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Completed

NCT Number: NCT06790199

Implementation of a Teacher Classroom Program to Support Preschool Children With Autism or Developmental Problems

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Percentage of teachers engaging with and finishing the program

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

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

Secondary outcomes

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

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

    The Teacher Strategies Questionnaire for Children with Autism (TSQ-A) is a 52-item teacher-report questionnaire part of the IY program materials that consists of six sections. The first section asks teachers to rate their confidence in promoting social, emotional, language and academic development of children with ASD. Sections 2-4 ask teachers to rate the frequency with which they use teaching techniques to support children's language, social and emotional development. In the last section, teachers rate the frequency of their planning and support strategies according to a five-point scale.

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

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

    The Teacher Sense of Efficacy Scale-Long Version (Tschannen-Moran & Hoy, 2001; Spanish version: Salas-Rodríguez et al., 2021) is a 24-item questionnaire that measures teachers' evaluations of how likely they are to be successful in teaching. Three different subscales are differentiated: efficacy for classroom management, efficacy to promote student engagement, and efficacy in using instructional strategies.

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

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

    The Maslach Burnout Inventory-Educators Survey (Maslach et al., 1986) is a version of the original Maslach Burnout Inventory for use with educators, including teachers, and has three scales that examine the three core aspects of burnout: emotional exhaustion (feelings of being emotionally overextended and exhausted by one's work), depersonalization (unfeeling and impersonal response toward recipients of one's instruction) and personal accomplishment (feelings of competence and successful achievement in one's work with students).

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Fundació La Marató de TV3

Registry information

Official study title

A Mixed-methods Evaluation of the Implementation of a Teacher Classroom Program to Support Preschool Children With Autism or Developmental Problems: A Feasibility Randomized Controlled Pilot Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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