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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 June 2021 |
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Main ID: |
NCT03502252 |
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Date of registration:
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10/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Experimental Evaluation of Semillas de Apego
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Scientific title:
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Experimental Evaluation of Semillas de Apego, a Group-based Program to Foster Maternal Mental Health and Early Childhood Development Among Violence Exposed Communities in Colombia. |
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Date of first enrolment:
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March 5, 2018 |
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Target sample size:
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1280 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03502252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Andres Moya, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de los Andes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
The experimental evaluation of Semillas de Apego will be conducted as a Cluster-Randomized
Control Trial (C-RCT). The eligible population for the study are all families served by
Genesis Foundation's Early Childhood Development Center (ECDC) in Tumaco, Colombia and
whose children's ages range between 2 to 4 years of age. For example, for the first cohort,
the children should have been born between August 1st, 2014 to April 1st, 2016
Exclusion Criteria:
None
Age minimum:
2 Years
Age maximum:
4 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Attachment Disorder
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Child Development
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Exposure to Violent Event
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Parenting
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Intervention(s)
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Behavioral: Semillas de Apego
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Primary Outcome(s)
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Healthy child-parent emotional bonds
[Time Frame: 1 month after the end of intervention]
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Children's mental health
[Time Frame: 12 months after the end of the intervention]
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Healthy child-parent emotional bonds
[Time Frame: 12 months after the end of the intervention]
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Primary caregiver's mental health
[Time Frame: 1 month after the end of intervention]
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Child rearing practices
[Time Frame: 1 month after the end of intervention]
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Children's cognitive, social, and emotional development
[Time Frame: 12 months after the end of the intervention]
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Secondary Outcome(s)
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Children's social, and emotional development.
[Time Frame: 1 month after end of the intervention]
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Children's mental health:
[Time Frame: 1 month after end of the intervention]
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Secondary ID(s)
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UANDES835
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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