Early Institutionalization Intervention Impact Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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 5-1.5 hour sessions over 6-8 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.

Official Title
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Early Institutionalization Intervention Impact Project

Conditions
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Socioemotional Development, Cognitive Ability, Behavioral and Neural Patterns of Attention, Brain Function, Psychopathology

Intervention / Treatment
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* Other: Foster Care
* Behavioral: Caregiving Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children will be randomized to either enhanced institutional care or enhanced foster care. Both arms of the RCT will participate in an intervention. Children randomized to foster care will receive 2 forms of intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Institutional Care<br>Caregivers at institutions will participate in a caregiving training, called Video Feedback Intervention to Promote Positive Parenting (VIPP). During VIPP a trained interventionist meets with a caregiver and child in the home environment. 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. | Behavioral: Caregiving Intervention<br>* 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.<br>* Other names: Attachment Video Feedback intervention;|
| Experimental: Enhanced Foster Care<br>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<br>* 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.<br>Behavioral: Caregiving Intervention<br>* 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.<br>* Other names: Attachment Video Feedback intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in security of attachment | Strange Situation Procedure | baseline, 12 mos, 24 mos, 36 mos | 
| Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity | EEG power | baseline, 12 mos, 24 mos, 36 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 12 mos, 24 mos, 36 mos | 
| Differences in Attachment Disturbances and Disorders | Disturbances of Attachment Interview | 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. | baseline, 12 mos, 24 mos, 36 mos | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brazil, children, foster care, institutionalization, attachment, brain function, language, growth, Intelligence Quotient (IQ), early intervention