- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06506097
Family-school Partnership Intervention for Early Childhood Education
Community-viable Family-school Partnership Intervention for Children With Social-communication Deficits in Early Childhood Education
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Siller, PhD
- Phone Number: 8505677474
- Email: michael.siller@unt.edu
Study Locations
-
-
Texas
-
Denton, Texas, United States, 76203
- Recruiting
- UNT
-
Contact:
- Michael Siller, PhD
- Phone Number: 9405654596
- Email: Megan.Lukanuski@unt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family-school Partnership Intervention (FSPI)
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility benchmark - Enrollment
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student-Teacher Relationship Scale
Time Frame: baseline, exit
|
The STRS is rated by teachers (Pianta, 1992; 15 items) and provides subscales for closeness and conflict.
|
baseline, exit
|
|
Child-Parent Relationship Scale
Time Frame: baseline, exit
|
The CPRS is rated by parents (Driscoll & Pianta, 2011; 15 items) and provides subscales for closeness and conflict.
|
baseline, exit
|
|
Parent-Teacher Relationship Scale
Time Frame: baseline, exit
|
The PTRS is rated by both parents and teachers (Vickers & Minke, 1995; 24 items) and provides five subscales: (1) affiliation & support, (2) dependability & availability, (3) shared expectations & beliefs, (4) sharing of emotions, and (5) sharing of information.
|
baseline, exit
|
|
Social Skills Improvement System-Social Emotional Learning Edition-Rating Form
Time Frame: baseline, exit
|
The SSIS-SEL Edition RF (Gresham & Elliot, 2017; 58 items) is rated by teachers.
It is a normed measure aligned with the Collaborative for Academic, Social, and Emotional Learning framework (CASEL, 2013).
|
baseline, exit
|
|
Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure
Time Frame: exit only
|
These three measures (AIM, IAM, FIM; Weiner et al., 2017; 12-items total) are rated by parents, teachers, and non-teaching staff.
They evaluate feasibility, acceptability, and appropriateness benchmarks using a brief battery of implementation measures.
Scores range from 1 to 5, and the benchmark will be set at >3.5 (scores of 3 and 4 correspond to "neither agree nor disagree" and "agree").
|
exit only
|
|
Observational coding of child active engagement and parent/teacher implementation fidelity
Time Frame: throughout the intervention period (at each intervention session)
|
These will be coded from video-recorded FSPI Playgroup recordings using observational measures derived from the Naturalistic Developmental Behavioral Intervention (NDBI) framework (Edmunds et al., 2022).
|
throughout the intervention period (at each intervention session)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7R21HD105168-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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