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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03010306
Collaborator
Grand Challenges Canada (Other), Harvard University (Other), Boston Children's Hospital (Other), Boston Medical Center (Other), Partners in Health (Other)
61
Enrollment
2
Arms
25
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CASITA
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in risk of delay, as measured by the EASQ [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.

    Secondary Outcome Measures

    1. Change in global HOME score [baseline, 3 months]

      The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.

    2. Change in HOME subscore of parent responsivity [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".

    3. Change in HOME subscore of parent involvement [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".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • Grand Challenges Canada
    • Harvard University
    • Boston Children's Hospital
    • Boston Medical Center
    • Partners in Health

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Adrianne Katrina Hart Nelson, Research Manager, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT03010306
    Other Study ID Numbers:
    • 2013P002554
    First Posted:
    Jan 5, 2017
    Last Update Posted:
    Jan 16, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 16, 2017