Clinical trial NCT06506097: Family-school Partnership Intervention for Early Childhood Education
Official title: Community-viable Family-school Partnership Intervention for Children With Social-communication Deficits in Early Childhood Education
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
preschool
Naturalistic Developmental Behavioral Intervention
education
parent
Lead sponsor: University of North Texas, Denton, TX
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-07-17
Enrollment: 110
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled (pre-post) clinical trial
Primary purpose: TREATMENT

Brief summary: Strategies for creating and maintaining reciprocal partnerships between teachers and parents are considered essential elements of developmentally appropriate practice in early childhood education (ECE). Particularly for children who are high-risk for behavioral, developmental, or mental health problems, effective partnerships between family and preschool are essential for promoting optimal classroom participation and learning outcomes. The current study is an uncontrolled (pre-post) feasibility trial of Family-School Partnership Intervention (FPSI). FSPI was developed using stakeholder input, is delivered by existing preschool staff, and aims to promote development and reduce barriers to learning among children with pre-clinical social-communication delays. FSPI integrates evidence-based practices (EBPs) from education (7 EBPs; National Association for the Education of Young Children) with clinical interventions for toddlers with autism spectrum disorder (ASD) (12 EBPs at the educator-parent level and 8 EBPs at the parent-child level; Naturalistic Developmental Behavioral Interventions). Data will be collected across 10 ECE programs. At each participating ECE program, research procedures will be completed during a single school year. Selected ECE programs will include public school, Head Start, and private preschool programs. Participants include 20 non-teaching support staff (1-2 per program; e.g., director, principal, education-coordinator), 30 lead teachers (2-4 per program), and 60 children with social-communication deficits (two per teacher). Data collection will focus on feasibility data (enrollment, attendance, attrition, data completion), observational measures of implementation fidelity (at the educator-parent and parent-child level), and mixed methods to evaluate educator and parent acceptability and satisfaction and identify implementation drivers/barriers. This research will prepare a large, multi-site hybrid trial to evaluate the effectiveness of FSPI for promoting social-communication skills and kindergarten readiness, in addition to factors that mediate the relation between FSPI delivery and fidelity (implementation drivers/barriers).


Eligibility criteria: Inclusion Criteria:

* currently attending classroom of participating preschool teacher.
* nominated by teacher as child with elevated levels of social-communication challenges

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Feasibility benchmark - Enrollment
timeFrame: Through study completion, an average of 1 year
measure: Feasibility benchmark - FSPI Completion
timeFrame: Through study completion, an average of 1 year
measure: Feasibility benchmark - Session Attendance
timeFrame: Through study completion, an average of 1 year
measure: Feasibility benchmark - Measure Completion
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denton
country: United States
facility: UNT
state: Texas
Study officials:
References: