The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20010
- Children's National Medical Center
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Virginia
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Richmond, Virginia, Forente stater, 23284
- Virginia Commonwealth 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:
- Seen for Diabetes care at Virginia Commonwealth University or Children's National Medical Center
- Child ages 11-14
- Type 1 Diabetes
- Fluent in English
- Ability to comprehend and complete questionnaires independently
Exclusion Criteria:
- The presence of any other major disease
- The presence of any severe diabetic complications which could impair test performance
- Use of any medication that affects the CNS other than insulin
- Inability to speak/comprehend and read English
- Placement in special classes for the mentally disabled
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Diabetes utdanning
|
Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments.
This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
|
Eksperimentell: TeamWork CS Sessions
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The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care.
Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted.
Families meet with a study interventionist in conjunction with four consecutive medical appointments.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Parental involvement and Disease care behaviors
Tidsramme: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
|
Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Glycohemoglobin levels, Adverse effects and Blood glucose variability
Tidsramme: Baseline, 3, 6, 9, 12, 15, 18, and 24 months
|
Baseline, 3, 6, 9, 12, 15, 18, and 24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Randi Streisand, Ph.D., Children's National Research Institute
- Hovedetterforsker: Clarissa S Holmes, Ph.D., Virginia Commonwealth University
- Studieleder: Rusan Chen, Ph.D., Georgetown University
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
- DK70917
- R01DK070917 (U.S. NIH-stipend/kontrakt)
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. .
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