An interventional study of Brief parenting intervention in Primary Health Care, sponsored by University of Tennessee. Completed at 2 sites in United States. Open to participants aged Up to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by University of Tennessee · Not applicable, Interventional, and Supportive care
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.
Rationale: Research has consistently shown that providing timely early intervention (EI) services for young children identified as developmentally delayed improves both short-term and long-term outcomes. It is critical that children with delays be identified as early as possible because intervention programs are more effective when initiated at a young age. In fact, the American Academy of Pediatrics (AAP) advocates identifying delays before children reach 2 years of age.
There is evidence that primary care providers tend to under-detect developmental delays among infants and young children. In addition, in high poverty areas, transportation, finances and other logistical challenges often prevent parents of young children from regularly visiting a physician, which further contributes to limited opportunities for intervention.
Under-enrollment in intervention programs has been identified as a national problem, one that is recognized as a critical issue in the Mid-South due to the lower percentage of young children being identified and referred for services. Nationally, it is estimated that 16-18% of children have disabilities; however, less than one-third of these cases are referred for intervention before kindergarten age. Besides the issue of under-identification of developmental problems in young children, research suggests that many children who are referred for Early Intervention services do not end up receiving therapy due to poor follow-through by caregivers. It is likely that families need support and guidance regarding the importance of Early Intervention services.
Unaddressed developmental delays can negatively impact the future health and educational attainment of our nation's infants. Families benefit from screening through an increased awareness of appropriate developmental and behavioral expectations. For example, screening can lead to positive outcomes in family interaction and decreased parental stress levels when developmental information and recommendations for activities are provided, even for children who do not fully meet the criteria to be referred. In the Memphis area, enrollment of children under the age of 3 in EI programs has actually decreased over the past five years, despite strong evidence that the incidence of disabilities such as autism is on the rise. Nationally, 2.52% of young children receive EI services; in Tennessee, 1.8% of children are receiving services needed.
Research Design: To determine the effectiveness of the Early STEPs project, investigators will compare pre- and post-project referrals for EI services, follow through by families, and pre and post parental satisfaction qualitative data. The participating pediatric practices will provide documentation of their prior average number of monthly early intervention referrals and this information will be compared to the monthly number of referrals at the end of the study period. The investigators will follow-up with the parent of the referred child at 6- and 12-months to determine if early intervention services were initiated by the parent and to determine if the parents perceived that the developmental app and online support group were helpful and improved confidence with their parenting skills.
The data collection will begin on February 3, 2014 and end in approximately 2 years.
Outcome Measures: The PI will monitor and report on:
University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Coaching session on positive parenting practices and promoting child development.
Behavioral: Brief parenting intervention
Coaching session on positive parenting practices and promoting child development
Parenting Sense of Competence Scale
Parenting Sense of Competence Scale- Scores range from 9 to 54, with higher scores indicating greater parenting satisfaction.
Time frame: Through study completion, an average of 2 years.
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.
Time frame: Through study completion, an average of 2 years.
Number of referrals for early intervention or therapy services
Actual number of referrals made to early intervention services or therapy.
Time frame: Through study completion, an average of 2 years.
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
Time frame: Through study completion, an average of 2 years.
Plan to share: Yes — Study protocol, Statistical Analysis Plan, Informed Consent Form
Supporting information: Study protocol, Sap
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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