Skip to main content
OpenTrials
Completed

NCT Number: NCT00056303

Mental Health Services for Foster and Adopted Children

This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Problem Behaviors Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Child Behavior Depression Mental Disorders Neurodevelopmental Disorders Problem Behavior

Age range

20 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.

Children are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Toddler placed into foster care
  • Resident of Delaware and surrounding counties in Pennsylvania and Maryland

Exclusion criteria

  • Significant medical problems

Treatment and study plan

Attachment and Biobehavioral Catch-Up

Behavioral

Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.

Developmental Education for Families

Behavioral

Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Primary outcomes

  1. Attachment

    Time frame: Annually

    The Preschool Strange Situation is conducted annually.

Secondary outcomes

  1. Executive Functioning

    Time frame: Annually

    Disruptive Behaviors-Diagnostic Observation Schedule (DB-DOS) is used to assess problem behaviors. The DB-DOS consists of a series of challenging tasks that ask the child to inhibit prepotent behaviors and regulate emotions.

  2. Diurnal production of cortisol

    Time frame: Annually

    Three days of saliva sampling at wake-up and bedtime.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Specialized Mental Health Services for Foster Infants

Important dates

Study start
2002
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2003
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.