A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01304719
Collaborator
(none)
413
1
3
46
9

Study Details

Study Description

Brief Summary

The current protocol aims to examine the effects of a computer-based intervention used in conjunction with existing Healthy Families America (HFA) home visitation programs on the challenges related to participant enrollment, retention, and motivation as well as parent and child outcomes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computer Assisted Healthy Families America Home Visitation
  • Behavioral: Healthy Families America Home Visitation
N/A

Detailed Description

The present study aims to determine whether a computer-based intervention can provide augmentation of home visiting services to decrease the risk of child maltreatment. The computer-based software includes modules on motivation, Cognitive Retraining, and elements of the ecobehavioral SafeCare approach. A total of 420 mother-infant dyads from four Healthy Families America (HFA) sites will be randomly assigned to either treatment as usual, software-supplemented home visitation, or community control conditions. For families in the software-supplemented condition, home visitors will present the software to parents via a Tablet PC during regular home visits. All parents will be followed-up at 6, 12, and 18 months by independent and blinded research assistants. Parents are evaluated for maltreatment and maltreatment risks as measured by self-report, home visitor report, blinded independent observers, and statewide CPS data. If validated, the proposed intervention can provide augmentation of home visiting services with unprecedented ease of dissemination, at negligible additional cost, and with limitless potential for further development.

Study Design

Study Type:
Interventional
Actual Enrollment :
413 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Computer Assisted home visitation

Home visitation with computer modules added

Behavioral: Computer Assisted Healthy Families America Home Visitation
Computer modules added to home visitation protocol for Healthy Families America

Experimental: Home Visitation TAU

Home Visitation Treatment as Usual

Behavioral: Healthy Families America Home Visitation
Healthy Families America Home Visitation Treatment as Usual

No Intervention: Community Referral

Community Referral

Outcome Measures

Primary Outcome Measures

  1. Child maltreatment reports [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Pregnant or post-partum mothers who are eligible (i.e., score 25 or greater on the Kempe Family Stress Checklist and are not involved in CPS open case investigation at the time of HFA participation) and willing to participate in the HFA program are eligible to participate in the current study, with the following restrictions:

  1. Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery.

  2. Mothers have not completed any prior post-partum treatment plan.

  3. Participants must have functional cognitive abilities.

  4. Premature infants have to be released from hospital care within 6 weeks of birth.

  5. Participants must be able to communicate in English.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Steven Ondersma, Ph.D., Wayne State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01304719
Other Study ID Numbers:
  • 092506B3F
First Posted:
Feb 25, 2011
Last Update Posted:
May 15, 2013
Last Verified:
May 1, 2013

Study Results

No Results Posted as of May 15, 2013