NCT06506097

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

June 14, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

June 14, 2024

Last Update Submit

February 12, 2026

Conditions

Keywords

autismpreschoolNaturalistic Developmental Behavioral Interventioneducationparent

Outcome Measures

Primary Outcomes (4)

  • Feasibility benchmark - Enrollment

    Throughout we will collect administrative data on enrollment. Data will be judged against pre-specified feasibility criteria: Enrollment (20 non-teaching staff, 30 teachers, 60 parents) will meet 100% of target.

    Through study completion, an average of 1 year

  • Feasibility benchmark - FSPI Completion

    Throughout we will collect administrative data on attrition. Data will be judged against pre-specified feasibility criteria: % of parents completing the intervention. Benchmarks: \>80% for FSPI completion, \>75% for session attendance (parents), and \>80% for measure completion (staff, parents).

    Through study completion, an average of 1 year

  • Feasibility benchmark - Session Attendance

    Throughout we will collect administrative data on session attendance. Data will be judged against pre-specified feasibility criteria: % of sessions completed by preschool staff and parents. Benchmarks: \>75% for session attendance.

    Through study completion, an average of 1 year

  • Feasibility benchmark - Measure Completion

    Throughout we will collect administrative data on data collection components. Data will be judged against pre-specified feasibility criteria: % of measures completed by preschool staff and parents: Benchmarks: \>80%.

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • Student-Teacher Relationship Scale

    baseline, exit

  • Child-Parent Relationship Scale

    baseline, exit

  • Parent-Teacher Relationship Scale

    baseline, exit

  • Social Skills Improvement System-Social Emotional Learning Edition-Rating Form

    baseline, exit

  • Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure

    exit only

  • +1 more secondary outcomes

Study Arms (1)

Family-school Partnership Intervention (FSPI)

EXPERIMENTAL

Participants include 20 non-teaching support staff (1-2 per program), 30 lead teachers (2-4 per program), and 60 children with social-communication deficits (two per teacher). FSPI creates new opportunities for teachers to partner with families, particularly parents of children with social-communication vulnerabilities. Specifically, teachers will be provided with a curriculum, training, and resources to engage two families from their classroom in three FSPI Playgroup meetings, scheduled over the course of the current school year. During each playgroup, teaches will help parents practice simple strategies for promoting communication during familiar routines such as play, book reading, preparing a snack, or completing a simple chore.

Behavioral: Family-school Partnership Intervention (FSPI)

Interventions

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 participate in three FSPI Playgroup events. Typically, teachers from two classrooms will collaborate in hosting playgroup events, and each playgroup will be attended by four parent-child dyads (i.e., two per classroom). Teachers will be provided with a curriculum and learning outcomes to target. FSPI Debrief Meetings are held after each FSPI Playgroup to debrief, reflect, and improve FSPI implementation.

Family-school Partnership Intervention (FSPI)

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNT

Denton, Texas, 76203, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Michael Siller, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Uncontrolled (pre-post) clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 14, 2024

First Posted

July 17, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations