Preventing Child Abuse in Infants

November 5, 2013 updated by: University of Rochester

Preventive Intervention for Maltreated Infants

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.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the relative effectiveness of 2 theoretically-informed approaches to preventing the adverse sequelae of maltreatment in infants: Psychoeducational Home Visitation (PHV) and Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers serve as a comparison.

Maltreated infants and their mothers are randomly assigned to 1 of 3 types of intervention for 12 months: 1) Services routinely 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 is provided until the infant's second birthday. All mother-infant dyads (including comparison non-maltreated infants and their mothers) participate in baseline assessments at the infant's age of 12 months. Subsequent assessments occur at 18, 24, 36, and 48 months of age. Assessments measure three major areas: 1) family-ecological variables; 2) maternal functioning and parenting; and 3) child functioning and stage-salient issues. CPS records are monitored annually across all groups to determine whether any reports of maltreatment have been filed.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Dante Cicchetti, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01MH054643 (U.S. NIH Grant/Contract)
  • DSIR CT-P (Other Identifier: NIMH)

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.

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