Pilot randomized clinical trial implementation of a parenting program in Spanish children with autism in special education schools
| ISRCTN | ISRCTN75231331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75231331 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IY-ASLD-SCHOOL |
| Sponsor | Hospital General Universitario Gregorio Marañón |
| Funder | Fundación Alicia Koplowitz |
- Submission date
- 24/09/2025
- Registration date
- 15/12/2025
- Last edited
- 22/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Autism Spectrum Disorder (ASD) is characterized by impairments in communication, social interaction, and the presence of repetitive behaviors, frequently accompanied by comorbid conditions such as epilepsy, gastrointestinal disturbances, and emotional dysregulation. These challenges extend to the mental health of caregivers, particularly parents. Evidence-based early interventions, including structured parent training programs, have demonstrated efficacy in enhancing family well-being. The IY-ASLD® program, validated in international contexts, aims to mitigate behavioral issues in children with ASD. Despite its proven effectiveness, implementation in Spain remains limited. Special education settings are proposed as optimal environments for deployment.
The first phase of this study aims to evaluate the feasibility of implementing the IY-ASLD® program in a special needs school. In a second phase of the study, we aim to explore evidence of effectiveness and preliminary cost-effectiveness of the IY-ASLD® program in parents of children with ASD, aged 2-5, who are enrolled in a special education school in Madrid.
Who can participate?
Parents or legal guardians of patients between 2 and 5 years-old diagnosed with ASD
What does the study involve?
This project will consist on two phases:
In an initial phase, a pilot feasibility study will be conducted to evaluate the feasibility of implementing a parenting program for parents of children with ASD in special education schools. This study will be carried out following the guidelines for the design and evaluation of pilot and feasibility studies.
In a second phase, and if the results of the pilot study are satisfactory, a pragmatic, randomized, controlled clinical trial comprising a 14-week intervention with a 12-month follow-up period, will be conducted to evaluate the effectiveness of implementing this parenting program for parents of children with ASD in special education schools.
Participating families will be randomly allocated to the intervention group (the IY-ASLD® program) or to the control group receiving the standard care in special education on a 1:1 ratio.
Assessment points for both the feasibility and the clinical trial will comprise baseline, directly after the end of treatment (post-treatment), and follow-ups 6 and 12 months post-treatment.
What are the possible benefits and risks of participating?
There are no risks associated with participating in this study. Some fatigue may occur after completing the questionnaires. Participation will not result in direct personal benefit. However, altruistically, participants will contribute to a better understanding of the effects of a parenting program aimed at preventing socio-emotional difficulties in children with ASD
Where is the study run from?
Hospital General Universitario Gregorio Marañón in Madrid, Spain
When is the study starting and how long is it expected to run for?
The study is starting on March 2025 and is expected to run for 2 years, until December 2027
Who is funding the study?
This study is funded by the Alicia Koplowitz Foundation (Spain)
Who is the main contact?
Laura Sevilla Cermeño, lauramaria.sevilla@salud.madrid.org
Contact information
Public, Scientific, Principal investigator
Calle Ibiza 43
Madrid
28009
Spain
 ORCID ID |
0000-0002-6471-0402 |
|---|---|
| Phone | +34 669592256 |
| lauramaria.sevilla@salud.madrid.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A (first phase) pilot feasibility study and a (second phase) pragmatic randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 48056 PIS 3-Hoja de Información y consentimiento IY-ASLDS.pdf |
| Scientific title | Protocol for a pilot randomized clinical trial: implementation of the Incredible Years-ASLD® program in Spanish children with autism in special education schools |
| Study acronym | IY-ASLD-SCHOOL |
| Study objectives | The first phase of this study aims to evaluate the feasibility of implementing The Incredible Years® Autism Spectrum and Language Delays program (IY-ASLD) in a special needs school. In a second phase of the study, we aim to explore evidence of effectiveness and preliminary cost-effectiveness of the IY-ASLD program in parents of children with ASD, aged 2-5, who are enrolled in a special education school in Madrid. Specific objectives are: 1. To measure the intervention´s fidelity, acceptability and satisfaction 2. To explore the effect of the program on parental strategies of children with ASD, on parental depressive and stress symptoms, and on parental quality of life. 3. To examine the program´s impact on the core symptomatology of ASD and on the internalising and externalising symptomatology of children with ASD, whose parents receive the intervention. |
| Ethics approval(s) |
Approved 11/02/2025, Research Ethics Committee on Medicinal Products of the Gregorio Marañón Hospital (C/ Dr. Esquerdo 46, Madrid, 28007, Spain; +34 (0)91 586 7007; ceim.hgugm@salud.madrid.org), ref: Y-ASLD-SCHOOL |
| Health condition(s) or problem(s) studied | Prevention of of behavioral problems and other psychopathology (anxiety, hyperactivity, or social difficulties) in children diagnosed with Autism Spectrum Disorder. |
| Intervention | The intervention consists of weekly 2-hour sessions over a 14-week period. The program includes home-based activities that parents/legal guardians are expected to complete and each family will receive a weekly phone call to encourage and support them in completing these tasks. Each parent group may include up to 14 parents. The program focuses on promoting healthy parent-child relationships, providing parents with behavioral management tools, and encouraging adaptive behaviors in children, among other goals. It emphasizes the importance of practice-based learning through role-playing. The program will be delivered by experienced mental health professionals specifically certified according to the IY-ASLD® program standards. This accreditation includes support from certified supervisors during the initial weeks of program implementation. Both the official training and accreditation, as well as the initial supervision, are conducted online. The Spanish-translated and validated version of the program will be used. Control group: The control group will receive standard care in special education. This standard intervention consists of individualized attention to the specific needs of the students, promoting learning in areas such as communication and language, personal autonomy, social skills, and knowledge of the environment. This intervention involves the coordinated work of an interdisciplinary team, which, together with families, offers a comprehensive approach and prepares the students for the transition to compulsory basic education. Families allocated to the intervention group will also receive standard care in special education. Randomization will be conducted after completion of the baseline assessment and signing of the informed consent. Families will be randomly assigned to one of two arms: the intervention group or the control group. As this is a pragmatic clinical trial, randomization will be carried out under the usual conditions of the participating schools, and potential external variables that may influence outcomes will be considered in the statistical analysis. Data analyses will be performed using SPSS version 29.0 and R version 4.3.1. An independent researcher will perform the randomization process. Researchers involved in patient recruitment or intervention delivery will not participate in the allocation procedure. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Sociodemographic variables (Family structure, age of the parents and the child, child's sex, ethnicity, medical comorbidities and psychiatric diagnoses, age at ASD diagnosis and location where it was made, financial aid received, current psychotropic pharmacological treatments, school grade, behavioral treatments previously or currently received, and psychiatric disorders in siblings (if any) ) measured using a questionnaire ar baseline |
| Key secondary outcome measure(s) |
1. The preliminary effectiveness of IY-ASLD® program measured using the ASD-P Parenting Strategies Questionnaire, the Patient Health Questionnaire-9, the Parenting Stress Inventory-Short Form, the Social Communication Questionnaire, the Adaptive Behavior Assessment System, the Autism Impact Measure, the Child Behavior Checklist at baseline, post-intervention, 6 and 12 months of follow-up |
| Completion date | 30/12/2027 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Key inclusion criteria | 1. Parents or legal guardians of patients diagnosed with ASD (clinical diagnosis by a psychiatrist or clinical psychologist from the Madrid Health Service, according to DSM-5 diagnostic criteria). 2. Children aged between 2 and 5 years of age (inclusive) at the time of the baseline assessment. 3. Patients must be enrolled in one of the special education schools included in the HGUGM mental health liaison program. 4. Parents must have a high level of knowledge and understanding of the Spanish language. 5. Informed consent for the study must be signed by the minors’ parents or legal representatives. |
| Key exclusion criteria | 1. Receiving another intervention from a structured parenting program during the intervention phase of this study. 2. Refusal to sign the informed consent form 3. Guardianship or custody of the child by the authorities at the time of the intervention. |
| Date of first enrolment | 12/03/2025 |
| Date of final enrolment | 30/06/2027 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28009
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Spanish | 26/09/2025 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
Editorial Notes
24/09/2025: Trial's existence confirmed by Research Ethics Committee on Medicinal Products of the Gregorio Marañón Hospital.
