Early Institutionalization Intervention Impact Project

Psychopathology Clinical Trial

— EI-3  

Official title:

Early Institutionalization Intervention Impact Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04165746
• Other study ID #: IRB-P00026292
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: Boston Children's Hospital
• Contact: Charles A Nelson, PhD
• Phone: 617-355-0401
• Email: charles.nelson[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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. 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.

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 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.

Locations

Country	Name	City	State
Brazil	Instituto PENSI	São Paulo

Sponsors (9)

Lead Sponsor	Collaborator
Boston Children's Hospital	Fundaçao Maria Cecilia Souto Vidigal, Harvard University, Instituto PENSI, Inter-American Development Bank, Lumos Foundation, Tulane University, Two Lilies Fund, University of Maryland, College Park

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in security of attachment	Strange Situation Procedure	baseline, 12 mos, 24 mos, 36 mos
Primary	Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity	EEG power	baseline, 12 mos, 24 mos, 36 mos
Secondary	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
Secondary	Differences in Attachment Disturbances and Disorders	Disturbances of Attachment Interview	baseline, 12 mos, 24 mos, 36 mos
Secondary	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