Gross Motor Development DelayNCT06139549
The Effects of Playful Pathways
An observational study of Gross Motor Development Delay, run by Arkansas Colleges of Health Education at 1 site in United States.
Trial summary
The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gross Motor Development Delay
- What is being tested?
- Gross motor development group session
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 20 Feb 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants ages 0-6 months Caregivers age 18 and older
Who may be able to join
- 1. All babies typically developing or any diagnosis ages 0 - 6 months
- At least 18 years of age
- Able to communicate in and read English
- Parent/caregiver of baby ages 0 - 6 months who is participating in the program
- Ability to provide transportation to/from research site(s)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arkansas Colleges of Health Education
Fort Smith, Arkansas, 72916
Allison N Young, DPT, 479-401-6029, allison.young@achehealth.edu
About this study
Official title: The Effects of Playful Pathways, a Play-Based Developmentally Focused Group Program, and How it Affects Caregivers' Health Literacy and Self-Efficacy and Influences Outcomes for Infants
The purpose of this study is to evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. The researchers aim to screen and identify developmental delays and the effects of the 8 week program on gross motor development as well as explore parent perceptions of the program.
The aim of this study is to assess the physical, social, and emotional outcomes of an interactive group program for infants 0-6 months and their families/caregiver.
- Conditions
- Gross Motor Development Delay
- Being tested
- Gross motor development group session
- Keywords
- INFANT, GROSS MOTOR DEVELOPMENT, GROUP SESSION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross motor development group sessionOther
Group session for gross motor development
What is being measured
The primary outcome is the main question the study is designed to answer.
DAYC-2
measure of gross motor development
Measured: 9/20/23 - 2/20/24
PHLAT-8
measure of health literacy
Measured: 9/20/23 - 2/20/24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Sep 2023
- Primary completion8 Nov 2023 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gross Motor Development DelayStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Colleges of Health Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Young, Arkansas Colleges of Health Education
- Investigators
- Allison N Young, DPT, Principal investigator, Arkansas Colleges of Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139549
- Sponsor's protocol ID
- ACHEFALL2023PP
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alkhazrajy, L. A., & Aldeen, E. R. S. (2017). Assessment of mothers knowledge regarding the developmental milestone among children under two years in Iraq. American Journal of Applied Sciences, 14(9), 869-877.
Aoyama T, Hikihara Y, Watanabe M, Wakabayashi H, Hanawa S, Omi N, Takimoto H, Tanaka S. Association Between Age of Achieving Gross Motor Development Milestones During Infancy and Body Fat Percentage at 6 to 7 Years of Age. Matern Child Health J. 2022 Feb;26(2):415-423. doi: 10.1007/s10995-021-03238-9. Epub 2021 Oct 16.
PubMed 34655425
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Playful Pathways, a Play-Based Developmentally Focused Group Program, and How it Affects Caregivers' Health Literacy and Self-Efficacy and Influences Outcomes for Infants
- ClinicalTrials.gov ID
- NCT06139549
- Acronym / sponsor ID
- ACHEFALL2023PP
- Conditions
- Gross Motor Development Delay
- Keywords
- INFANT, GROSS MOTOR DEVELOPMENT, GROUP SESSION
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Arkansas Colleges of Health EducationUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 8 Nov 2023 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 18 Nov 2023 (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 evaluate infants ages 0-6 months of age before and after an 8 week developmental and educational "caregiver and baby" interactive program as well as 3 month following the conclusion of the program. The researchers aim to screen and identify developmental delays and the effects of the 8 week program on gross motor development as well as explore parent perceptions of the program.
The aim of this study is to assess the physical, social, and emotional outcomes of an interactive group program for infants 0-6 months and their families/caregiver.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants ages 0-6 months Caregivers age 18 and older
Key inclusion criteria (5 listed)
- 1. All babies typically developing or any diagnosis ages 0 - 6 months
- At least 18 years of age
- Able to communicate in and read English
- Parent/caregiver of baby ages 0 - 6 months who is participating in the program
- Ability to provide transportation to/from research site(s)
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 |
|---|---|---|
| Gross motor development group sessionGroup session for gross motor development | Other | – |
Primary outcome
DAYC-2
Time frame: 9/20/23 - 2/20/24
measure of gross motor development
PHLAT-8
Time frame: 9/20/23 - 2/20/24
measure of health literacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publicationAlkhazrajy, L. A., & Aldeen, E. R. S. (2017). Assessment of mothers knowledge regarding the developmental milestone among children under two years in Iraq. American Journal of Applied Sciences, 14(9), 869-877.
- Results publication: PubMed 34655425Aoyama T, Hikihara Y, Watanabe M, Wakabayashi H, Hanawa S, Omi N, Takimoto H, Tanaka S. Association Between Age of Achieving Gross Motor Development Milestones During Infancy and Body Fat Percentage at 6 to 7 Years of Age. Matern Child Health J. 2022 Feb;26(2):415-423. doi: 10.1007/s10995-021-03238-9. Epub 2021 Oct 16.
- Individual participant dataSharing planned: No
Related trials for Gross Motor Development Delay
RecruitingObservational study
Vestibular and Postural Function in Children Suspected of Balance Disorders
Children, Only, Vestibular Disorder
Enrolling by invitation
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Cerebral Palsy, Myelomeningocele
Recruiting
Effect of Task Specific Electrical Stimulation on Upper Limb Gross Motor Skills in Children With Spastic Quadriplegia
Cerebral Palsy (CP), Spastic Cerebral Palsy
Active, not recruiting
Grand Valley State University (GVSU) Skills on Wheels
Spina Bifida, Cerebral Palsy
RecruitingObservational study
Video-based Assessment of Preschool Children's Gross Motor Development
Gross Motor Development Delay
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.
Allison N Young, DPT principal investigator
Arkansas Colleges of Health Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gross Motor Development Delay, run by Arkansas Colleges of Health Education 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 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LaVona Traywick, PHD (4794016023, lavona.traywick@achehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAYC-2 (time frame: 9/20/23 - 2/20/24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06139549, which also lists 2 linked publications.
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 Nov 2023.