NCT01304719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

3.8 years

First QC Date

February 10, 2011

Last Update Submit

May 13, 2013

Conditions

Child Maltreatment

Outcome Measures

Primary Outcomes (1)

  • Child maltreatment reports

    18 months

Study Arms (3)

Computer Assisted home visitation

EXPERIMENTAL

Home visitation with computer modules added

Behavioral: Computer Assisted Healthy Families America Home Visitation

Home Visitation TAU

EXPERIMENTAL

Home Visitation Treatment as Usual

Behavioral: Healthy Families America Home Visitation

Community Referral

NO INTERVENTION

Community Referral

Interventions

Computer Assisted Healthy Families America Home VisitationBEHAVIORAL

Computer modules added to home visitation protocol for Healthy Families America

Computer Assisted home visitation
Healthy Families America Home VisitationBEHAVIORAL

Healthy Families America Home Visitation Treatment as Usual

Home Visitation TAU

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery.
  • Mothers have not completed any prior post-partum treatment plan.
  • Participants must have functional cognitive abilities.
  • Premature infants have to be released from hospital care within 6 weeks of birth.
  • Participants must be able to communicate in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Study Officials

  • Steven Ondersma, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 25, 2011

Study Start

October 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

US(1)