CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru

January 12, 2017 updated by: Adrianne Katrina Hart Nelson, Brigham and Women's Hospital

Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru

Building on an intervention for early child development from the SPARK Center in Boston, Socios En Salud (SES) pilot tested "CASITA" a community-based package to screen and treat young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays within the clinics and community and delivered a structured early intervention that included parent coaching and social support. In order to test the hypothesis that CASITA improves early child development, caregiver, and home environment, dyads received either nutrition supplements alone, nutrition + "CASITA" early child development sessions individually, or CASITA in a group of 10 dyads.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 6 - 24 months of age;
  2. Known primary caregiver (parent or legal guardian) living with child;
  3. Living within the catchment area of the 6 Health Centers that comprise the study zone.
  4. Screen positive for neurodevelopment delay ("at risk" or "delayed" in neurodevelopment based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).
  5. Be at risk by scoring <45 on the Progress Out of Poverty Index.

Exclusion Criteria:

  1. A known medical condition that would make the child unresponsive to early intervention;
  2. Family anticipates moving within the next three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Nutrition only
Monthly food baskets were provided to the nutrition only group. Food baskets included basic foods to sustain a family of three over one month's time, such as rice and evaporated milk. Food baskets were valued at approximately $28 US Dollars per basket.
Active Comparator: Nutrition + CASITA
The CASITA intervention was given by a community health worker (CHW) and involves individual and group modalities. HOME-CASITA took place at the dyad's place of residence, and the GROUP-CASITA at a local community center. All CASITA participants received 12 weekly sessions over 3 months. Interventions retain core elements of the SPARK approach: coaching parents on child development stimulation and providing social support and encouragement. Each session is as follows: 1) Child observation & knowledge sharing about child development; 2) Practice of reciprocal attention focusing and social interaction activities; 3) Parent encouragement on behavior and developmental interactions; and 4) Parent social support through referral assistance, reassurance, and validation of parent's concerns.
Other: CASITA
Other Names:
  • Child development coaching and social support in Lima Peru
  • Community-based intervention for children at risk of Neurodevelopment delay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in risk of delay, as measured by the EASQ
Time Frame: baseline, 3 months
The Ages and Stages Questionnaire (ASQ) is an internationally-validated instrument that can be used to assess change in developmental risk over time. Fernald et al incorporated additional observation-based assessments and the following modifications: 1) addition of child observation exercises to allow for validity check of parent responses (original ASQ questions), and 2) the incorporation of ASQ questions from the next highest age range. The Extended Ages and Stages Questionnaire (EASQ) was utilized as an assessment tool to allow us to better quantify degree of risk at baseline (based on quintiles of scores). By incorporating ASQ questions from the next two highest age ranges, scores will be continuous across the study period of three. The EASQ has been applied to children in four countries, including 2,845 children in Peru.
baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global HOME score
Time Frame: baseline, 3 months
The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.
baseline, 3 months
Change in HOME subscore of parent responsivity
Time Frame: baseline, 3 months
This HOME subscore is defined in the manual as "the extent to which the parent responds to the child's behavior including reinforcement for desired behavior and communication through words and actions".
baseline, 3 months
Change in HOME subscore of parent involvement
Time Frame: baseline, 3 months
This HOME subscore is defined as "parental acceptance of the child's behavior that is less than optimal and examines avoidance of undue restriction and punishment".
baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Boston Children's Hospital
Boston Medical Center
Grand Challenges Canada
Harvard University
Partners in Health

Investigators

  • Principal Investigator: Leonid Lecca, MD, Socios En Salud, Peru

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2013P002554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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