- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01294475
Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The current project will employ a 3-group experimental design with random assignment of parents to one of three groups: Planned Activities Training as usual (PAT); Cellular Phone Enhanced PAT (CPAT), or a no-intervention control group. Two cohorts of high-risk mother-child dyads (low education or mother adolescent at time of birth) will be recruited. In years 1 and 2, the first cohort of participants will be recruited in Kansas City, MO and South Bend, IN from an ongoing longitudinal descriptive study of child neglect, which has tracked risk and protective factors since the child's birth (n=180). During years 3 and 4, a second cohort of matched high risk mothers (operationally defined the same as for cohort 1) will be recruited from Head Start programs within the same two communities (n=180). Families in both cohorts will be enrolled when the first family child is between the ages of 4 and 6 years.
Participants assigned to the intervention groups will receive intervention services in the home setting and will be assessed prior to the intervention, as well as at 1-, 6-, and 12- month post-intervention time points. The control group participants will complete assessments at similar time points to the intervention groups. Several outcomes will be examined in order to measure intervention effects, including child maltreatment risk and occurrences, parent behaviors, and child behaviors. These outcomes will be collected utilizing a multi-method approach that will involve parent interview, parent-report and self-report measures, mother-child observation, and review of local CPS system records. For those parents participating in an intervention group, data will also be collected on maternal engagement, retention, fidelity, and dosage with regard to the intervention. Lastly, program and participant costs will be examined to determine the cost-effectiveness of including a technological component with this existing parenting program. It is expected that the knowledge generated through this study will aid in the improvement of parenting interventions targeting the prevention of child maltreatment.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Kansas
-
Lawrence, Kansas, Forente stater, 66045
- University of Kansas
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion:
- Women between the ages of 15-18 at the time of their first child's birth OR between the ages of 22-35 years at the time of their first child's birth, with no formal education beyond high school or GED
- Mothers' oldest biological child should be between 4 and 6 years
- Families anticipate living in the 50 mile vicinity of Kansas City or South Bend for the next 18 months
- Primary caregiver should be functionally literate.
- Must speak English or Spanish fluently.
Exclusion:
- Mother has a major medical illness that could interfere with her ability to participate in a 2-year project
- Mother currently lives in a treatment program or rehab center
- Mother has a serious mental illness
- Mother lives in a group home or correctional program.
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: Cell Phone Enhanced Parent Training
Cell phones will be provided to mothers participating in Planned Activities Training.
|
Mothers will be provided a parenting intervention, Planned Activities Training (PAT).
Some of the mothers will receive the PAT intervention enhanced with a cell phone.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mishandling av barn
Tidsramme: 12 måneder
|
12 måneder
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Judy Carta, Ph.D., University of Kansas
Publikasjoner og nyttige lenker
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
Andre studie-ID-numre
- CDC-NCIPC-5054
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