Clinical trial NCT06790199: Implementation of a Teacher Classroom Program to Support Preschool Children with Autism or Developmental Problems
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Teacher Training
Teacher Skills in Addressing Child Mental Health Problem
Developmental Disorders
Keywords: Autism
Teacher training
Developmental disorders
Randomized controlled trial
Early intervention
Mental health
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2025-01-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, we aim to assess teachers' engagement, acceptability, and satisfaction with the program. Secondarily, we aim to gather preliminary evidence on the program's effectiveness in improving teachers' use of strategies, teacher self-efficacy, and in reducing burnout.

We will conduct an exploratory randomized controlled pilot trial. We aim to recruit approximately 40 teachers, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of teachers engaging with and finishing the program
timeFrame: Attendance sheet completed weekly throughout the intervention (6 weeks total)
measure: Compliance and satisfaction throughout the study (Incredible Years Teacher Weekly Evaluations)
timeFrame: Questionnaire administered to the intervention group weekly throughout the intervention (6 weeks total)
measure: Teachers' acceptability and satisfaction with the program (evaluated with the Final Participant Satisfaction Questionnaire)
timeFrame: Administered to the intervention group at intervention completion (approximately 6 weeks after baseline)
measure: Teachers' overall experiences with the program (evaluated with individual interviews)
timeFrame: Interviews to the participants of the intervention group at intervention completion (approximately 6 weeks after baseline)
measure: Group leaders' fidelity with the program (evaluated with the Leader Checklist)
timeFrame: Leader Checklist completed weekly throughout the intervention (6 weeks total)
measure: Clinicians' experiences with the intervention delivered (evaluated with individual interviews)
timeFrame: Interviews to clinicians at intervention completion (approximately 6 weeks after baseline)
Secondary outcomes:
measure: Changes from baseline to post-intervention in Teacher Strategies Questionnaire for Children with Autism (TSQ-A)
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
measure: Changes from baseline to post-intervention in Teacher Sense of Efficacy Scale-Long Version
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
measure: Changes from baseline to post-intervention in Maslach Burnout Inventory-Educators Survey
timeFrame: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Sant Joan de Deu
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.