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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00056303 |
Purpose
This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.
| Condition | Intervention | Phase |
|---|---|---|
|
Mental Health Services Foster Home Care Adoption Family Relationships |
Behavioral: Attachment and Biobehavioral Catch-up |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Specialized Mental Health Services for Foster Infants |
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2002 |
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 education. Caregivers receiving the relational intervention are trained to interpret children's behaviors appropriately, to provide nurturing care, and to respond sensitively to their children's behavioral and emotional cues. Caregivers in the treatment control group receive training designed to enhance children's intellectual development. Caregivers in both groups will receive 10 home visits. Observations of children and behavior checklists are used to assess participants.
Eligibility| Ages Eligible for Study: | up to 20 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | R01 MH52135, DSIR 84-CTCT |
| Study First Received: | March 10, 2003 |
| Last Updated: | February 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00056303 History of Changes |
| Health Authority: | United States: Federal Government |