Infant DevelopmentNCT05259423
The Effects on Children and Parents of Educating Parents About Ways to Play With Babies
A study testing Enriched Education Program and Typical Education Program in people with Infant Development and Developmental Delay, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to determine whether educating parents about how to play with infants affects infant development or caregiver characteristics. The project will comparatively evaluate the effects of two different play education programs on infants' development and on caregiver characteristics in a sample… Read more about this study
- Who is it for?
- Ages 1 month to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Developmental Delay
- What is being tested?
- Enriched Education Program and Typical Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 10 Nov 2023
- 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 1 month to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Able to engage in the data collection activities and be available for either in-person or virtual visits
- Parent participating in the study must be at least 18 years of age
- Parent must be able to speak and read in English
- Parent must be physically capable of performing the play activities with their infant (i.e., able to carry the infant and play on the floor with the infant).
- If parents choose to participate virtually, they must report having a device with a camera and microphone for the use of Zoom and access to the internet.
- Infants must be between the ages of 1 month and 6 months at enrollment
- Infants must not be legally blind
- Infants who meet the criteria for the State of Delaware Early Intervention Inclusion Criteria will be included in the at-risk group. These criteria are: 1) established conditions, such as chromosomal disorders, genetic disorders, and neurologic disorders; or 2) developmental delay measured via a standardized developmental assessment (e.g., the DAY-C).
Who cannot join
- None beyond inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether educating parents about how to play with infants affects infant development or caregiver characteristics.
The project will comparatively evaluate the effects of two different play education programs on infants' development and on caregiver characteristics in a sample of infants with typical development and a sample of infants with/at risk for developmental delay.
Read the detailed description
Parents are the primary source of interaction for their infants; they determine their infants' daily experiences and provide opportunities for growth and learning that have cascading, longitudinal effects. Early experiences may be even more important for infants who are at risk of developmental delays. In the United States, one out of every six children ages 3-17 will be diagnosed with one or multiple developmental disabilities, and the prevalence is growing. While some children with developmental disabilities or delays benefit from early intervention (EI) services in this critical period, enrollment rates for eligible children are disturbingly low, with only 5-10% of children with delays receiving EI services at 24 months of age. For these children who do not receive EI services during this critical window for neuroplasticity and learning, parents are the primary persons tasked with independently creating opportunities for their infants' developmental growth. The purpose of this study is to improve our understanding of early parent education and to determine whether or how parent education changes child outcomes (i.e., developmental scores) and parental characteristics (i.e., physical and social setting, customs, parent psychology). The investigators will conduct a pilot randomized controlled trial with a parallel design enrolling parents and infants ages 1-6 months with typical development or with/at risk of developmental delays. The investigators will use blocked randomization to control for socioeconomic status, as this is a known factor that can impact infant development, to assign parent-infant dyads to receive either the Enriched Education Program (EEP) or the Typical Education Program (TEP). Parents will receive written, illustrated instructions describing nine play activities; they will be asked to perform three activities each day (5 minutes each, 15 minutes total per day), logging their activity for 4 weeks. EEP activities were designed to implement EI and developmental science principles, while TEP activities represent common activities described on parenting websites, books, and mobile applications. Participants will be evaluated longitudinally across five visits using a variety of measures of child development and parental characteristics: at pre-intervention (baseline), post-intervention (1 month), and at follow-up visits (1-, 2-, and 5-month follow-up). In addition, infants' motor milestone development will be tracked through the onset of walking. The effect of the interventions on child developmental outcomes and parental characteristics will be evaluated for infants with typical development and infants at risk/with developmental delays. Usability of the educational programs will also be evaluated. The results of this study may help inform future parent education interventions.
- Conditions
- Infant Development, Developmental Delay
- Being tested
- Enriched Education Program, Typical Education Program
- Keywords
- Education, Parents, Infant, Motor Activity, Cognition, Infant development, language development, Infant health
- Medical subject headings
- Learning Disabilities, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Education ProgramOther
Enriched play activity education including 9 different activities each with 3 levels depending on the infant's current head and trunk control. Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day.
Typical Education ProgramOther
Typical play activity education including 9 activities commonly described by popular parenting websites, mobile applications, and books. Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Typical Development, Enriched Education Program | Experimental | Parents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development. Receives: Other: Enriched Education Program |
| Typical Development, Typical Education Program | Active comparator | Parents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books. Receives: Other: Typical Education Program |
| Developmental Delay, Enriched Education Program | Experimental | Parents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development. Receives: Other: Enriched Education Program |
| Developmental Delay, Typical Education Program | Active comparator | Parents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books. Receives: Other: Typical Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infant Motor Development
Assessed with the Alberta Infant Motor Scale, an observational measure of motor performance in prone, supine, sitting, and standing positions through a total score and sub-scale scores. Total Score: Minimum: 0; Maximum: 60; Higher score indicating more advanced motor development
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Infant Developmental Outcomes
Assessed with the Developmental Assessment of Young Children- 2nd Edition, an assessment of motor, cognitive, and language development through subdomain and standard scores, as well as a general developmental index (normative cumulative score). Standard scores range from <70 to >130 with higher scores indicating more advanced development.
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Play Behaviors: Positioning
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to Positioning: Number of Bouts and percent time in prone, reclined, supine, side-lying, seated, standing, and held.
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Play Behaviors: Handling
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to Handling: Number of bouts and percent time with support by a container or parent at the head, upper trunk, lower trunk in prone, reclined, supine, side-lying, seated, standing, held positions.
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Play Behaviors: Communication
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to communication: Communication: Number of words (total and number unique), babbling, style (fluctuation in pitch, responsiveness/turn-taking, gestures while communicating, labeling objects).
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Play Behaviors: Toys
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to toys: Frequency of toy use, number of unique toys, location of toys (Number of bouts and percent time in reach; Number of bouts and Percent time within-grasp).
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Usability and Feasibility of the Intervention
The usability and feasibility of both interventions (Enriched Education and Typical Education) will be assessed using a Perception Questionnaire with 7-point Likert Scales (1= Completely Disagree; 7 = Completely Agree) including the meaningfulness and ease of use of the activities.
Measured: 1-month from start of study
Secondary outcomes (9)
Change in Daily Positioning
A position tracking garment, the get-around-garment will be worn during awake times for 2 days to determine the time spent in supine, prone, and upright positions.
Measured: 2 days surrounding each of the 5 visits: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Infant Object Exploration
Assessed with the Object Exploration Assessment, which measures visual-manual interactions when infants are provided with specific objects (7) with varying properties for 30 seconds each to determine exploration time, bouts of exploration, individual behaviors (i.e., mouthing, looking, touching body, bilateral holding) and multimodal behaviors (i.e., looking while acting).
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Language Development
The Preschool Language Scales-5th Edition will be given to assess language development including preverbal, interaction-based language skills in the domains of auditory comprehension, and expressive communication standard scores as well as a total language score.
Measured: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Beliefs about Development
Parental beliefs will be measured with the Parental Beliefs on Motor Development scaled score and the Parental Knowledge and Beliefs Questionnaire which was developed to measure parent knowledge and beliefs about motor, cognitive and language development using 7-point Likert Scales. Items related to each developmental domain (motor, cognitive, language) will be summed to get a domain score in addition to a total score (sum).
Measured: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Knowledge about Development
Parental knowledge about language and cognitive development will be measured with the Survey of Parent/Provider Expectations and Knowledge and parent knowledge about motor development will be assessed with the Parental Knowledge and Beliefs Questionnaire using 7-point Likert Scales.Items related to each developmental domain (motor, cognitive, language) will be summed to get a domain score in addition to a total score (sum).
Measured: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parent Beliefs and Knowledge about Play
The Parent Play Questionnaire will survey parents' beliefs and knowledge about play with infants.
Measured: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parenting Confidence
The Karitane Parenting Confidence Scale will assess parents' confidence in their parenting abilities. Higher scores indicate greater parenting confidence.
Measured: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Practices regarding Motor Development
The Motor Habits Questionnaire will be used to measure parents' practices regarding motor development.
Measured: Baseline (start of study), 3-months from start of study, 6-months from start of study
Change in the Time of Achieving Developmental Milestones
The Parental Milestone Report will be used to track the timing of the development of key developmental milestones through the onset of independent walking.
Measured: Reported at Baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (Typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Apr 2022
- Primary completion1 May 2023
- Study completion10 Nov 2023
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to receive the Enriched Education Program (EEP) or the Typical Education Program (TEP).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Lobo, University of Delaware
- Investigators
- Michele A Lobo, PT, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259423
- Sponsor's protocol ID
- 1858581-1
- Status last verified
- May 2024
- First submitted
- 3 Feb 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A data sharing agreement is in place for the University of Delaware and the University of Chicago to share deidentified SPEAK-R and demographic data including: parent participant's age in years, highest level of school completed/highest degree obtained, race, and ethnicity age in years and highest level of school completed/highest degree obtained for other adult(s) living in the household, infant participant's race, ethnicity, and sex, and approximate total annual household income before taxes which the University of Chicago will use towards establishing the reliability of the SPEAK-R and publishing research articles.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Children and Parents of Educating Parents About Ways to Play With Babies
- ClinicalTrials.gov ID
- NCT05259423
- Acronym / sponsor ID
- 1858581-1
- Conditions
- Infant Development, Developmental Delay
- Keywords
- Education, Parents, Infant, Motor Activity, Cognition, Infant development, language development, Infant health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 28 Feb 2022 (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 purpose of this study is to determine whether educating parents about how to play with infants affects infant development or caregiver characteristics.
The project will comparatively evaluate the effects of two different play education programs on infants' development and on caregiver characteristics in a sample of infants with typical development and a sample of infants with/at risk for developmental delay.
Detailed description
Parents are the primary source of interaction for their infants; they determine their infants' daily experiences and provide opportunities for growth and learning that have cascading, longitudinal effects. Early experiences may be even more important for infants who are at risk of developmental delays. In the United States, one out of every six children ages 3-17 will be diagnosed with one or multiple developmental disabilities, and the prevalence is growing. While some children with developmental disabilities or delays benefit from early intervention (EI) services in this critical period, enrollment rates for eligible children are disturbingly low, with only 5-10% of children with delays receiving EI services at 24 months of age. For these children who do not receive EI services during this critical window for neuroplasticity and learning, parents are the primary persons tasked with independently creating opportunities for their infants' developmental growth. The purpose of this study is to improve our understanding of early parent education and to determine whether or how parent education changes child outcomes (i.e., developmental scores) and parental characteristics (i.e., physical and social setting, customs, parent psychology). The investigators will conduct a pilot randomized controlled trial with a parallel design enrolling parents and infants ages 1-6 months with typical development or with/at risk of developmental delays. The investigators will use blocked randomization to control for socioeconomic status, as this is a known factor that can impact infant development, to assign parent-infant dyads to receive either the Enriched Education Program (EEP) or the Typical Education Program (TEP). Parents will receive written, illustrated instructions describing nine play activities; they will be asked to perform three activities each day (5 minutes each, 15 minutes total per day), logging their activity for 4 weeks. EEP activities were designed to implement EI and developmental science principles, while TEP activities represent common activities described on parenting websites, books, and mobile applications. Participants will be evaluated longitudinally across five visits using a variety of measures of child development and parental characteristics: at pre-intervention (baseline), post-intervention (1 month), and at follow-up visits (1-, 2-, and 5-month follow-up). In addition, infants' motor milestone development will be tracked through the onset of walking. The effect of the interventions on child developmental outcomes and parental characteristics will be evaluated for infants with typical development and infants at risk/with developmental delays. Usability of the educational programs will also be evaluated. The results of this study may help inform future parent education interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be assigned to receive the Enriched Education Program (EEP) or the Typical Education Program (TEP).
| Arm | Type | Receives |
|---|---|---|
| Typical Development, Enriched Education Program | Experimental | Other: Enriched Education ProgramParents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development. |
| Typical Development, Typical Education Program | Active comparator | Other: Typical Education ProgramParents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books. |
| Developmental Delay, Enriched Education Program | Experimental | Other: Enriched Education ProgramParents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development. |
| Developmental Delay, Typical Education Program | Active comparator | Other: Typical Education ProgramParents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Able to engage in the data collection activities and be available for either in-person or virtual visits
- Parent participating in the study must be at least 18 years of age
- Parent must be able to speak and read in English
- Parent must be physically capable of performing the play activities with their infant (i.e., able to carry the infant and play on the floor with the infant).
- If parents choose to participate virtually, they must report having a device with a camera and microphone for the use of Zoom and access to the internet.
Key exclusion criteria (1 listed)
- None beyond 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 |
|---|---|---|
| Enriched Education ProgramEnriched play activity education including 9 different activities each with 3 levels depending on the infant's current head and trunk control. Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day. | Other | Developmental Delay, Enriched Education Program, Typical Development, Enriched Education Program |
| Typical Education ProgramTypical play activity education including 9 activities commonly described by popular parenting websites, mobile applications, and books. Parents will be instructed to complete 3 activities each day for at least 5 minutes each for a total of 15 minutes per day. | Other | Developmental Delay, Typical Education Program, Typical Development, Typical Education Program |
Primary outcome
Change in Infant Motor Development
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Assessed with the Alberta Infant Motor Scale, an observational measure of motor performance in prone, supine, sitting, and standing positions through a total score and sub-scale scores. Total Score: Minimum: 0; Maximum: 60; Higher score indicating more advanced motor development
Change in Infant Developmental Outcomes
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Assessed with the Developmental Assessment of Young Children- 2nd Edition, an assessment of motor, cognitive, and language development through subdomain and standard scores, as well as a general developmental index (normative cumulative score). Standard scores range from <70 to >130 with higher scores indicating more advanced development.
Change in Parental Play Behaviors: Positioning
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to Positioning: Number of Bouts and percent time in prone, reclined, supine, side-lying, seated, standing, and held.
Change in Parental Play Behaviors: Handling
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to Handling: Number of bouts and percent time with support by a container or parent at the head, upper trunk, lower trunk in prone, reclined, supine, side-lying, seated, standing, held positions.
Change in Parental Play Behaviors: Communication
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to communication: Communication: Number of words (total and number unique), babbling, style (fluctuation in pitch, responsiveness/turn-taking, gestures while communicating, labeling objects).
Change in Parental Play Behaviors: Toys
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
A Naturalistic Play Assessment during which we can observe parents' typical daily interaction with infants (i.e., parents are asked to go about their typical activities as if the experimenter were not there) through behavioral coding play sessions lasting 10-20 minutes. We will video code information related to toys: Frequency of toy use, number of unique toys, location of toys (Number of bouts and percent time in reach; Number of bouts and Percent time within-grasp).
Usability and Feasibility of the Intervention
Time frame: 1-month from start of study
The usability and feasibility of both interventions (Enriched Education and Typical Education) will be assessed using a Perception Questionnaire with 7-point Likert Scales (1= Completely Disagree; 7 = Completely Agree) including the meaningfulness and ease of use of the activities.
9 secondary outcomes
Change in Daily Positioning
Time frame: 2 days surrounding each of the 5 visits: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Infant Object Exploration
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Language Development
Time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Beliefs about Development
Time frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Knowledge about Development
Time frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parent Beliefs and Knowledge about Play
Time frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parenting Confidence
Time frame: Baseline (start of study), 1-month from start of study, 3-months from start of study, 6-months from start of study
Change in Parental Practices regarding Motor Development
Time frame: Baseline (start of study), 3-months from start of study, 6-months from start of study
Change in the Time of Achieving Developmental Milestones
Time frame: Reported at Baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (Typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)
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 16 May 2024.
- Individual participant dataSharing planned: Yes. A data sharing agreement is in place for the University of Delaware and the University of Chicago to share deidentified SPEAK-R and demographic data including: parent participant's age in years, highest level of school completed/highest degree obtained, race, and ethnicity age in years and highest level of school completed/highest degree obtained for other adult(s) living in the household, infant participant's race, ethnicity, and sex, and approximate total annual household income before taxes which the University of Chicago will use towards establishing the reliability of the SPEAK-R and publishing research articles.
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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.
Michele A Lobo, PT, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Education Program and Typical Education Program in people with Infant Development and Developmental Delay, run by University of Delaware 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 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 16 May 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?
Change in Infant Motor Development (time frame: Baseline (start of study), 1-month from start of study, 2-months from start of study, 3-months from start of study, 6-months from start of study). The study lists 7 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 16 May 2024.