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

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ClinicalTrials.gov Identifier: NCT03010306
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : January 16, 2017
Sponsor:
Collaborators:
Grand Challenges Canada
Harvard University
Boston Children’s Hospital
Boston Medical Center
Partners in Health
Information provided by (Responsible Party):
Adrianne Katrina Hart Nelson, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE January 5, 2017
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03010306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • 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.
  • 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".
  • 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".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru
Official Title  ICMJE Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Child Developmental Delay
  • Child Development
  • Community Health Workers
  • Low Income Population
Intervention  ICMJE Other: CASITA
Other Names:
  • Child development coaching and social support in Lima Peru
  • Community-based intervention for children at risk of Neurodevelopment delay
Study Arms  ICMJE
  • 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.
    Intervention: Other: CASITA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
61
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03010306
Other Study ID Numbers  ICMJE 2013P002554
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adrianne Katrina Hart Nelson, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • Grand Challenges Canada
  • Harvard University
  • Boston Children’s Hospital
  • Boston Medical Center
  • Partners in Health
Investigators  ICMJE
Principal Investigator: Leonid Lecca, MD Socios En Salud, Peru
PRS Account Brigham and Women's Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP