Autism Spectrum DisorderNCT06506097
Family-school Partnership Intervention for Early Childhood Education
A study testing Family-school Partnership Intervention (FSPI) in people with Autism Spectrum Disorder, run by University of North Texas, Denton, TX at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Family-school Partnership Intervention (FSPI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- currently attending classroom of participating preschool teacher.
- nominated by teacher as child with elevated levels of social-communication challenges
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNT
Denton, Texas, 76203
Michael Siller, PhD, 9405654596, Megan.Lukanuski@unt.edu
About this study
Official title: Community-viable Family-school Partnership Intervention for Children With Social-communication Deficits in Early Childhood Education
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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Family-school Partnership Intervention (FSPI)
- Keywords
- autism, preschool, Naturalistic Developmental Behavioral Intervention, education, parent
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-school Partnership Intervention (FSPI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family-school Partnership Intervention (FSPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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%.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Student-Teacher Relationship Scale
The STRS is rated by teachers (Pianta, 1992; 15 items) and provides subscales for closeness and conflict.
Measured: baseline, exit
Child-Parent Relationship Scale
The CPRS is rated by parents (Driscoll \& Pianta, 2011; 15 items) and provides subscales for closeness and conflict.
Measured: baseline, exit
Parent-Teacher Relationship Scale
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.
Measured: baseline, exit
Social Skills Improvement System-Social Emotional Learning Edition-Rating Form
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).
Measured: baseline, exit
Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure
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").
Measured: exit only
Observational coding of child active engagement and parent/teacher implementation fidelity
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).
Measured: throughout the intervention period (at each intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled (pre-post) clinical trial
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Texas, Denton, TX
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michael Siller, University of North Texas, Denton, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506097
- Sponsor's protocol ID
- 7R21HD105168-02
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-viable Family-school Partnership Intervention for Children With Social-communication Deficits in Early Childhood Education
- ClinicalTrials.gov ID
- NCT06506097
- Acronym / sponsor ID
- 7R21HD105168-02
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, preschool, Naturalistic Developmental Behavioral Intervention, education, parent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University of North Texas, Denton, TXUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled (pre-post) clinical trial
| Arm | Type | Receives |
|---|---|---|
| Family-school Partnership Intervention (FSPI) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- currently attending classroom of participating preschool teacher.
- nominated by teacher as child with elevated levels of social-communication challenges
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Behavioural | Family-school Partnership Intervention (FSPI) |
Primary outcome
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.
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).
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.
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%.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-school Partnership Intervention (FSPI) in people with Autism Spectrum Disorder, run by University of North Texas, Denton, TX at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Siller, PhD (8505677474, michael.siller@unt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility benchmark - Enrollment (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.