Child DevelopmentNCT01466933
Responsive Parenting Program for Infants in Rural Bangladesh
A study testing Responsive parenting and Child Development in people with Child Development, run by McGill University at 1 site in Bangladesh.
Trial summary
Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. Read more about this study
- Who is it for?
- Ages 6 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Responsive parenting and Child Development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2011to Mar 2012
- 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 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mother has a child 6 to 14 months of age
- mother willing to learn about child care
Who cannot join
- not severely disabled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design, Implementation and Evaluation of a Parent Support/Counselling Program With a Focus on Responsive Stimulation for Infants and Young Children in Rural Bangladesh
Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.
Read the detailed description
There are actually two intervention groups: in one the program is delivered by trained peer educators from the village, and in the other the program is delivered by trained government personnel.
- Conditions
- Child Development
- Being tested
- Responsive parenting, Child Development
- Keywords
- parenting intervention, child development, low and middle income countries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsive parentingBehavioural
On a monthly basis, mothers meet with the peer educator to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. Mothers practice with their child and are coached by the peer educator.
Child DevelopmentBehavioural
On a monthly basis, mothers meet with the government worker to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development.
| Study group | Role | What they receive |
|---|---|---|
| Community-based | Experimental | Community trained peer educator delivers parenting sessions to mothers in the village on a monthly basis Receives: Behavioral: Responsive parenting |
| Government-based | Active comparator | Government community health workers, trained, deliver the intervention to mothers in the village Receives: Behavioral: Child Development |
| Control | No intervention | Mothers receive the standard care which is a visit from the health worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley scales of infant development
Cognitive, receptive language and expressive language items will be administered to the child and scored as pass/fail with a total score calculated for each subtest and the total.
Measured: 12 months
Secondary outcomes (5)
HOME Inventory
45 items assessing through observation and interview opportunities for stimulation in the home.
Measured: 12 months
Mother-Child picture talk
Mothers' responsive talk while looking at pictures with her child.
Measured: 12 months
Dietary diversity
Number out of 7 categories of food, based on Mothers recall foods fed to their child over a 24-hour period.
Measured: 12 months
Child development knowledge of mother
Mothers report the age when they expect children to start acquiring 10 psychosocial skills, e.g. recognize its mother.
Measured: 12 months
height for age
height for age z score is derived from the current WHO growth standards
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children
- Responsible party
- Principal investigator, Frances Aboud, McGill University
- Investigators
- Frances Aboud, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466933
- Sponsor's protocol ID
- REB#420-0510
- Status last verified
- Jul 2013
- First submitted
- 4 Nov 2011
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Implementation and Evaluation of a Parent Support/Counselling Program With a Focus on Responsive Stimulation for Infants and Young Children in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT01466933
- Acronym / sponsor ID
- REB#420-0510
- Conditions
- Child Development
- Keywords
- parenting intervention, child development, low and middle income countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Save the Children
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Nov 2011 (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.
Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.
Detailed description
There are actually two intervention groups: in one the program is delivered by trained peer educators from the village, and in the other the program is delivered by trained government personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community-based | Experimental | Behavioral: Responsive parentingCommunity trained peer educator delivers parenting sessions to mothers in the village on a monthly basis |
| Government-based | Active comparator | Behavioral: Child DevelopmentGovernment community health workers, trained, deliver the intervention to mothers in the village |
| Control | No intervention | –Mothers receive the standard care which is a visit from the health worker |
Who may qualify
- Ages
- 6 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- mother has a child 6 to 14 months of age
- mother willing to learn about child care
Key exclusion criteria (1 listed)
- not severely disabled
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 |
|---|---|---|
| Responsive parentingOn a monthly basis, mothers meet with the peer educator to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. Mothers practice with their child and are coached by the peer educator. | Behavioural | Community-based |
| Child DevelopmentOn a monthly basis, mothers meet with the government worker to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. | Behavioural | Government-based |
Primary outcome
Bayley scales of infant development
Time frame: 12 months
Cognitive, receptive language and expressive language items will be administered to the child and scored as pass/fail with a total score calculated for each subtest and the total.
5 secondary outcomes
HOME Inventory
Time frame: 12 months
Mother-Child picture talk
Time frame: 12 months
Dietary diversity
Time frame: 12 months
Child development knowledge of mother
Time frame: 12 months
height for age
Time frame: 12 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 18 Jul 2013.
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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.
Frances Aboud, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsive parenting and Child Development in people with Child Development, run by McGill University at 1 site in Bangladesh.
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 2 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 18 Jul 2013. 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 Bangladesh. 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?
Bayley scales of infant development (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2013.