An interventional study of Foster Care and Caregiving Intervention in Socioemotional Development, Cognitive Ability and Behavioral and Neural Patterns of Attention, sponsored by Boston Children's Hospital. Recruiting at 1 site in Brazil. Open to participants aged Up to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Basic science
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.
The Early Institutionalization Intervention Impact (EI-3) Project will document and compare the impact of enhanced institutional care on early childhood development to that of high-quality foster care. We will recruit a large (n= 220) samples of young children who have been identified as having to be removed from their families and we will randomize these children to two groups: enhanced institutional care (Group 1) or to enhanced foster care (Group 2). Institutional caregivers and Foster Parents will participate in a caregiving training, along with the child, that includes 8-1.5 hour sessions over 8-9 weeks.
In this Randomized Control Trial (RCT), we will assess the children in Groups 1 and 2 at the time they come into care and then at several follow-up time points (12 months, 24 months, 36 months of age). We hypothesize that children placed into foster/family care (FCG) will display enhanced socioemotional development, and enhanced behavioral and neural patterns of attention, cognition and social cognition, compared to children placed in enhanced institutional care.
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This study's planned enrollment of 220 is above the median of 120 across 1,197 interventional studies indexed under Behavior.
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Exclusion Criteria:
Caregivers at institutions will participate in a caregiving training, called Attachment VideoFeedback Intervention (AVI). During AVI a trained interventionist meets with a caregiver and child in the home environment. The AVI Interventionist will meet with caregivers and children for 8, 1.5-hours sessions over 8-9 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.
Behavioral: Caregiving Intervention
Foster parents will be recruited, consented to background checks, and trained in Portuguese. Hired foster parents will supported and monitored by project social workers and psychologists from local Foster Care programs. Foster parents will received frequent visits from the social workers, with visits occurring weekly for several months after placement of the child, then biweekly and later monthly. Project social workers will consult weekly with US staff experienced in dealing with young children in foster care. Additionally, foster parents will participate in the VIPP caregiving training, in the same format as that described in the Enhanced Institutional Care Arm: the VIPP Interventionist will meet with caregivers and children for 5, 2-hours sessions over 6-8 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.
Other: Foster Care · Behavioral: Caregiving Intervention
Upon 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.
During 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.
Also known as: Attachment Video Feedback intervention
Differences in security of attachment
Strange Situation Procedure
Time frame: baseline, 12 mos, 24 mos, 36 mos
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity
EEG power
Time frame: baseline, 12 mos, 24 mos, 36 mos
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.
Time frame: baseline, 12 mos, 24 mos, 36 mos
Differences in Attachment Disturbances and Disorders
Disturbances of Attachment Interview
Time frame: baseline, 12 mos, 24 mos, 36 mos
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."
Time frame: baseline, 12 mos, 24 mos, 36 mos
Plan to share: No
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