- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01294475
Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Kansas
-
Lawrence, Kansas, United States, 66045
- University of Kansas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child Maltreatment
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Judy Carta, Ph.D., University of Kansas
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CDC-NCIPC-5054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Maltreatment
-
Karolinska InstitutetCompletedChild Abuse | Child MaltreatmentSweden
-
Oral Health Centre of Expertise in Western NorwayOral Health Center of Expertise Rogaland, Norway; Childrens advocacy center... and other collaboratorsRecruitingChild Abuse | Child Neglect | Child MaltreatmentNorway
-
University of Cape TownParenting for Lifelong Health; Mikhulu Trust; Clowns Without Borders South Africa and other collaboratorsNot yet recruitingChild MaltreatmentZimbabwe
-
University of Maryland, BaltimoreUniversity of California, San Diego; Chestnut Health SystemsCompleted
-
National Society for the Prevention of Cruelty...Department of Education Northern IrelandCompletedEvaluating the Effectiveness of Keeping Safe - a School Based Intervention Aimed at Preventing AbuseChild MaltreatmentUnited Kingdom
-
Georgia State UniversityCenters for Disease Control and Prevention; University of GeorgiaCompletedChild MaltreatmentUnited States
-
NYU Langone HealthWithdrawn
-
Stony Brook UniversityUniversity of DelawareNot yet recruitingChild Maltreatment
-
Daniel WhitakerPatient-Centered Outcomes Research InstituteCompletedChild MaltreatmentUnited States
-
University of DelawareCompletedMaltreatment, Child
Clinical Trials on Planned Activities Training
-
Cumhuriyet UniversityActive, not recruitingAnxiety | Menopause | Menopausal Symptoms | Perceived StressTurkey (Türkiye)
-
Ankara UniversityNot yet recruitingDysmenorrhea PrimaryTurkey
-
Ankara UniversityNot yet recruiting
-
Bartın UnıversityThe Scientific and Technological Research Council of TurkeyCompleted
-
Koç UniversityCompletedDiabetes Mellitus, GestationalTurkey
-
Saglik Bilimleri UniversitesiCompletedBreast Cancer | Chemotherapy-related Cognitive ImpairmentTurkey (Türkiye)
-
Universidade Federal do Rio de JaneiroCompleted
-
University of Geneva, SwitzerlandNot yet recruitingCognition | Ageing | Well-Being, PsychologicalSwitzerland
-
Clemson UniversityNational Institute on Aging (NIA)CompletedCognitive Impairment | Dementia | Cognitive Change | Healthy AgingUnited States
-
Université de Reims Champagne-ArdenneNot yet recruitingImpact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder (RAMAu)Autistic Spectrum Disorder