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Recruiting NCT06506097

Family-school Partnership Intervention for Early Childhood Education

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Family-school Partnership Intervention (FSPI).
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 2 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Community-viable Family-school Partnership Intervention for Children With Social-communication Deficits in Early Childhood Education

Overview

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).

Interventions

  • Behavioral Family-school Partnership Intervention (FSPI)
    FSPI includes implementation activities across multiple levels. FSPI Planning Team Meetings will be held monthly to plan project activities, practice staff and parent coaching strategies, and troubleshoot implementation challenges. FSPI Staff Training (3 hours) will be provided during a single professional development day (3 hours), and attended by members of the FSPI Planning Team and teachers. FSPI Playgroups. Over the course of the school year, each parent-child dyad will be invited to par

Primary outcome measures

  • Feasibility benchmark - Enrollment [Time frame: Through study completion, an average of 1 year]
  • Feasibility benchmark - FSPI Completion [Time frame: Through study completion, an average of 1 year]
  • Feasibility benchmark - Session Attendance [Time frame: Through study completion, an average of 1 year]
  • Feasibility benchmark - Measure Completion [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
  • Student-Teacher Relationship Scale [Time frame: baseline, exit]
  • Child-Parent Relationship Scale [Time frame: baseline, exit]
  • Parent-Teacher Relationship Scale [Time frame: baseline, exit]
  • Social Skills Improvement System-Social Emotional Learning Edition-Rating Form [Time frame: baseline, exit]
  • Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure [Time frame: exit only]
  • Observational coding of child active engagement and parent/teacher implementation fidelity [Time frame: throughout the intervention period (at each intervention session)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UNT — Denton

Identifiers

NCT: NCT06506097 · 7R21HD105168-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗