Child Developmental DelayNCT03010306

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

A study testing CASITA in people with Child Developmental Delay and Child Development, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Child Developmental Delay, Child Development, Community Health Workers
What is being tested?: CASITA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: No sites listed yet
Study dates: Sep 2013to Oct 2015
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 6 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age between 6 - 24 months of age;
Known primary caregiver (parent or legal guardian) living with child;
Living within the catchment area of the 6 Health Centers that comprise the study zone.
Screen positive for neurodevelopment delay ("at risk" or "delayed" in neurodevelopment based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).
Be at risk by scoring <45 on the Progress Out of Poverty Index.

Who cannot join

A known medical condition that would make the child unresponsive to early intervention;
Family anticipates moving within the next three months.

About this study

Official title: Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru

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.

Conditions: Child Developmental Delay, Child Development, Community Health Workers, Low Income Population
Being tested: CASITA
Medical subject headings: Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03010306
Study group	Role	What they receive
Nutrition only	No intervention	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.
Nutrition + CASITA	Active comparator	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. Receives: Other: CASITA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, 3 months

Secondary outcomes (3)

Change in global HOME score
The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.
Measured: baseline, 3 months
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".
Measured: baseline, 3 months
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".
Measured: baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Oct 2015

First posted5 Jan 2017 (estimated)
Study startSep 2013
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Child Developmental DelayStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03010306
Sponsor's protocol ID: 2013P002554
Status last verified: Jan 2017
First submitted: 20 Dec 2016
Last updated: 16 Jan 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Child Developmental Delay trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru
ClinicalTrials.gov ID: NCT03010306
Acronym / sponsor ID: 2013P002554
Conditions: Child Developmental Delay, Child Development, Community Health Workers, Low Income Population
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Grand Challenges Canada, Harvard University, Boston Children's Hospital, Boston Medical Center, Partners in Health
Study start: Sep 2013
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 5 Jan 2017 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nutrition only	No intervention	–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.
Nutrition + CASITA	Active comparator	Other: CASITAThe 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.

Who may qualify

Ages: 6 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Age between 6 - 24 months of age;
Known primary caregiver (parent or legal guardian) living with child;
Living within the catchment area of the 6 Health Centers that comprise the study zone.
Screen positive for neurodevelopment delay ("at risk" or "delayed" in neurodevelopment based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).
Be at risk by scoring <45 on the Progress Out of Poverty Index.

Key exclusion criteria (2 listed)

A known medical condition that would make the child unresponsive to early intervention;
Family anticipates moving within the next three months.

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
CASITAAlso: Child development coaching and social support in Lima Peru, Community-based intervention for children at risk of Neurodevelopment delay	Other	Nutrition + CASITA

Primary outcome

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.

3 secondary outcomes

Change in global HOME score
Time frame: baseline, 3 months
Change in HOME subscore of parent responsivity
Time frame: baseline, 3 months
Change in HOME subscore of parent involvement
Time frame: baseline, 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
Background: PubMed 17208643Grantham-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.
Background: PubMed 18772893Nahar 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.
Background: PubMed 22353925Nahar 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.
Background: PubMed 20383572Munoz 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.
BackgroundCaldwell, B. and R. Bradley, eds. Home Inventory Administration Manual. 3rd Edition ed. 2001, University of Arkansas at Little Rock: Little Rock, AR.
BackgroundSchreiner, M., Progress out of Poverty Index: A Simple Poverty Score for Peru. 2008, Grameen Foundation: St Louis, MO.
Background: PubMed 23045688Fernald 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.
BackgroundRodriquez, S., ed. Escala de evaluacion del desarollo psicomotor: 0 a 24 meses. 12th ed ed. 1996, Galdoc: Santiago, Chile.
Background: PubMed 17240290Engle 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.
Background: PubMed 27717632Lu 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.
Background: PubMed 26301485Becares 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.
Background: PubMed 21573231Hanson 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.
CASITA scale-up: Saving Brains InnovationLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Leonid Lecca, MD principal investigator

Socios En Salud, Peru

Questions about this trial

What is this clinical trial studying?

A study testing CASITA in people with Child Developmental Delay and Child Development, run by Brigham and Women's Hospital.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in risk of delay, as measured by the EASQ (time frame: baseline, 3 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 NCT03010306, which also lists 16 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 16 Jan 2017.