CClinicalTrials.gg
CompletedNCT03010306Updated Jan 16, 2017

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

An interventional study of CASITA in Child Developmental Delay, Child Development and Community Health Workers, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 6 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-16.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Non-randomized
Ages
6 Months to 24 Months
Sex
All
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Study 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.

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Conditions studied

  • Child Developmental Delay
  • Child Development
  • Community Health Workers
  • Low Income Population
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In context

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 24 Months
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • 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

Interventions

  • OtherCASITA

    Also known as: Child development coaching and social support in Lima Peru, Community-based intervention for children at risk of Neurodevelopment delay

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What researchers measure

Primary outcomes

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

    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.

    Time frame: baseline, 3 months

Secondary outcomes

  1. Change in global HOME score

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

    Time frame: baseline, 3 months

  2. Change in HOME subscore of parent responsivity

    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".

    Time frame: baseline, 3 months

  3. Change in HOME subscore of parent involvement

    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".

    Time frame: baseline, 3 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4. PubMed 17208643 ↗
  • Nahar B, Hamadani JD, Ahmed T, Tofail F, Rahman A, Huda SN, Grantham-McGregor SM. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009 Jun;63(6):725-31. doi: 10.1038/ejcn.2008.44. Epub 2008 Sep 3. PubMed 18772893 ↗
  • Nahar B, Hossain MI, Hamadani JD, Ahmed T, Huda SN, Grantham-McGregor SM, Persson LA. Effects of a community-based approach of food and psychosocial stimulation on growth and development of severely malnourished children in Bangladesh: a randomised trial. Eur J Clin Nutr. 2012 Jun;66(6):701-9. doi: 10.1038/ejcn.2012.13. Epub 2012 Feb 22. PubMed 22353925 ↗
  • Munoz M, Bayona J, Sanchez E, Arevalo J, Sebastian JL, Arteaga F, Guerra D, Zeladita J, Espiritu B, Wong M, Caldas A, Shin S. Matching social support to individual needs: a community-based intervention to improve HIV treatment adherence in a resource-poor setting. AIDS Behav. 2011 Oct;15(7):1454-64. doi: 10.1007/s10461-010-9697-9. PubMed 20383572 ↗
  • Caldwell, B. and R. Bradley, eds. Home Inventory Administration Manual. 3rd Edition ed. 2001, University of Arkansas at Little Rock: Little Rock, AR.
  • Schreiner, M., Progress out of Poverty Index: A Simple Poverty Score for Peru. 2008, Grameen Foundation: St Louis, MO.
  • Fernald LC, Kariger P, Hidrobo M, Gertler PJ. Socioeconomic gradients in child development in very young children: evidence from India, Indonesia, Peru, and Senegal. Proc Natl Acad Sci U S A. 2012 Oct 16;109 Suppl 2(Suppl 2):17273-80. doi: 10.1073/pnas.1121241109. Epub 2012 Oct 8. PubMed 23045688 ↗
  • Rodriquez, S., ed. Escala de evaluacion del desarollo psicomotor: 0 a 24 meses. 12th ed ed. 1996, Galdoc: Santiago, Chile.
  • Engle PL, Black MM, Behrman JR, Cabral de Mello M, Gertler PJ, Kapiriri L, Martorell R, Young ME; International Child Development Steering Group. Strategies to avoid the loss of developmental potential in more than 200 million children in the developing world. Lancet. 2007 Jan 20;369(9557):229-42. doi: 10.1016/S0140-6736(07)60112-3. PubMed 17240290 ↗
  • Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4. PubMed 27717632 ↗
  • Becares L, Nazroo J, Kelly Y. A longitudinal examination of maternal, family, and area-level experiences of racism on children's socioemotional development: Patterns and possible explanations. Soc Sci Med. 2015 Oct;142:128-35. doi: 10.1016/j.socscimed.2015.08.025. Epub 2015 Aug 15. PubMed 26301485 ↗
  • Hanson JL, Chandra A, Wolfe BL, Pollak SD. Association between income and the hippocampus. PLoS One. 2011 May 4;6(5):e18712. doi: 10.1371/journal.pone.0018712. PubMed 21573231 ↗
  • Luby J, Belden A, Botteron K, Marrus N, Harms MP, Babb C, Nishino T, Barch D. The effects of poverty on childhood brain development: the mediating effect of caregiving and stressful life events. JAMA Pediatr. 2013 Dec;167(12):1135-42. doi: 10.1001/jamapediatrics.2013.3139. PubMed 24165922 ↗
  • Garner AS. Home visiting and the biology of toxic stress: opportunities to address early childhood adversity. Pediatrics. 2013 Nov;132 Suppl 2:S65-73. doi: 10.1542/peds.2013-1021D. PubMed 24187125 ↗
  • Grantham-McGregor SM, Powell CA, Walker SP, Himes JH. Nutritional supplementation, psychosocial stimulation, and mental development of stunted children: the Jamaican Study. Lancet. 1991 Jul 6;338(8758):1-5. doi: 10.1016/0140-6736(91)90001-6. PubMed 1676083 ↗
  • Munoz M, Nelson A, Johnson M, Godoy N, Serrano E, Chagua E, Valdivia J, Santacruz J, Wong M, Kolevic L, Kammerer B, Vega C, Vibbert M, Lundy S, Shin S. Community-Based Needs Assessment of Neurodevelopment, Caregiver, and Home Environment Factors in Young Children Affected by HIV in Lima, Peru. J Int Assoc Provid AIDS Care. 2017 Mar/Apr;16(2):161-167. doi: 10.1177/2325957416631625. Epub 2016 Jul 8. PubMed 26917559 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03010306
Lead sponsor
Brigham and Women's Hospital
Collaborators
Grand Challenges Canada, Harvard University, Boston Children's Hospital, Boston Medical Center, Partners in Health
Responsible party
Adrianne Katrina Hart Nelson (Research Manager, Brigham and Women's Hospital) — Principal investigator
First posted
Jan 5, 2017
Start date
Sep 2013
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Jan 16, 2017

Study contacts

Leonid Lecca, MD
principal investigator · Socios En Salud, Peru

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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