Socioemotional DevelopmentEI-3NCT04165746
Early Institutionalization Intervention Impact Project
A study testing Foster Care and Caregiving Intervention in people with Socioemotional Development and Cognitive Ability, run by Boston Children's Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Socioemotional Development, Cognitive Ability, Behavioral and Neural Patterns of Attention
- What is being tested?
- Foster Care and Caregiving Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Mar 2023to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto PENSI
São Paulo, São Paulo, 01228-200
Edson Amaro, MD, PhD, +55 11 2155-9358, edson.amaro@gmail.com
Edson Amaro, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Socioemotional Development, Cognitive Ability, Behavioral and Neural Patterns of Attention, Brain Function, Psychopathology
- Being tested
- Foster Care, Caregiving Intervention
- Keywords
- Brazil, children, foster care, institutionalization, attachment, brain function, language, growth, Intelligence Quotient (IQ), early intervention
- Medical subject headings
- Behavior, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foster CareOther
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 InterventionBehavioural
Also called Attachment Video Feedback 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Foster Care; Behavioral: Caregiving Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in security of attachment
Strange Situation Procedure
Measured: baseline, 12 mos, 24 mos, 36 mos
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity
EEG power
Measured: baseline, 12 mos, 24 mos, 36 mos
Secondary outcomes (3)
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.
Measured: baseline, 12 mos, 24 mos, 36 mos
Differences in Attachment Disturbances and Disorders
Disturbances of Attachment Interview
Measured: baseline, 12 mos, 24 mos, 36 mos
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."
Measured: baseline, 12 mos, 24 mos, 36 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start16 Mar 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socioemotional DevelopmentStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park, Tulane University, Instituto PENSI, Harvard University, Inter-American Development Bank, Lumos Foundation, Two Lilies Fund, Fundação Maria Cecilia Souto Vidigal
- Responsible party
- Principal investigator, Charles Alexander Nelson III, Boston Children's Hospital
- Investigators
- Nathan A Fox, PhD, Principal investigator, University of MarylandCharles A Nelson, PhD, Principal investigator, BOSTON CHILDRENS HOSPITAL/ Harvard UniversityCharles H Zeanah, PhD, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165746
- Sponsor's protocol ID
- IRB-P00026292
- Acronym
- EI-3
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Institutionalization Intervention Impact Project
- ClinicalTrials.gov ID
- NCT04165746
- Acronym / sponsor ID
- EI-3 / IRB-P00026292
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- University of Maryland, College Park, Tulane University, Instituto PENSI, Harvard University, Inter-American Development Bank, Lumos Foundation, Two Lilies Fund, Fundação Maria Cecilia Souto Vidigal
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Institutional Care | Experimental | Behavioral: Caregiving InterventionCaregivers 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. |
| Enhanced Foster Care | Experimental | Other: Foster Care, Behavioral: Caregiving InterventionFoster 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foster CareUpon 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. | Other | Enhanced Foster Care |
| Caregiving InterventionAlso: Attachment Video Feedback interventionDuring 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. | Behavioural | Enhanced Foster Care, Enhanced Institutional Care |
Primary outcome
Differences in security of attachment
Time frame: baseline, 12 mos, 24 mos, 36 mos
Strange Situation Procedure
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity
Time frame: baseline, 12 mos, 24 mos, 36 mos
EEG power
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan A Fox, PhD principal investigator
University of Maryland
Charles A Nelson, PhD principal investigator
BOSTON CHILDRENS HOSPITAL/ Harvard University
Charles H Zeanah, PhD principal investigator
Tulane University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foster Care and Caregiving Intervention in people with Socioemotional Development and Cognitive Ability, run by Boston Children's Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles A Nelson, PhD (617-355-0401, charles.nelson@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in security of attachment (time frame: baseline, 12 mos, 24 mos, 36 mos). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.