NCT04807907

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

March 12, 2021

Last Update Submit

July 23, 2024

Conditions

Keywords

infant directed speech

Outcome Measures

Primary Outcomes (4)

  • Adult word count

    Number of words spoken to child

    10 hours

  • Number of conversational turns

    Number of back-and-forth alternations between a child and an adult during conversation

    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.

    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.

    10 hours

Study Arms (2)

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.

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.

Interventions

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).

Infant Directed Speech (IDS) Video + IDS Calendar

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadult women and infants they are the primary caregiver for.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Must be the biological children (or wards) of the baseline respondents
  • Must be age 2-18 months old during the endline period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 19, 2021

Study Start

March 2, 2021

Primary Completion

December 7, 2021

Study Completion

June 1, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.

Locations