NCT06790199

Brief Summary

The Incredible Years® "Helping Preschool Children with Autism" (IY-HPCA) program is designed for teachers of children aged 2 to 5 years who have students with autism in their classrooms. The program provides tools to support children with autism. The primary aim of this pilot study is to examine the feasibility of implementing the IY-HPCA intervention among teachers of preschool children (typically aged 2 to 5 years) working in mainstream schools. Specifically, the study aims to assess teachers' engagement, acceptability, and satisfaction with the program. Secondarily, it aims to gather preliminary evidence on the program's effectiveness in improving teachers' use of strategies, teacher self-efficacy, and in reducing burnout. An exploratory randomized controlled pilot trial will be conducted. Approximately 40 teachers will be recruited, and they will be randomly assigned to either an intervention or control group. The intervention consists of six weekly sessions lasting 3 hours each, delivered by clinical psychologists and child psychiatrists specialized in developmental disorders at Hospital Sant Joan de Déu, in Barcelona. Two intervention face-to-face groups will be conducted at Hospital Sant Joan de Déu. Feasibility outcomes include program attendance, acceptability, and satisfaction (assessed using the Incredible Years Teacher Workshop Evaluations and the Teacher Satisfaction Questionnaire), as well as fidelity to the intervention delivery (measured with the Leader Checklist). After the intervention, individual interviews with teachers and group leaders will qualitatively assess satisfaction and experiences with the program. Secondary (effectiveness) outcomes include teachers' use of strategies (Teacher Strategies Questionnaire for Children with Autism), self-efficacy (Teacher Sense of Efficacy Scale), and burnout (Maslach Burnout Inventory-Educators Survey). This study will provide pioneering insights into the implementation of this program within the public mental health and education systems in Spain. This will allow the potential implementation of a wider randomized controlled trial in the future at a larger scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

January 17, 2025

Last Update Submit

April 22, 2026

Conditions

Keywords

AutismTeacher trainingDevelopmental disordersRandomized controlled trialEarly interventionMental health

Outcome Measures

Primary Outcomes (6)

  • Percentage of teachers engaging with and finishing the program

    Teachers' attendance at the sessions will be regeristered weekly with a sheet of attendance, with the aim to determine levels of compliance and engagement with the intervention. An attendance of at least 4/6 sessions is expected, with a minimum of 50% of teachers finishing the program.

    Attendance sheet completed weekly throughout the intervention (6 weeks total)

  • Compliance and satisfaction throughout the study (Incredible Years Teacher Weekly Evaluations)

    Teachers' compliance and satisfaction with the intervention will be assessed weekly after each session with the questionnaire "Incredible Years Teacher Weekly Evaluations", which is part of the IY-HPCA® program materials. This weekly assessment asks teachers to rate their satisfaction with different aspects of the program.

    Questionnaire administered to the intervention group weekly throughout the intervention (6 weeks total)

  • Teachers' acceptability and satisfaction with the program (evaluated with the Final Participant Satisfaction Questionnaire)

    Teachers' acceptability and satisfaction with the program will be assessed with the Final Participant Satisfaction Questionnaire-Helping Preschool Children with Autism Program (included within the IY-HPCA® program). Data will be collected after the last session of the intervention.

    Administered to the intervention group at intervention completion (approximately 6 weeks after baseline)

  • Teachers' overall experiences with the program (evaluated with individual interviews)

    Individual interviews will be conducted after the last session of the intervention to explore from a qualitative perspective: (1) teachers' acceptability, satisfaction and overall experience and perceptions of the intervention, and (2) teachers' perceived changes in their skills after the intervention. Outcome measurements 3 and 4 will be combined to determine teachers' experiences, acceptability and satisfaction with the program.

    Interviews to the participants of the intervention group at intervention completion (approximately 6 weeks after baseline)

  • Group leaders' fidelity with the program (evaluated with the Leader Checklist)

    Fidelity with the program will be assessed weekly after each session with the "Leader Checklist", which is part of the IY-HPCA® program materials. Group leaders (clinicians) will complete the Leader Checklist.

    Leader Checklist completed weekly throughout the intervention (6 weeks total)

  • Clinicians' experiences with the intervention delivered (evaluated with individual interviews)

    Individual interviews will be conducted after the last session with clinicians who delivered the intervention.

    Interviews to clinicians at intervention completion (approximately 6 weeks after baseline)

Secondary Outcomes (3)

  • Changes from baseline to post-intervention in Teacher Strategies Questionnaire for Children with Autism (TSQ-A)

    Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)

  • Changes from baseline to post-intervention in Teacher Sense of Efficacy Scale-Long Version

    Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)

  • Changes from baseline to post-intervention in Maslach Burnout Inventory-Educators Survey

    Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)

Study Arms (2)

Intervention group (Incredible Years-Helping Preschool Children with Autism program)

EXPERIMENTAL

Teachers in the intervention group will receive the Incredible Years-Helping Preschool Children with Autism program (IY-HPCA). They will participate in a 6-session group-based face-to-face intervention. Sessions will last 3 hours, will be delivered weekly at Hospital Sant Joan de Déu, and will be led by two trained co-leaders. The following main topics will be covered: (1) language development, (2) social interactions, and (3) emotion literacy and self-regulation. Two groups will be conducted, and each of them will include around 10 teachers.

Behavioral: Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA)

Control group

NO INTERVENTION

The control group will not receive the intervention. Teachers who are assigned to the control group will continue their usual teaching practice. No restrictions will be placed on schools regarding access to other training and support services during the course of the study, but this information will be monitored as a potential confounder. Teachers who are assigned to the intervention group will be asked not to share the intervention contents with other teachers who are in the control group before the end of the study.

Interventions

The IY-HPCA® program is a face-to-face 6-session group-based intervention for preschool teachers of children aged 2-5 with ASD or language and communication difficulties. Sessions last 3 hours, are delivered weekly, and are led by two trained co-leaders who have experience working with children on the autism spectrum. The program covers three main topics: (1) language development, (2) social interactions, and (3) emotion literacy and self-regulation. Teachers learn about coaching language, imitation, sensory routines, social communication, use of pretend and puppet play, and self-regulation skills. Visual supports such as picture schedules, choice cards, command and feelings cards are used, and practices are tailored to children's communication and play level stages. The intervention is structured and includes role-playing techniques and video visualization.

Intervention group (Incredible Years-Helping Preschool Children with Autism program)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teachers working at mainstream schools near the catchment area of Hospital Sant Joan de Déu Barcelona.
  • Teachers working at mainstream schools with specific programs for children with special needs.
  • Teachers of pre-school children.
  • Teachers willing to participate in the study and signing the inform consent.

You may not qualify if:

  • \- Teachers working at special education centers instead of mainstream schools.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (2)

  • Hayes R, Titheradge D, Allen K, Allwood M, Byford S, Edwards V, Hansford L, Longdon B, Norman S, Norwich B, Russell AE, Price A, Ukoumunne OC, Ford T. The Incredible Years(R) Teacher Classroom Management programme and its impact on teachers' professional self-efficacy, work-related stress, and general well-being: Results from the STARS randomized controlled trial. Br J Educ Psychol. 2020 May;90(2):330-348. doi: 10.1111/bjep.12284. Epub 2019 Apr 13.

    PMID: 30980389BACKGROUND
  • Serrano M, Elias M, Llorens M, Bolasell M, Vall-Roque H, Villalta L. Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial. Trials. 2024 Jul 20;25(1):496. doi: 10.1186/s13063-024-08278-4.

    PMID: 39033111BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderDevelopmental DisabilitiesAutistic DisorderPsychological Well-Being

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

November 25, 2024

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations