About this trial
The purpose of this study is to determine the effects of early intervention (placement into foster care, and a caregiving training) on physical, cognitive, social and brain development and psychiatric symptomatology in children place in out-of-home care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
newly entering the institution system in and near São Paulo, Brazil, and the institution director or foster parent is the guardian at the time of baseline,
at the time of baseline assessment the child is less than 24 months old,
the child's birth weight must be at or above 2500 grams; none should be small or large for dates.
Disqualifiers
the child does not have a neurological or other genetic condition that severely impairs typical development (e.g. Cerebral Palsy, Fetal Alcohol Syndrome, Down Syndrome)
the child is below 2500 grams.
Trial design
Parallel
Treatments tested in this trial
Foster Care
Other interventionUpon entry into the Child Protection System, if the child is assigned to one of the districts participating in the RCT, the court will notify the study team. Children that have been randomly assigned to Foster Care will be placed in a foster home within 48 hours of referral to the Family Court/Child Protection System. Children and Foster Parents will receive biweekly visits from Social Workers. Children and Foster parents will also participate in the caregiving intervention described below. Children will remain in the placement until such time as the social workers, psychologists and Family Court Judge determine that one of the following outcomes is appropriate: reunification with biological family or adoption.
Caregiving Intervention
BehavioralDuring AVI an intervenor meets with a caregiver (foster parent or caregiver at the institution) and child in the home environment. During each session, the intervenor videotapes the caregiver and child doing play-based activities. During that meeting, the intervenor reviews the videos with the caregiver and provides positive, constructive feedback to the caregiver. AVI is aimed at increasing sensitivity in parents/caregivers in order to encourage positive interactions. The guiding principles are to create a positive environment and to convey that the caregiver is the expert on their own child. The AVI methodology was selected to be used as a method of caregiving intervention with the study participants due to its demonstrated results in its use with children in contexts of social vulnerability, as well as families included in the child protection system. This will be the first time that AVI is being used in foster and institutional care in Brazil.
Treatment groups
Trial outcomes
Primary outcomes
Differences in security of attachment
Strange Situation Procedure
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity
EEG power
Secondary outcomes
Differences in Cognition in early Childhood
Mullen Scales of Early Learning, AGS Edition. For the subscales (Visual Receptions, Fine Motor, Gross Motor, Receptive, and Expressive Language), the minimum T-score is 20 and the maximum is 80. A higher score indicates a better outcome. The Composite Standard Score goes from 49 to 155; 155 is the best outcome.
Differences in Attachment Disturbances and Disorders
Disturbances of Attachment Interview
Differences in Competence
Infant Toddler Social Emotional Assessments- Revised. Range for competence is 0-66. Ratings are 0, 1, 2 on 33 items. Higher scores are better outcomes. T-scores of 35 or lower on the Competence scale are also termed "of concern."
Sponsors and contacts
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Boston Children's Hospital
Lead sponsor
University of Maryland, College Park
Collaborator
Tulane University
Collaborator
Instituto PENSI
Collaborator
Harvard University
Collaborator
Inter-American Development Bank
Collaborator
Lumos Foundation
Collaborator
Two Lilies Fund
Collaborator
Fundação Maria Cecilia Souto Vidigal
Collaborator