Screening for Therapy and Empowering Parents: A Pilot Study

NCT04183504 | Completed

• 1 other identifier: 14-03212-XP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Primary Health Care

Keywords

Primary Health Care; Occupational Therapy; Child Development; Early Intervention; Parenting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Developmental screening results

  Through study completion, an average of 2 years.

• Number of referrals for early intervention or therapy services

  Through study completion, an average of 2 years.

• Follow through in obtaining early intervention or therapy services

  Through study completion, an average of 2 years.

Study Arms (1)

Early Steps Coaching

EXPERIMENTAL

Coaching session on positive parenting practices and promoting child development.

Behavioral: Brief parenting intervention

Interventions

Brief parenting intervention BEHAVIORAL

Coaching session on positive parenting practices and promoting child development

Early Steps Coaching

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (2)

Memphis Children's Clinic

Memphis, Tennessee, 38116, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (9)

• 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. doi: 10.1016/j.pedhc.2014.04.008. Epub 2014 Jun 11.

  PMID: 24929846 RESULT

• 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 developmental disorders in the medical home: an algorithm for developmental surveillance and screening. Pediatrics. 2006 Jul;118(1):405-20. doi: 10.1542/peds.2006-1231.

  PMID: 16818591 RESULT

• 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.

  PMID: 11581444 RESULT

• 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):e183-8. doi: 10.1542/peds.2006-0475.

  PMID: 16818532 RESULT

• 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.

  PMID: 11773555 RESULT

• 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 2012 Dec 17.

  PMID: 23248223 RESULT

• 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.

  PMID: 18504295 RESULT

• 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):e1178-86. doi: 10.1542/peds.2006-0466.

  PMID: 17015506 RESULT

• 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.

  PMID: 19171635 RESULT

Study Officials

• Anne H Zachry, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Occupational Therapy, Principle Investigator, Associate Professor

Model Details: One group pretest-posttest design

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2015
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately
• Access Criteria: Contact PI @ azachry@uthsc.edu

Locations

US (2)