Child DevelopmentNPECDP-UKANCT04210362
External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda
A study testing Workshops on responsive caregiving in people with Child Development, run by Amado David Quezada Sánchez at 1 site in Mexico.
Trial summary
Investing in early childhood development is one of the best cost-effective investments a country can make to boost long term economic growth, promote peaceful and sustainable societies, contribute to tackle poverty traps and eradicate inequality. Read more about this study
- Who is it for?
- Ages 1 month to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Workshops on responsive caregiving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jul 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Communities: Municipalities in the State of Oaxaca where the NPECDP-UKA is not currently operating.
- Whithin selected communities:
- children aged1 to 60 months and their caregivers who decided to enroll in the NPECDP-UKA.
Who cannot join
- Communities: Municipalities in the State of Oaxaca with a population of children under 5 years of age below 35 habitants according to the Census of 2010
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican Non-governmental Organization Un Kilo de Ayuda
Investing in early childhood development is one of the best cost-effective investments a country can make to boost long term economic growth, promote peaceful and sustainable societies, contribute to tackle poverty traps and eradicate inequality. It is also necessary to uphold the right of every child to survive and thrive. The single most powerful context for nurturing care is the immediate home, often mainly provided by mothers.
Although the Mexican government has implemented social programs in the past, some with nutrition and child development components, poor and isolated communities have not benefited as others easier to reach. This is particularly true for the State of Oaxaca given its orography, where higher levels of malnutrition and a higher risk of suboptimal neurodevelopment are present.
Read more
Since 1989, Un Kilo de Ayuda A.C. (UKA), a nongovernmental organization, has been involved in preventing child undernutrition in contexts of high poverty. Currently, UKA has 9 Early Childhood Development Centers distributed in 5 States of Mexico, including Oaxaca. UKA has developed the Neurological and Psycho-affective Early Childhood Development Program (NPECDP-UKA) that seeks to contribute to timely stimulation in children under 5 years of age and promote perceptual parenting practices. As part of the NPECDP-UKA, UKA redesigned their interventions to promote healthy nurturing care practices and responsive caregiving through workshops provided to caregivers and pregnant women, and with reinforcement through home visits.
It is in the interest of this study to evaluate the NPECDP-UKA through a variation of a stepped wedge cluster randomized trial. The study sample consists of participants from 80 municipalities of Oaxaca (~50% with high or very high margination status), 20 municipalities were randomly assigned to each arm. Study arms differ by design on the time of exposure to the program (0,18,24 and 30 months at the final measurement). Subjects from all study groups share the characteristic to be enrolled in the NPECDP-UKA, the group with 0 months of exposure will serve as a comparison group. This distinctive characteristic of the study requires a progressive incorporation of study groups to be able to compare development measurements between study groups at the same ages and among subjects all enrolled in the program to avoid self-selection bias. The main study hypothesis states that children exposed to the Program will have better neurodevelopment outcomes than those not exposed.
This study will provide evidence of the effect of an educational intervention for caregivers on the neurodevelopment of children under 5 years of age. Currently evidence of such interventions is very limited, especially for interventions performed by a nongovernmental organization. This is the first evaluation of this kind in Mexico.
- Conditions
- Child Development
- Being tested
- Workshops on responsive caregiving
- Keywords
- neurodevelopment, responsive caregiving, nuturing care, counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workshops on responsive caregivingBehavioural
Caregivers will receive monthly workshops about several dimensions of nurturing care, responsive caregiving and early child development. Workshops will be reinforced through home visits.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention for 30 months | Experimental | Children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 30 months. Receives: Behavioral: Workshops on responsive caregiving |
| Educational intervention for 24 months | Experimental | Children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 24 months. Receives: Behavioral: Workshops on responsive caregiving |
| Educational intervention for 12 months | Experimental | Children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 12 months. Receives: Behavioral: Workshops on responsive caregiving |
| Comparison group | No intervention | Group comprised of children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca, Mexico. Children and their caregivers will not be exposed to the intervention at the moment of their measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Development Evaluation Test 2nd Edition (CDE-II)
The CDE-II, or Evaluación del Desarrollo Infantil (EDI-II) in Spanish, was developed and validated in Mexico to screen populations for lag and for risk of delay in child development. The test has specific items for 14 age groups of children aged 1 to 60 months. Assessed developmental areas include gross motor skills, fine motor skills, language, social skills, and cognitive skills. The CDE-II is based on age-group specific items, score results are categorized into three levels: Green (normal development), Yellow (developmental lag) and Red (at risk of development delay)
Measured: Up to 30 months
Secondary outcomes (6)
Verbal McCarthy Scale of Children's Abilities (MSCA)
The verbal MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Measured: Up to 30 months
Perceptual-performance McCarthy Scale of Children's Abilities (MSCA)
The perceptual-performance MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Measured: Up to 30 months
Quantitative McCarthy Scale of Children's Abilities (MSCA)
The quantitative MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Measured: Up to 30 months
Memory McCarthy Scale of Children's Abilities (MSCA)
The memory MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Measured: Up to 30 months
Motor McCarthy Scale of Children's Abilities (MSCA)
The motor MSCA has an arbitrarily chosen mean of 50 and stadard deviation of 10. Higher values indicate a higher level of the measured dimension.
Measured: Up to 30 months
General Cognitive Index from McCarthy Scales of Children's Abilities (MSCA)
The General Cognitive Scale is obtained adding up the verbal, percetual-performance and quantitative MSCA and it is converted into the General Cognitive Index (GCI). The GCI has a mean set at 100 and a standard deviation of 16.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start15 Jul 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Why it stopped: Due to the Covid-19 contingency, activities were suspended in March 2020. Baseline measurements were obtained for n=764 children whose caregivers enrolled in the NPECDP-UKA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A variation of the stepped wedge cluster randomized trial design was specified. Due to ethical and logistical considerations, the intervention in study groups under this design starts sequentially but measurements are performed at the same time period in all groups. The key difference between groups is thus the time of exposure to the intervention. Clusters were randomized into four study groups (30, 24, and 12 months of exposure, and a non-exposed group). The intervention consists of educational workshops for caregivers aimed at promoting healthy nurturing care practices and responsive caregiving. Assessment of intervention effects is performed as in a parallel design.
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amado David Quezada Sánchez
- Sponsor type
- Other government
- Collaborators
- Un Kilo de Ayuda A.C., Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Responsible party
- Sponsor-investigator, Amado David Quezada Sánchez, Mexican National Institute of Public Health
- Investigators
- Edson Serván-Mori, PhD, Principal investigator, Mexican National Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210362
- Sponsor's protocol ID
- 1538/CI-896-2018/CB18-317
- Acronym
- NPECDP-UKA
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2019
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van der Gaag J, Tan J-P. The benefits of early child development programs: an economic analysis. World Bank Group; 1998
Heckman JJ, Moon SH, Pinto R, Savelyev P, Yavitz A. A new cost-benefit and rate of return analysis for the Perry Preschool Program: A summary. Cambridge, MA 02138: National Bureau of Economic Research; 2010. (NBER Working Paper). Report No.: 16180
Heckman J, Carneiro P. Human capital policy. Cambridge, MA 02138: National Bureau of Economic Research; 2003. (NBER Working Paper). Report No.: 9495
Delalibera BR, Ferreira PC. Early childhood education and economic growth. J Econ Dyn Control. 2019;98:82-104
Organization WH, Fund UNC, Group WB. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. Ginebra 27, Suiza: World Health Organization; 2018
Bick J, Nelson CA. Early Adverse Experiences and the Developing Brain. Neuropsychopharmacology. 2016 Jan;41(1):177-96. doi: 10.1038/npp.2015.252. Epub 2015 Sep 3.
PubMed 26334107Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.
PubMed 22201156Force LMT. Toward Universal Learning: What Every Child Should Learn. Washington/Montreal: Brookings/UIS. 2013
Child C on the D. The Science of Early Childhood Development Closing the Gap Between What We Know and What We Do [Internet]. Cambridge, MA 02138; 2007. Available from: https://developingchild.harvard.edu/wp-content/uploads/2015/05/Science_Early_Childhood_Development.pdf
Duncan GJ, Dowsett CJ, Claessens A, Magnuson K, Huston AC, Klebanov P, Pagani LS, Feinstein L, Engel M, Brooks-Gunn J, Sexton H, Duckworth K, Japel C. School readiness and later achievement. Dev Psychol. 2007 Nov;43(6):1428-1446. doi: 10.1037/0012-1649.43.6.1428.
PubMed 18020822Blair C, Razza RP. Relating effortful control, executive function, and false belief understanding to emerging math and literacy ability in kindergarten. Child Dev. 2007 Mar-Apr;78(2):647-63. doi: 10.1111/j.1467-8624.2007.01019.x.
PubMed 17381795Shonkoff JP, Boyce WT, McEwen BS. Neuroscience, molecular biology, and the childhood roots of health disparities: building a new framework for health promotion and disease prevention. JAMA. 2009 Jun 3;301(21):2252-9. doi: 10.1001/jama.2009.754.
PubMed 19491187Caspi A, Moffitt TE, Newman DL, Silva PA. Behavioral observations at age 3 years predict adult psychiatric disorders. Longitudinal evidence from a birth cohort. Arch Gen Psychiatry. 1996 Nov;53(11):1033-9. doi: 10.1001/archpsyc.1996.01830110071009.
PubMed 8911226Heckman JJ. Skill formation and the economics of investing in disadvantaged children. Science. 2006 Jun 30;312(5782):1900-2. doi: 10.1126/science.1128898.
PubMed 16809525Young ME. Addressing and mitigating vulnerability across the life cycle: The case for investing in early childhood. UNDP Hum Dev Rep Off. 2014
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican Non-governmental Organization Un Kilo de Ayuda
- ClinicalTrials.gov ID
- NCT04210362
- Acronym / sponsor ID
- NPECDP-UKA / 1538/CI-896-2018/CB18-317
- Conditions
- Child Development
- Keywords
- neurodevelopment, responsive caregiving, nuturing care, counseling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the Covid-19 contingency, activities were suspended in March 2020. Baseline measurements were obtained for n=764 children whose caregivers enrolled in the NPECDP-UKA.
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Amado David Quezada SánchezOther government
- Collaborators
- Un Kilo de Ayuda A.C., Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investing in early childhood development is one of the best cost-effective investments a country can make to boost long term economic growth, promote peaceful and sustainable societies, contribute to tackle poverty traps and eradicate inequality. It is also necessary to uphold the right of every child to survive and thrive. The single most powerful context for nurturing care is the immediate home, often mainly provided by mothers.
Although the Mexican government has implemented social programs in the past, some with nutrition and child development components, poor and isolated communities have not benefited as others easier to reach. This is particularly true for the State of Oaxaca given its orography, where higher levels of malnutrition and a higher risk of suboptimal neurodevelopment are present.
Since 1989, Un Kilo de Ayuda A.C. (UKA), a nongovernmental organization, has been involved in preventing child undernutrition in contexts of high poverty. Currently, UKA has 9 Early Childhood Development Centers distributed in 5 States of Mexico, including Oaxaca. UKA has developed the Neurological and Psycho-affective Early Childhood Development Program (NPECDP-UKA) that seeks to contribute to timely stimulation in children under 5 years of age and promote perceptual parenting practices. As part of the NPECDP-UKA, UKA redesigned their interventions to promote healthy nurturing care practices and responsive caregiving through workshops provided to caregivers and pregnant women, and with reinforcement through home visits.
It is in the interest of this study to evaluate the NPECDP-UKA through a variation of a stepped wedge cluster randomized trial. The study sample consists of participants from 80 municipalities of Oaxaca (~50% with high or very high margination status), 20 municipalities were randomly assigned to each arm. Study arms differ by design on the time of exposure to the program (0,18,24 and 30 months at the final measurement). Subjects from all study groups share the characteristic to be enrolled in the NPECDP-UKA, the group with 0 months of exposure will serve as a comparison group. This distinctive characteristic of the study requires a progressive incorporation of study groups to be able to compare development measurements between study groups at the same ages and among subjects all enrolled in the program to avoid self-selection bias. The main study hypothesis states that children exposed to the Program will have better neurodevelopment outcomes than those not exposed.
This study will provide evidence of the effect of an educational intervention for caregivers on the neurodevelopment of children under 5 years of age. Currently evidence of such interventions is very limited, especially for interventions performed by a nongovernmental organization. This is the first evaluation of this kind in Mexico.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A variation of the stepped wedge cluster randomized trial design was specified. Due to ethical and logistical considerations, the intervention in study groups under this design starts sequentially but measurements are performed at the same time period in all groups. The key difference between groups is thus the time of exposure to the intervention. Clusters were randomized into four study groups (30, 24, and 12 months of exposure, and a non-exposed group). The intervention consists of educational workshops for caregivers aimed at promoting healthy nurturing care practices and responsive caregiving. Assessment of intervention effects is performed as in a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Educational intervention for 30 months | Experimental | Behavioral: Workshops on responsive caregivingChildren aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 30 months. |
| Educational intervention for 24 months | Experimental | Behavioral: Workshops on responsive caregivingChildren aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 24 months. |
| Educational intervention for 12 months | Experimental | Behavioral: Workshops on responsive caregivingChildren aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca will have been exposed to the Neurobehavioral and Psycho-affective Development Program for 12 months. |
| Comparison group | No intervention | –Group comprised of children aged 31 to 60 months and their caregivers from 20 municipalities of Oaxaca, Mexico. Children and their caregivers will not be exposed to the intervention at the moment of their measurements. |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Communities: Municipalities in the State of Oaxaca where the NPECDP-UKA is not currently operating.
- Whithin selected communities:
- children aged1 to 60 months and their caregivers who decided to enroll in the NPECDP-UKA.
Key exclusion criteria (1 listed)
- Communities: Municipalities in the State of Oaxaca with a population of children under 5 years of age below 35 habitants according to the Census of 2010
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workshops on responsive caregivingCaregivers will receive monthly workshops about several dimensions of nurturing care, responsive caregiving and early child development. Workshops will be reinforced through home visits. | Behavioural | Educational intervention for 12 months, Educational intervention for 24 months, Educational intervention for 30 months |
Primary outcome
Child Development Evaluation Test 2nd Edition (CDE-II)
Time frame: Up to 30 months
The CDE-II, or Evaluación del Desarrollo Infantil (EDI-II) in Spanish, was developed and validated in Mexico to screen populations for lag and for risk of delay in child development. The test has specific items for 14 age groups of children aged 1 to 60 months. Assessed developmental areas include gross motor skills, fine motor skills, language, social skills, and cognitive skills. The CDE-II is based on age-group specific items, score results are categorized into three levels: Green (normal development), Yellow (developmental lag) and Red (at risk of development delay)
6 secondary outcomes
Verbal McCarthy Scale of Children's Abilities (MSCA)
Time frame: Up to 30 months
Perceptual-performance McCarthy Scale of Children's Abilities (MSCA)
Time frame: Up to 30 months
Quantitative McCarthy Scale of Children's Abilities (MSCA)
Time frame: Up to 30 months
Memory McCarthy Scale of Children's Abilities (MSCA)
Time frame: Up to 30 months
Motor McCarthy Scale of Children's Abilities (MSCA)
Time frame: Up to 30 months
General Cognitive Index from McCarthy Scales of Children's Abilities (MSCA)
Time frame: Up to 30 months
Results and safety
The study was stopped early (reason given: Due to the Covid-19 contingency, activities were suspended in March 2020. Baseline measurements were obtained for n=764 children whose caregivers enrolled in the NPECDP-UKA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- BackgroundVan der Gaag J, Tan J-P. The benefits of early child development programs: an economic analysis. World Bank Group; 1998
- BackgroundHeckman JJ, Moon SH, Pinto R, Savelyev P, Yavitz A. A new cost-benefit and rate of return analysis for the Perry Preschool Program: A summary. Cambridge, MA 02138: National Bureau of Economic Research; 2010. (NBER Working Paper). Report No.: 16180
- BackgroundHeckman J, Carneiro P. Human capital policy. Cambridge, MA 02138: National Bureau of Economic Research; 2003. (NBER Working Paper). Report No.: 9495
- BackgroundDelalibera BR, Ferreira PC. Early childhood education and economic growth. J Econ Dyn Control. 2019;98:82-104
- BackgroundOrganization WH, Fund UNC, Group WB. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. Ginebra 27, Suiza: World Health Organization; 2018
- Background: PubMed 26334107Bick J, Nelson CA. Early Adverse Experiences and the Developing Brain. Neuropsychopharmacology. 2016 Jan;41(1):177-96. doi: 10.1038/npp.2015.252. Epub 2015 Sep 3.
- Background: PubMed 22201156Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.
- BackgroundForce LMT. Toward Universal Learning: What Every Child Should Learn. Washington/Montreal: Brookings/UIS. 2013
- BackgroundChild C on the D. The Science of Early Childhood Development Closing the Gap Between What We Know and What We Do [Internet]. Cambridge, MA 02138; 2007. Available from: https://developingchild.harvard.edu/wp-content/uploads/2015/05/Science_Early_Childhood_Development.pdf
- Background: PubMed 18020822Duncan GJ, Dowsett CJ, Claessens A, Magnuson K, Huston AC, Klebanov P, Pagani LS, Feinstein L, Engel M, Brooks-Gunn J, Sexton H, Duckworth K, Japel C. School readiness and later achievement. Dev Psychol. 2007 Nov;43(6):1428-1446. doi: 10.1037/0012-1649.43.6.1428.
- Background: PubMed 17381795Blair C, Razza RP. Relating effortful control, executive function, and false belief understanding to emerging math and literacy ability in kindergarten. Child Dev. 2007 Mar-Apr;78(2):647-63. doi: 10.1111/j.1467-8624.2007.01019.x.
- Background: PubMed 19491187Shonkoff JP, Boyce WT, McEwen BS. Neuroscience, molecular biology, and the childhood roots of health disparities: building a new framework for health promotion and disease prevention. JAMA. 2009 Jun 3;301(21):2252-9. doi: 10.1001/jama.2009.754.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edson Serván-Mori, PhD principal investigator
Mexican National Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workshops on responsive caregiving in people with Child Development, run by Amado David Quezada Sánchez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the Covid-19 contingency, activities were suspended in March 2020. Baseline measurements were obtained for n=764 children whose caregivers enrolled in the NPECDP-UKA.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Development Evaluation Test 2nd Edition (CDE-II) (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210362, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.