Clinical trial NCT04165746: Early Institutionalization Intervention Impact Project
Official title: Early Institutionalization Intervention Impact Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Socioemotional Development
Cognitive Ability
Behavioral and Neural Patterns of Attention
Brain Function
Psychopathology
Keywords: Brazil
children
foster care
institutionalization
attachment
brain function
language
growth
Intelligence Quotient (IQ)
early intervention
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
name: Tulane University
name: Instituto PENSI
name: Harvard University
name: Inter-American Development Bank
name: Lumos Foundation
name: Two Lilies Fund
name: Fundaçao Maria Cecilia Souto Vidigal
First posted: 2019-11-18
Enrollment: 220
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Primary outcomes:
measure: Differences in security of attachment
timeFrame: baseline, 12 mos, 24 mos, 36 mos
measure: Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity
timeFrame: baseline, 12 mos, 24 mos, 36 mos
Secondary outcomes:
measure: Differences in Cognition in early Childhood
timeFrame: baseline, 12 mos, 24 mos, 36 mos
measure: Differences in Attachment Disturbances and Disorders
timeFrame: baseline, 12 mos, 24 mos, 36 mos
measure: Differences in Competence
timeFrame: baseline, 12 mos, 24 mos, 36 mos
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto PENSI
Study officials:
affiliation: University of Maryland
name: Nathan A Fox, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BOSTON CHILDRENS HOSPITAL/ Harvard University
name: Charles A Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University School of Medicine
name: Charles H Zeanah, PhD
role: PRINCIPAL_INVESTIGATOR
References: