Primary Health Care Clinical Trial
Official title:
Early STEPs: Screening for Therapy and Empowering Parents: A Pilot Study
Verified date | May 2023 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is expand on the Early STEPs project goal of identifying early developmental delays in infants and young children in a health disparate population and to collect preliminary data to lay the groundwork for a future NIH grant proposal. Individuals with less education have poor health and shorter life expectancies than well-educated individuals, and research reveals that poverty is directly related to limited education. An innovative approach is needed to overcome barriers, improve health literacy, and educate parents on effective parenting strategies for this population. Technology may be the part of the solution to this issue. Through Early STEPs, the occupational therapists will continue to refer families to early intervention and therapy services as appropriate and follow-up to ensure that services are initiated. The Occupational Therapist will also determine if the parents are utilizing the Word Gap App and other provided resources to support their child's development and to manage their stress. By increasing parental awareness and knowledge of language and motor skill development, the environments of underserved children will be enriched and parental stress will be reduced so that these children can have improved health and reach their full potential.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 7, 2018 |
Est. primary completion date | May 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 7 Years |
Eligibility | Inclusion Criteria: - parent provides written informed consent to take part in the study - child has no congenital malformations or genetic syndromes - child is not enrolled in Early Intervention Services. - child is not in foster care - Parent agrees to attend parent training session - Parent agrees to complete pre- and post- Parenting Sense of Competence scale - Child is between birth and 6 years 11 months 29 days Exclusion Criteria - Parent will not signed informed consent. - child has congenital malformations or genetic syndrome - child is not enrolled in Early Intervention Services. - child is in foster care - child is 7 years or older |
Country | Name | City | State |
---|---|---|---|
United States | Memphis Children's Clinic | Memphis | Tennessee |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee |
United States,
Berry AD, Garzon DL, Mack P, Kanwischer KZ, Beck DG. Implementing an early childhood developmental screening and surveillance program in primary care settings: lessons learned from a project in Illinois. J Pediatr Health Care. 2014 Nov-Dec;28(6):516-25. d — View Citation
Council on Children With Disabilities; Section on Developmental Behavioral Pediatrics; Bright Futures Steering Committee; Medical Home Initiatives for Children With Special Needs Project Advisory Committee. Identifying infants and young children with deve — View Citation
Dobrez D, Sasso AL, Holl J, Shalowitz M, Leon S, Budetti P. Estimating the cost of developmental and behavioral screening of preschool children in general pediatric practice. Pediatrics. 2001 Oct;108(4):913-22. doi: 10.1542/peds.108.4.913. — View Citation
Earls MF, Hay SS. Setting the stage for success: implementation of developmental and behavioral screening and surveillance in primary care practice--the North Carolina Assuring Better Child Health and Development (ABCD) Project. Pediatrics. 2006 Jul;118(1 — View Citation
Frankenburg WK. Developmental surveillance and screening of infants and young children. Pediatrics. 2002 Jan;109(1):144-5. doi: 10.1542/peds.109.1.144. No abstract available. — View Citation
Guevara JP, Gerdes M, Localio R, Huang YV, Pinto-Martin J, Minkovitz CS, Hsu D, Kyriakou L, Baglivo S, Kavanagh J, Pati S. Effectiveness of developmental screening in an urban setting. Pediatrics. 2013 Jan;131(1):30-7. doi: 10.1542/peds.2012-0765. Epub 20 — View Citation
Rosenberg SA, Zhang D, Robinson CC. Prevalence of developmental delays and participation in early intervention services for young children. Pediatrics. 2008 Jun;121(6):e1503-9. doi: 10.1542/peds.2007-1680. Epub 2008 May 26. — View Citation
Rydz D, Srour M, Oskoui M, Marget N, Shiller M, Birnbaum R, Majnemer A, Shevell MI. Screening for developmental delay in the setting of a community pediatric clinic: a prospective assessment of parent-report questionnaires. Pediatrics. 2006 Oct;118(4):e11 — View Citation
Schonwald A, Huntington N, Chan E, Risko W, Bridgemohan C. Routine developmental screening implemented in urban primary care settings: more evidence of feasibility and effectiveness. Pediatrics. 2009 Feb;123(2):660-8. doi: 10.1542/peds.2007-2798. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parenting Sense of Competence Scale | Parenting Sense of Competence Scale- Scores range from 9 to 54, with higher scores indicating greater parenting satisfaction. | Through study completion, an average of 2 years. | |
Secondary | Developmental screening results | Ages & Stages Questionniare03 (ASQ-3TM), parental report questionnaire that provides scores for each of the following domains: communication, gross motor, fine motor, problem- solving, and personal/social skills. Every version of the screening includes specific cutoff scores to indicate if child's development is on schedule or not. The cutoff scores vary from one age level to the next, ranging from 0 to 60, with 60 indicating a higher developmental level. | Through study completion, an average of 2 years. | |
Secondary | Number of referrals for early intervention or therapy services | Actual number of referrals made to early intervention services or therapy. | Through study completion, an average of 2 years. | |
Secondary | Follow through in obtaining early intervention or therapy services | Counts for each type of service obtained: early intervention, occupational therapy, physical therapy, speech therapy, or comprehensive developmental evaluation | Through study completion, an average of 2 years. |
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