A Phase 1 interventional study of Attachment and Biobehavioral Catch-up and Developmental Education for Families in Problem Behaviors, Attention Deficit Hyperactivity Disorder and Depression, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 20 Months to 36 Months. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by University of Delaware · Phase 1, Interventional, and Prevention
This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 220 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
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
Developmental Education for Families targets providing cognitive stimulation to their children.
Behavioral: Developmental Education for Families
Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
Attachment
The Preschool Strange Situation is conducted annually.
Time frame: Annually
Executive Functioning
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.
Time frame: Annually
Diurnal production of cortisol
Three days of saliva sampling at wake-up and bedtime.
Time frame: Annually
Plan to share: No
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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of Delaware