Child DevelopmentNCT03732911
Developmental Monitoring and Language Promotion
A study testing Intervention in people with Child Development, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this study is to pilot test an intervention developed to enhance parent knowledge regarding child development and encourage parents to engage in activities that promote language acquisition. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 30 Jun 2019
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preferred language either English or Spanish,
- Parent or legal guardian,
- Age ≥ 18 years,
- Willing to accept text messages
- Child ≤ 20 months old
Who cannot join
- Individuals unable to provide consent
- Individuals who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
The goal of this study is to pilot test an intervention developed to enhance parent knowledge regarding child development and encourage parents to engage in activities that promote language acquisition.
Read the detailed description
Our specific aim for this proposal is to pilot test an intervention developed to enhance parent knowledge regarding child development and the home cognitive environment comprised of distribution of (1) publicly available developmental monitoring materials, (2) age and language appropriate children's books, and (3) text message reminders. Participants in this intervention will receive: (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two text messages per week for a 6-month period. Differences in pre- and post-intervention knowledge regarding child development and the home cognitive environment will be assessed.
- Conditions
- Child Development
- Being tested
- Intervention
- Keywords
- Child Development, Cognitive Home Environment, Literacy promotion, Text Messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Participants will receive the following intervention bundle (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two tailored text messages per week for a 6-month period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention arm Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of child development
We will ask parents to respond to questions regarding child development upon enrollment and at 6-month follow-up.Knowledge questions are based on CDC materials and evidence based screening tools.
Measured: Visit 2 (6 months)
Secondary outcomes (2)
Home cognitive environment:
The StimQ2 is a validated, parent-report measure of the cognitive home environment for children that assesses 4 domains: (1) availability of learning materials, (2) reading, (3) parent involvement in developmental advancement, and (4) parental verbal responsiveness. We will administer the Reading and Parental Verbal Response Scale. Participants will be asked to complete the StimQ2 pre- and post-intervention.
Measured: Visit 2 (6 months)
Frequency Shared Reading:
To measure how often parents read to their children, they will be asked to respond to the following question at enrollment and at 6-month follow-up, "How often did you read to your child in the last week?"
Measured: Visit 2 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start12 Nov 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732911
- Sponsor's protocol ID
- Pro2018001244
- Status last verified
- Jun 2019
- First submitted
- 5 Nov 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Monitoring and Language Promotion
- ClinicalTrials.gov ID
- NCT03732911
- Acronym / sponsor ID
- Pro2018001244
- Conditions
- Child Development
- Keywords
- Child Development, Cognitive Home Environment, Literacy promotion, Text Messages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Nov 2018 (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 goal of this study is to pilot test an intervention developed to enhance parent knowledge regarding child development and encourage parents to engage in activities that promote language acquisition.
Detailed description
Our specific aim for this proposal is to pilot test an intervention developed to enhance parent knowledge regarding child development and the home cognitive environment comprised of distribution of (1) publicly available developmental monitoring materials, (2) age and language appropriate children's books, and (3) text message reminders. Participants in this intervention will receive: (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two text messages per week for a 6-month period. Differences in pre- and post-intervention knowledge regarding child development and the home cognitive environment will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionIntervention arm |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Preferred language either English or Spanish,
- Parent or legal guardian,
- Age ≥ 18 years,
- Willing to accept text messages
- Child ≤ 20 months old
Key exclusion criteria (2 listed)
- Individuals unable to provide consent
- Individuals who do not meet inclusion criteria
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 |
|---|---|---|
| InterventionParticipants will receive the following intervention bundle (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two tailored text messages per week for a 6-month period. | Behavioural | Intervention |
Primary outcome
Knowledge of child development
Time frame: Visit 2 (6 months)
We will ask parents to respond to questions regarding child development upon enrollment and at 6-month follow-up.Knowledge questions are based on CDC materials and evidence based screening tools.
2 secondary outcomes
Home cognitive environment:
Time frame: Visit 2 (6 months)
Frequency Shared Reading:
Time frame: Visit 2 (6 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 10 Jul 2019.
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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 Intervention in people with Child Development, run by Rutgers, The State University of New Jersey 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 5 inclusion and 2 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 10 Jul 2019. 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?
Knowledge of child development (time frame: Visit 2 (6 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 10 Jul 2019.