Early Institutionalization Intervention Impact Project

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foster Care

    Other intervention

    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.

  • 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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Enhanced Institutional CareExperimental treatment 1 intervention
Group B: Enhanced Foster CareExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Differences in security of attachment

Strange Situation Procedure

Time frame
baseline, 12 mos, 24 mos, 36 mos
2

Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity

EEG power

Time frame
baseline, 12 mos, 24 mos, 36 mos

Secondary outcomes

1

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.

Time frame
baseline, 12 mos, 24 mos, 36 mos
2

Differences in Attachment Disturbances and Disorders

Disturbances of Attachment Interview

Time frame
baseline, 12 mos, 24 mos, 36 mos
3

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."

Time frame
baseline, 12 mos, 24 mos, 36 mos

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

University of Maryland, College Park

Collaborator

Tulane University

Collaborator

Instituto PENSI

Collaborator

Harvard University

Collaborator

Inter-American Development Bank

Collaborator

Lumos Foundation

Collaborator

Two Lilies Fund

Collaborator

Fundação Maria Cecilia Souto Vidigal

Collaborator