Early Institutionalization Intervention Impact Project

NCT04165746 | Recruiting DMC

• 1 other identifier: IRB-P00026292
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Brazil; children; foster care; institutionalization; attachment; brain function; language; growth; Intelligence Quotient (IQ); early intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Differences in Cognition in early Childhood

  baseline, 12 mos, 24 mos, 36 mos

• Differences in Attachment Disturbances and Disorders

  baseline, 12 mos, 24 mos, 36 mos

• Differences in Competence

  baseline, 12 mos, 24 mos, 36 mos

Study Arms (2)

Enhanced Institutional Care

EXPERIMENTAL

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

Enhanced Foster Care

EXPERIMENTAL

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

Interventions

Foster Care OTHER

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.

Enhanced Foster Care

Caregiving Intervention BEHAVIORAL

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

Enhanced Foster Care; Enhanced Institutional Care

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Instituto PENSI

São Paulo, São Paulo, 01228-200, Brazil

RECRUITING

MeSH Terms

Conditions

Behavior; Language

Interventions

Foster Home Care

Condition Hierarchy (Ancestors)

Communication

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nathan A Fox, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Charles A Nelson, PhD

  BOSTON CHILDRENS HOSPITAL/ Harvard University

  PRINCIPAL INVESTIGATOR

• Charles H Zeanah, PhD

  Tulane University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles A Nelson, PhD

CONTACT

617-355-0401; charles.nelson@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: March 16, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)