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

Child Maltreatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304719
• Other study ID #: 092506B3F
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: May 13, 2013
• Start date: October 2007
• Est. completion date: August 2011

Study information

• Verified date: May 2013
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Maltreatment

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child maltreatment reports		18 months	No