Mental Health Services for Foster and Adopted Children

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

Detailed Description
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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.

Official Title
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Specialized Mental Health Services for Foster Infants

Conditions
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Problem Behaviors, Attention Deficit Hyperactivity Disorder, Depression

Intervention / Treatment
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* Behavioral: Attachment and Biobehavioral Catch-up
* Behavioral: Developmental Education for Families


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

Ages Eligible for Study
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Minimum Age: 20 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attachment and Biobehavioral Catch-up<br>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<br>* Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.<br>|
| Active Comparator: Developmental Education for Families<br>Developmental Education for Families targets providing cognitive stimulation to their children. | Behavioral: Developmental Education for Families<br>* Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attachment | The Preschool Strange Situation is conducted annually. | Annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Annually | 
| Diurnal production of cortisol | Three days of saliva sampling at wake-up and bedtime. | Annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Attachment, Intervention