Early Child Development and GrowthPhase 2/3PEDSNCT00715936
The Pakistan Early Childhood Development Scale Up Trial
A Phase 2/3 study testing ECD and Enhanced Nutrition in people with Early Child Development and Growth, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living… Read more about this study
- Who is it for?
- Ages 1 day to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Child Development and Growth
- What is being tested?
- ECD and Enhanced Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,489 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2009to Mar 2012
- Phase
- Phase 2/3
- 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 day to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children born in the defined geographical area of study during the study enrollment period will be eligible for the study along with their primary care giver (mother). Infant must be 1d-2.5m of age at time of enrolment.
Who cannot join
- Children born with profound severe disabilities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Project Office, Dept of Paediatrics and Child Health, AKU
Naushero Feroze, Sindh, 75300
About this study
Official title: Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.
Read the detailed description
In Pakistan, the "National Program for Family Planning and Primary Healthcare" delivers maternal and child health and nutrition services in rural and remote areas of Pakistan through community-based Lady Health Workers. The strengths of the programme include provision of services at grassroots levels, reinforcement of health and basic nutrition messages and community acceptability. Given, the growing recognition that optimal early child development (ECD) also requires the integration of psychosocial care; the PEDS-Trial has been proposed to evaluate the benefits of the addition of 'stimulation and care for development' interventions and the feasibility of scaling up an ECD strategy within the community healthcare system of Pakistan.
- Conditions
- Early Child Development and Growth
- Being tested
- Control, ECD, Enhanced Nutrition
- Keywords
- Integrated early child development, growth and health, Psychosocial stimulation, Care for child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
ECDBehavioural
Enhanced NutritionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Routine services for infants and young children delivered by the Lady Health Workers of the National Programme for Family Planning and Primary Healthcare (Basic Health and Nutrition Education and Services) Receives: Behavioral: Control |
| ECD Group | Experimental | Stimulation and care for development (plus basic health and nutrition education and services) Receives: Behavioral: ECD |
| Enhanced Nutrition | Experimental | Care for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services) Receives: Behavioral: Enhanced Nutrition |
| ECD and Enhanced Nutrition | Experimental | Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services) Receives: Behavioral: ECD; Behavioral: Enhanced Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Child Development
Cognitive, Language, Motor, Social-Emotional development
Measured: 24 months of child age
Child Growth
Length/Height, Weight, Mid Arm Circumference, Head Circumference
Measured: 24 months of child age
Secondary outcomes (7)
Caregiving Mediators: Maternal Psychological Distress (Depression)
Self-Reporting Questionnaire (SRQ)-20
Measured: Baseline, 6 months, 12 months, 18 months and 24 months of child age
Caregiving mediators: Caregiving Environment
Home Observation and Measurement of the Environment (HOME) Inventory
Measured: 6 months and 18 months of child age
Caregiving Mediator: Mother/Child Interaction
Live observation
Measured: 12 months and 24 months of child age
Caregiving Mediator: Care for Development
Knowledge and Practices Questionnaire (Maternal Report)
Measured: Baseline, 12 months and 24 months of child age
Caregiving Mediator: Feeding Practices
Maternal report of infant and young child feeding practices
Measured: Baseline, 6 months, 12 months, 18 months and 24 months of child age
Morbidity
Maternal recall
Measured: Monthly report
Anaemia Status
Haemoglobin assessment using HemoCue Assay
Measured: 24 months child age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Child Development and GrowthStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Principal investigator, Dr Aisha Khizar Yousafzai, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, MBBS, PhD, Study chair, Aga Khan UniversityAisha K Yousafzai, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715936
- Sponsor's protocol ID
- 993-PEDS/ERC-08
- Acronym
- PEDS
- Status last verified
- Jun 2017
- First submitted
- 14 Jul 2008
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yousafzai AK, Obradovic J, Rasheed MA, Rizvi A, Portilla XA, Tirado-Strayer N, Siyal S, Memon U. Effects of responsive stimulation and nutrition interventions on children's development and growth at age 4 years in a disadvantaged population in Pakistan: a longitudinal follow-up of a cluster-randomised factorial effectiveness trial. Lancet Glob Health. 2016 Aug;4(8):e548-58. doi: 10.1016/S2214-109X(16)30100-0. Epub 2016 Jun 21.
PubMed 27342433Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16.
PubMed 24947106
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
- ClinicalTrials.gov ID
- NCT00715936
- Acronym / sponsor ID
- PEDS / 993-PEDS/ERC-08
- Conditions
- Early Child Development and Growth
- Keywords
- Integrated early child development, growth and health, Psychosocial stimulation, Care for child development
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,489 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Jul 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Jul 2008 (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.
The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.
Detailed description
In Pakistan, the "National Program for Family Planning and Primary Healthcare" delivers maternal and child health and nutrition services in rural and remote areas of Pakistan through community-based Lady Health Workers. The strengths of the programme include provision of services at grassroots levels, reinforcement of health and basic nutrition messages and community acceptability. Given, the growing recognition that optimal early child development (ECD) also requires the integration of psychosocial care; the PEDS-Trial has been proposed to evaluate the benefits of the addition of 'stimulation and care for development' interventions and the feasibility of scaling up an ECD strategy within the community healthcare system of Pakistan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlRoutine services for infants and young children delivered by the Lady Health Workers of the National Programme for Family Planning and Primary Healthcare (Basic Health and Nutrition Education and Services) |
| ECD Group | Experimental | Behavioral: ECDStimulation and care for development (plus basic health and nutrition education and services) |
| Enhanced Nutrition | Experimental | Behavioral: Enhanced NutritionCare for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services) |
| ECD and Enhanced Nutrition | Experimental | Behavioral: ECD, Behavioral: Enhanced NutritionStimulation and care for development and care for nutrition (plus basic health and nutrition education and services) |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children born in the defined geographical area of study during the study enrollment period will be eligible for the study along with their primary care giver (mother). Infant must be 1d-2.5m of age at time of enrolment.
Key exclusion criteria (1 listed)
- Children born with profound severe disabilities
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 |
|---|---|---|
| Control | Behavioural | Control |
| ECD | Behavioural | ECD Group, ECD and Enhanced Nutrition |
| Enhanced Nutrition | Behavioural | ECD and Enhanced Nutrition, Enhanced Nutrition |
Primary outcome
Early Child Development
Time frame: 24 months of child age
Cognitive, Language, Motor, Social-Emotional development
Child Growth
Time frame: 24 months of child age
Length/Height, Weight, Mid Arm Circumference, Head Circumference
7 secondary outcomes
Caregiving Mediators: Maternal Psychological Distress (Depression)
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months of child age
Caregiving mediators: Caregiving Environment
Time frame: 6 months and 18 months of child age
Caregiving Mediator: Mother/Child Interaction
Time frame: 12 months and 24 months of child age
Caregiving Mediator: Care for Development
Time frame: Baseline, 12 months and 24 months of child age
Caregiving Mediator: Feeding Practices
Time frame: Baseline, 6 months, 12 months, 18 months and 24 months of child age
Morbidity
Time frame: Monthly report
Anaemia Status
Time frame: 24 months child age
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 28 Jun 2017.
- Derived from this study: PubMed 27342433Yousafzai AK, Obradovic J, Rasheed MA, Rizvi A, Portilla XA, Tirado-Strayer N, Siyal S, Memon U. Effects of responsive stimulation and nutrition interventions on children's development and growth at age 4 years in a disadvantaged population in Pakistan: a longitudinal follow-up of a cluster-randomised factorial effectiveness trial. Lancet Glob Health. 2016 Aug;4(8):e548-58. doi: 10.1016/S2214-109X(16)30100-0. Epub 2016 Jun 21.
- Derived from this study: PubMed 24947106Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16.
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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.
Zulfiqar A Bhutta, MBBS, PhD study chair
Aga Khan University
Aisha K Yousafzai, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ECD and Enhanced Nutrition in people with Early Child Development and Growth, run by Aga Khan University at 1 site in Pakistan.
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 1 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: finished, as of the sponsor's last update on 28 Jun 2017. 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 Pakistan. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Early Child Development (time frame: 24 months of child age). The study lists 2 primary outcomes in all. 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 NCT00715936, which also lists 2 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 28 Jun 2017.