Child DevelopmentNCT02545491
Implementation and Adoption of Care for Child Development in Day Care Centers
A study testing Care for Child Development (CCD) program and Infant and Young Child feeding training by World Vision in people with Child Development, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Background: Responsive stimulation and/or enhanced nutrition interventions delivered to children through health programs shows improved cognitive, language, and motor, and the social-emotional status. This could benefit young children in Lebanon and worldwide to improve their developmental potential. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Care for Child Development (CCD) program and Infant and Young Child feeding training by World Vision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2015to Nov 2017
- 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 Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 0 to 3 years registered in the selected daycare centers.
Who cannot join
- Children diagnosed with medical conditions that might affect developmental assessment, or who are older than the specified ages will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Care for Child Development and Implications on Early Childhood Development: A Pilot Study in Lebanon
Background: Responsive stimulation and/or enhanced nutrition interventions delivered to children through health programs shows improved cognitive, language, and motor, and the social-emotional status. This could benefit young children in Lebanon and worldwide to improve their developmental potential.
Aim: This study aims to implement Care for Child Development (CCD) intervention for children aged 0-3 years within a supportive environment in Day Care Centers and to investigate its effectiveness on early child development.
Read more
Methodology: CCD program will be implemented in 10 randomly selected daycare centers in Lebanon where three providers in each center will be trained (CCD-group). Another group of 10 day care centers will serve as controls (WV-group). 228 Children in each group will receive either early stimulation based on CCD and education from the World Vision Infant and Young Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project (WV-group). Caregivers' knowledge and behaviors will be assessed before and after the intervention using a predetermined questionnaire and behavioral checklist. Early child development will be assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale for infant Development (BSID-III).
Expected Outcome: Implementation of CCD program in day care centers will be feasible and will lead to enhanced early child development. This study will serve as a prototype for program implementation throughout the country and the region.
Read the detailed description
This study aims at testing the implementation and effectiveness of the CCD program on early child development in selected day care centers in Beirut. It is being conducted in collaboration with World Vision and the Lebanese Ministry of Public Health.
Day Care centers are invited by the ministry of health to participate in this proposed study.
After securing the approval of the Center's director, caregivers working at those day care centers are being invited to participate in this study.
Those caregivers who agree to participate will receive either training on the CCD program AND early child nutrition from World Vision (Infant \& Young Child Feeding Project WV-IYCFP) (Intervention group) or training on early child nutrition from WV-IYCFP only (control group).
The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides caregivers with recommendations for stimulating child development through play and communication activities.
WV-IYCFP provides activities related to raising awareness on breastfeeding and complementary food introduction to optimize child nutrition.
The Intervention group (CCD-Group) consists of 10 day care centers chosen randomly. Three caregivers from each center (total 30 caregivers) will attend a day-and-a-half CCD training at the Center of Excellence for Early Child Development at AUBMC. In addition, they will participate in the World Vision activities related to the Infant \& Young Child Feeding Project (WV-IYCFP). The day care centers in this group will receive a manual including early child development concepts and techniques to be used as a reference.
The Control group (WV-Group) consists of 10 day care centers chosen randomly. Three caregivers from each center (total 30 caregivers) will participate in activities related to the WV-IYCFP.
Caregivers in both groups will be asked to take a knowledge assessment questionnaire on child development before and after each training, then at 6months and 12 months after the intervention.
In both groups, caregivers' behavior in early child stimulation will be assessed before and after the trainings. Caregivers will be observed delivering child care as per each center's routine; their behavior will be assessed using a predetermined behavioral check list developed based on the CCD program.
- Conditions
- Child Development
- Being tested
- Care for Child Development (CCD) program, Infant and Young Child feeding training by World Vision
- Keywords
- CCD, Child development, daycare, caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care for Child Development (CCD) programBehavioural
The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides recommendations for stimulating child development through play and communication activities.
Infant and Young Child feeding training by World VisionBehavioural
Training on breastfeeding benefits, solid introduction and food safety
| Study group | Role | What they receive |
|---|---|---|
| Care for Child Development group | Experimental | Training of caregivers on the Care for Child Development (CCD) program, in addition to the training on Infant and Young Child feeding program by World Vision. Receives: Behavioral: Care for Child Development (CCD) program; Behavioral: Infant and Young Child feeding training by World Vision |
| World Vision Lebanon training group | Active comparator | caregivers will receive training in Infant and Young Child Feeding (WV-IYCF) offered by World Vision. Receives: Behavioral: Infant and Young Child feeding training by World Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancing child development. (developmental scores by BSID-III )
Children in the CCD-group will have better developmental scores by BSID-III compared to those in the WV- group.
Measured: one year
Secondary outcomes (2)
Caregivers' knowledge (measured by pre and post assessement test)
Caregivers in the intervention group will have at least 25% improvement in the 12 items knowledge assessment questionnaire after the intervention.
Measured: one year
Caregivers' behavior (measured by behavioral observation using predetermined checklist)
Caregivers' behavioral checklist scores (after the intervention) will be of at least 8 out of 10 for those in the intervention group.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionNov 2017
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- World Vision, Ministry of Public Health, Lebanon
- Responsible party
- Principal investigator, Lama Charafeddine, American University of Beirut Medical Center
- Investigators
- Durriyah Sinno, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545491
- Sponsor's protocol ID
- PED.DS.03
- Status last verified
- Jul 2018
- First submitted
- 25 Aug 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson LM, Shinn C, Fullilove MT, Scrimshaw SC, Fielding JE, Normand J, Carande-Kulis VG; Task Force on Community Preventive Services. The effectiveness of early childhood development programs. A systematic review. Am J Prev Med. 2003 Apr;24(3 Suppl):32-46. doi: 10.1016/s0749-3797(02)00655-4.
PubMed 12668197Bryanton J, Beck CT. Postnatal parental education for optimizing infant general health and parent-infant relationships. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004068. doi: 10.1002/14651858.CD004068.pub3.
PubMed 20091558
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Care for Child Development and Implications on Early Childhood Development: A Pilot Study in Lebanon
- ClinicalTrials.gov ID
- NCT02545491
- Acronym / sponsor ID
- PED.DS.03
- Conditions
- Child Development
- Keywords
- CCD, Child development, daycare, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- World Vision, Ministry of Public Health, Lebanon
- Study start
- Jan 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 10 Sep 2015 (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.
Background: Responsive stimulation and/or enhanced nutrition interventions delivered to children through health programs shows improved cognitive, language, and motor, and the social-emotional status. This could benefit young children in Lebanon and worldwide to improve their developmental potential.
Aim: This study aims to implement Care for Child Development (CCD) intervention for children aged 0-3 years within a supportive environment in Day Care Centers and to investigate its effectiveness on early child development.
Methodology: CCD program will be implemented in 10 randomly selected daycare centers in Lebanon where three providers in each center will be trained (CCD-group). Another group of 10 day care centers will serve as controls (WV-group). 228 Children in each group will receive either early stimulation based on CCD and education from the World Vision Infant and Young Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project (WV-group). Caregivers' knowledge and behaviors will be assessed before and after the intervention using a predetermined questionnaire and behavioral checklist. Early child development will be assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale for infant Development (BSID-III).
Expected Outcome: Implementation of CCD program in day care centers will be feasible and will lead to enhanced early child development. This study will serve as a prototype for program implementation throughout the country and the region.
Detailed description
This study aims at testing the implementation and effectiveness of the CCD program on early child development in selected day care centers in Beirut. It is being conducted in collaboration with World Vision and the Lebanese Ministry of Public Health.
Day Care centers are invited by the ministry of health to participate in this proposed study.
After securing the approval of the Center's director, caregivers working at those day care centers are being invited to participate in this study.
Those caregivers who agree to participate will receive either training on the CCD program AND early child nutrition from World Vision (Infant \& Young Child Feeding Project WV-IYCFP) (Intervention group) or training on early child nutrition from WV-IYCFP only (control group).
The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides caregivers with recommendations for stimulating child development through play and communication activities.
WV-IYCFP provides activities related to raising awareness on breastfeeding and complementary food introduction to optimize child nutrition.
The Intervention group (CCD-Group) consists of 10 day care centers chosen randomly. Three caregivers from each center (total 30 caregivers) will attend a day-and-a-half CCD training at the Center of Excellence for Early Child Development at AUBMC. In addition, they will participate in the World Vision activities related to the Infant \& Young Child Feeding Project (WV-IYCFP). The day care centers in this group will receive a manual including early child development concepts and techniques to be used as a reference.
The Control group (WV-Group) consists of 10 day care centers chosen randomly. Three caregivers from each center (total 30 caregivers) will participate in activities related to the WV-IYCFP.
Caregivers in both groups will be asked to take a knowledge assessment questionnaire on child development before and after each training, then at 6months and 12 months after the intervention.
In both groups, caregivers' behavior in early child stimulation will be assessed before and after the trainings. Caregivers will be observed delivering child care as per each center's routine; their behavior will be assessed using a predetermined behavioral check list developed based on the CCD program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care for Child Development group | Experimental | Behavioral: Care for Child Development (CCD) program, Behavioral: Infant and Young Child feeding training by World VisionTraining of caregivers on the Care for Child Development (CCD) program, in addition to the training on Infant and Young Child feeding program by World Vision. |
| World Vision Lebanon training group | Active comparator | Behavioral: Infant and Young Child feeding training by World Visioncaregivers will receive training in Infant and Young Child Feeding (WV-IYCF) offered by World Vision. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 0 to 3 years registered in the selected daycare centers.
Key exclusion criteria (1 listed)
- Children diagnosed with medical conditions that might affect developmental assessment, or who are older than the specified ages will not be included in the study.
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 |
|---|---|---|
| Care for Child Development (CCD) programThe Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides recommendations for stimulating child development through play and communication activities. | Behavioural | Care for Child Development group |
| Infant and Young Child feeding training by World VisionTraining on breastfeeding benefits, solid introduction and food safety | Behavioural | Care for Child Development group, World Vision Lebanon training group |
Primary outcome
Enhancing child development. (developmental scores by BSID-III )
Time frame: one year
Children in the CCD-group will have better developmental scores by BSID-III compared to those in the WV- group.
2 secondary outcomes
Caregivers' knowledge (measured by pre and post assessement test)
Time frame: one year
Caregivers' behavior (measured by behavioral observation using predetermined checklist)
Time frame: one year
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 6 Jul 2018.
- Background: PubMed 12668197Anderson LM, Shinn C, Fullilove MT, Scrimshaw SC, Fielding JE, Normand J, Carande-Kulis VG; Task Force on Community Preventive Services. The effectiveness of early childhood development programs. A systematic review. Am J Prev Med. 2003 Apr;24(3 Suppl):32-46. doi: 10.1016/s0749-3797(02)00655-4.
- Background: PubMed 20091558Bryanton J, Beck CT. Postnatal parental education for optimizing infant general health and parent-infant relationships. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004068. doi: 10.1002/14651858.CD004068.pub3.
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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.
Durriyah Sinno, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care for Child Development (CCD) program and Infant and Young Child feeding training by World Vision in people with Child Development, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 6 Jul 2018. 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 Lebanon. 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 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?
Enhancing child development. (developmental scores by BSID-III ) (time frame: one year). 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 NCT02545491, 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 6 Jul 2018.