Mental Health Services for Foster and Adopted Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00056303|
Recruitment Status : Completed
First Posted : March 11, 2003
Last Update Posted : December 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Problem Behaviors Attention Deficit Hyperactivity Disorder Depression||Behavioral: Attachment and Biobehavioral Catch-up Behavioral: Developmental Education for Families||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Specialized Mental Health Services for Foster Infants|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Attachment and Biobehavioral Catch-up
Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.
Behavioral: 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
Developmental Education for Families targets providing cognitive stimulation to their children.
Behavioral: Developmental Education for Families
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
- Attachment [ Time Frame: Annually ]The Preschool Strange Situation is conducted annually.
- 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.
- Diurnal production of cortisol [ Time Frame: Annually ]Three days of saliva sampling at wake-up and bedtime.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056303
|United States, Delaware|
|University of Delaware|
|Newark, Delaware, United States, 19716|
|Principal Investigator:||Mary Dozier, Ph.D.||University of Delaware|