This trial has been completed.

Conditions problem behaviors, attention deficit hyperactivity disorder, depression
Treatments attachment and biobehavioral catch-up, developmental education for families
Phase phase 1
Sponsor University of Delaware
Collaborator National Institute of Mental Health (NIMH)
Start date December 2002
End date December 2016
Trial size 220 participants
Trial identifier NCT00056303, DSIR 84-CTCT, R01MH052135


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.
attachment and biobehavioral catch-up
Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.
(Active Comparator)
Developmental Education for Families targets providing cognitive stimulation to their children.
developmental education for families
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Primary Outcomes

time frame: Annually

Secondary Outcomes

Executive Functioning
time frame: Annually
Diurnal production of cortisol
time frame: Annually

Eligibility Criteria

Male or female participants from 20 months up to 36 months old.

Inclusion Criteria: - Toddler placed into foster care - Resident of Delaware and surrounding counties in Pennsylvania and Maryland Exclusion Criteria: - Significant medical problems

Additional Information

Official title Specialized Mental Health Services for Foster Infants
Principal investigator Mary Dozier, Ph.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Delaware.