Early Institutionalization Intervention Impact Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Foster Care, Caregiving Intervention.
- Who it may be relevant to
- Registry conditions: Socioemotional Development, Cognitive Ability, Behavioral and Neural Patterns of Attention, Brain Function. Basic parameters: up to 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Other Foster Care
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. Chi - Behavioral Caregiving Intervention
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
Primary outcome measures
- Differences in security of attachment [Time frame: baseline, 12 mos, 24 mos, 36 mos]
- Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity [Time frame: baseline, 12 mos, 24 mos, 36 mos]
Secondary outcome measures (3)
- Differences in Cognition in early Childhood [Time frame: baseline, 12 mos, 24 mos, 36 mos]
- Differences in Attachment Disturbances and Disorders [Time frame: baseline, 12 mos, 24 mos, 36 mos]
- Differences in Competence [Time frame: baseline, 12 mos, 24 mos, 36 mos]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Brazil · 1 center
- Instituto PENSI — São Paulo
Identifiers
NCT: NCT04165746 · IRB-P00026292