Infant DevelopmentNCT04807907
Promoting Infant-Directed Speech in Ghana
A study testing Infant Directed Speech (IDS) Video + IDS Wall Calendar in people with Infant Development, run by Northwestern University at 1 site in United States.
Trial summary
The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Infant Directed Speech (IDS) Video + IDS Wall Calendar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 1 Jun 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult women who visit government health facilities/outreach posts for antenatal, postnatal, or child welfare clinic visits in Tamale and surrounding areas, Ghana.
- Must be age 18 to 40 years old
- Be either pregnant or mothers of young infants at the time of baseline.
- Must speak English or Dagbani (a language local to Tamale and the surrounding areas)
- The endline survey will also include child participants.
- Child Inclusion Criteria:
- Must be the biological children (or wards) of the baseline respondents
- Must be age 2-18 months old during the endline period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.
Read the detailed description
While parents universally use "baby talk" to soothe an infant or get her attention, engaging in a second form of infant-directed speech (IDS) - talking to young children with complete, if simplified, sentences and a rich variety of words -- varies by socioeconomic status (SES) within societies and across societies. Preliminary evidence collected from Burkina Faso and Ghana, as well as anecdotal experiences in Kenya and Uganda, are consistent with this: It is less common for parents in sub-Saharan Africa to talk to their infants than it is among parents in the US. Because IDS promotes cognitive development of children, gaps in IDS compound the disadvantages that children in poorer families face.
The most likely explanation for the IDS deficit among the poor is inaccurately low expectations about the pace of child development. A large body of literature in the US has shown that the lower the parents' SES, the lower their expectations about when children will master certain cognitive skills, e.g. speaking in a partial sentence of 3 words or more.
The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.
Parental beliefs about and practices of IDS will be evaluated through data obtained from a series of questions on these topics at baseline, during a short phone follow-up survey, and at endline. This will mainly be self-reported although we hope to explore the observation of said practices at endline. Results of the treatment arm will be compared to that of the comparison group to determine if the intervention is effective. To assess IDS behavior and child language development at endline, the LENA system (Language ENvironment Analysis) which produces two key measures It produced two key measures: adult word count (language the child hears) and conversational turns (the sounds/words the child produces in conversation with adults/others) will be compared among groups. Conditional on funding, there may be a 2-year follow-up survey (i.e. second endline) to measure children's cognitive development.
- Conditions
- Infant Development
- Being tested
- Infant Directed Speech (IDS) Video + IDS Wall Calendar
- Keywords
- infant directed speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Directed Speech (IDS) Video + IDS Wall CalendarBehavioural
IDS Video: The IDS video was developed by the research team. It is a simple animation with a voiceover describing the value of IDS and encouraging the viewer to speak to her babies and to tell family members to do so as well. The video has been translated into Dagbani and English (viewers select the language). They may choose to watch it twice.
Breastfeeding women are told by the surveyor following the video, "For instance, you could talk to your baby in full sentences when your baby is breastfeeding."
Wall Calendar: The calendar contains images from the video of parents practicing IDS, and key facts about IDS in bullet points. The 12-month calendar contains an empty star next to each week that the respondent can fill in if they perform IDS at least once a day in that week. The calendar also provides a link to a Facebook page where the respondents can re-watch the video or show it to others (https://www.facebook.com/ghanababytalk/videos).
| Study group | Role | What they receive |
|---|---|---|
| Infant Directed Speech (IDS) Video + IDS Calendar | Experimental | The participant will be shown a 3-minute video describing the value of IDS and how the participant can use IDS with their child. The participant will receive an IDS-themed wall calendar. Receives: Behavioral: Infant Directed Speech (IDS) Video + IDS Wall Calendar |
| Control | No intervention | No intervention. The participant will receive a regular wall calendar with an image of Stanford. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult word count
Number of words spoken to child
Measured: 10 hours
Number of conversational turns
Number of back-and-forth alternations between a child and an adult during conversation
Measured: 10 hours
Self-reported parental beliefs about the value of IDS (Index)
Questionnaire about at what age the participant believes parents should begin speaking, singing, telling stories, etc. to their child using regular speech (i.e. real words, full sentences). Answers will be used to construct an index.
Measured: 10 hours
Self-reported parental IDS behavior (Index)
Questionnaire about whether the participant uses infant directed speech, and if so, the frequency of this behavior. Answers will be used to construct an index.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start2 Mar 2021
- Primary completion7 Dec 2021
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment groups are randomly assigned, as follows: * Infant Directed Speech (IDS) Video (Treatment; 50%): The participant will be shown a 3-minute video describing the value of IDS and how the participant can use IDS with their child. The participant will receive an IDS-themed wall calendar. * Control (50%): No intervention. The participant will receive a regular wall calendar.
- Masking
- None (open label)
- Enrolment
- 2,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807907
- Sponsor's protocol ID
- STU00213766
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Infant-Directed Speech in Ghana
- ClinicalTrials.gov ID
- NCT04807907
- Acronym / sponsor ID
- STU00213766
- Conditions
- Infant Development
- Keywords
- infant directed speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Mar 2021 (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.
The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.
Detailed description
While parents universally use "baby talk" to soothe an infant or get her attention, engaging in a second form of infant-directed speech (IDS) - talking to young children with complete, if simplified, sentences and a rich variety of words -- varies by socioeconomic status (SES) within societies and across societies. Preliminary evidence collected from Burkina Faso and Ghana, as well as anecdotal experiences in Kenya and Uganda, are consistent with this: It is less common for parents in sub-Saharan Africa to talk to their infants than it is among parents in the US. Because IDS promotes cognitive development of children, gaps in IDS compound the disadvantages that children in poorer families face.
The most likely explanation for the IDS deficit among the poor is inaccurately low expectations about the pace of child development. A large body of literature in the US has shown that the lower the parents' SES, the lower their expectations about when children will master certain cognitive skills, e.g. speaking in a partial sentence of 3 words or more.
The study is a randomized evaluation of a low-cost intervention that encourages mothers and other caregivers to talk to infants, or to engage in what is known as infant-directed speech (IDS) as a way of promoting language and brain development in Tamale and surrounding areas, Ghana.
Parental beliefs about and practices of IDS will be evaluated through data obtained from a series of questions on these topics at baseline, during a short phone follow-up survey, and at endline. This will mainly be self-reported although we hope to explore the observation of said practices at endline. Results of the treatment arm will be compared to that of the comparison group to determine if the intervention is effective. To assess IDS behavior and child language development at endline, the LENA system (Language ENvironment Analysis) which produces two key measures It produced two key measures: adult word count (language the child hears) and conversational turns (the sounds/words the child produces in conversation with adults/others) will be compared among groups. Conditional on funding, there may be a 2-year follow-up survey (i.e. second endline) to measure children's cognitive development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment groups are randomly assigned, as follows: * Infant Directed Speech (IDS) Video (Treatment; 50%): The participant will be shown a 3-minute video describing the value of IDS and how the participant can use IDS with their child. The participant will receive an IDS-themed wall calendar. * Control (50%): No intervention. The participant will receive a regular wall calendar.
| Arm | Type | Receives |
|---|---|---|
| Infant Directed Speech (IDS) Video + IDS Calendar | Experimental | Behavioral: Infant Directed Speech (IDS) Video + IDS Wall CalendarThe participant will be shown a 3-minute video describing the value of IDS and how the participant can use IDS with their child. The participant will receive an IDS-themed wall calendar. |
| Control | No intervention | –No intervention. The participant will receive a regular wall calendar with an image of Stanford. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult women who visit government health facilities/outreach posts for antenatal, postnatal, or child welfare clinic visits in Tamale and surrounding areas, Ghana.
- Must be age 18 to 40 years old
- Be either pregnant or mothers of young infants at the time of baseline.
- Must speak English or Dagbani (a language local to Tamale and the surrounding areas)
- The endline survey will also include child participants.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Infant Directed Speech (IDS) Video + IDS Wall CalendarIDS Video: The IDS video was developed by the research team. It is a simple animation with a voiceover describing the value of IDS and encouraging the viewer to speak to her babies and to tell family members to do so as well. The video has been translated into Dagbani and English (viewers select the language). They may choose to watch it twice. Breastfeeding women are told by the surveyor following the video, "For instance, you could talk to your baby in full sentences when your baby is breastfeeding." Wall Calendar: The calendar contains images from the video of parents practicing IDS, and key facts about IDS in bullet points. The 12-month calendar contains an empty star next to each week that the respondent can fill in if they perform IDS at least once a day in that week. The calendar also provides a link to a Facebook page where the respondents can re-watch the video or show it to others (https://www.facebook.com/ghanababytalk/videos). | Behavioural | Infant Directed Speech (IDS) Video + IDS Calendar |
Primary outcome
Adult word count
Time frame: 10 hours
Number of words spoken to child
Number of conversational turns
Time frame: 10 hours
Number of back-and-forth alternations between a child and an adult during conversation
Self-reported parental beliefs about the value of IDS (Index)
Time frame: 10 hours
Questionnaire about at what age the participant believes parents should begin speaking, singing, telling stories, etc. to their child using regular speech (i.e. real words, full sentences). Answers will be used to construct an index.
Self-reported parental IDS behavior (Index)
Time frame: 10 hours
Questionnaire about whether the participant uses infant directed speech, and if so, the frequency of this behavior. Answers will be used to construct an index.
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 24 Jul 2024.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Directed Speech (IDS) Video + IDS Wall Calendar in people with Infant Development, run by Northwestern University at 1 site in United States.
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 8 inclusion and 0 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 24 Jul 2024. 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 United States. 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?
Adult word count (time frame: 10 hours). The study lists 4 primary outcomes in all. 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 24 Jul 2024.