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Pilot randomized clinical trial implementation of a parenting program in Spanish children with autism in special education schools

Protocol for a pilot randomized clinical trial: implementation of the Incredible Years-ASLD® program in Spanish children with autism in special education schools

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75231331
Enrollment
70
Registered
2025-12-15
Start date
2025-03-12
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of of behavioral problems and other psychopathology (anxiety, hyperactivity, or social difficulties) in children diagnosed with Autism Spectrum Disorder. Mental and Behavioural Disorders

Interventions

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

Sponsors

Hospital General Universitario Gregorio Marañón
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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 2. The socioeconomic status of the family unit measured using the Hollingshead-Rendlich scale at baseline 3. Program fidelity and participant retention measured by registering participant attendance to sessions and percentage of participants who complete evaluations at baseline, post-intervention, 6 and 12 months of follow-up 4 Feasibility of implementing IY-ASLD® program in special education measured by a weekly parental evaluation and a final parental satisfaction questionnaire of the IY-ASLD® program at post-intervention, 6 and 12 months of follow-up

Secondary

MeasureTime frame
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 2. The cost-effectiveness of the intervention measured by a brief cost diary including the costs of training to develop the IY-ASLD® parenting program and the costs associated with its implementation (materials, team members’ work hours etc.) and by the EQ-5D-Y scale and the Client Sociodemographic and Service Receipt Inventory at post-intervention, 6 and 12 months of follow-up

Countries

Spain

Contacts

Public ContactLaura María Sevilla Cermeño
lauramaria.sevilla@salud.madrid.org+34 669592256

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026