Preventing Child Abuse in Infants

NCT ID: NCT00000382

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2003-06-30

Brief Summary

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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.)

Detailed Description

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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.

Conditions

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Child Abuse

Keywords

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Child Abuse Female Human Infant Male Caregivers Patient Education Psychotherapy Child Abuse -- *prevention & control

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Interventions

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Infant-Parent Psychotherapy

Intervention Type BEHAVIORAL

Child Protective Services

Intervention Type BEHAVIORAL

Psychoeducational Home Visitation

Intervention Type BEHAVIORAL

Parent Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

12 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Principal Investigators

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Dante Cicchetti, PhD

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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R01MH054643

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR CT-P

Identifier Type: -

Identifier Source: secondary_id

R01MH054643

Identifier Type: NIH

Identifier Source: org_study_id

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