NCT00000382

Brief Summary

The purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison group. Twelve-month-old infants and their mothers are assigned randomly (like tossing a coin) to receive 1 of 3 types of intervention for 12 months: 1) Services normally available in the community when a family is reported for child maltreatment (Child Protective Services, CPS); 2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention will be provided until the infant's second birthday. All mother-infant pairs (including comparison non-maltreated infants and their mothers) will be assessed when the infant is 12, 18, 24, 36, and 48 months old. Assessments will look at the effectiveness of the intervention in preventing child maltreatment, improving parenting, and reducing future abuse. The study will last for 3 years. Eligibility includes a mother and her 12-month-old child that has been abused by her (the mother) or the father. (Non-maltreated infants and their mothers also will be enrolled.)

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

4.9 years

First QC Date

November 2, 1999

Last Update Submit

November 5, 2013

Conditions

Keywords

Child AbuseFemaleHumanInfantMaleCaregiversPatient EducationPsychotherapyChild Abuse -- *prevention & control

Interventions

Eligibility Criteria

Age12 Months - 12 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Participants must have:
  • Infants that have been maltreated by their biological caregiver during their first year of life and who continue to reside with their maternal caregiver. (Non-maltreated infants and their mothers will also be enrolled.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Child Protective Services

Intervention Hierarchy (Ancestors)

Government AgenciesOrganizationsHealth Care Economics and Organizations

Study Officials

  • Dante Cicchetti, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

July 1, 1998

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

November 6, 2013

Record last verified: 2013-11