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Implementation of Incredible Years for Autism and Language Delay Program in Spain

NCT04358484 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-02-08

No results posted yet for this study

Summary

Children with autism spectrum disorders (ASD) usually present coexisting problems in emotion and behavior regulation, similarly as premature children with communication or socialization difficulties. Caring for children with neurodevelopmental difficulties is an important stressor for parents. Therefore, it is essential that families are offered evidence-based interventions at an early stage within the public health service. Group therapy is a cost-effective intervention that can help parents of children diagnosed with autism and those born prematurely. The Incredible Years - ASLD program is an example of this sort of therapy, consisting of a group intervention for parents of preschool children with a diagnosis of ASD or Language Delay. In Spain, group interventions for children with ASD and preterm children presenting with Language Delay are scarce in the public health service. The Incredible Years - ASLD program has not been translated into Spanish and it has not been previously implemented in our country.

The Incredible Years - ASLD group intervention will be carried out in three public Healthcare centers. It is intended to recruit 72 patients diagnosed with ASD or premature children with communication or socialization difficulties, which will be randomized to an Intervention Group or to Treatment as Usual (TAU) Group. The Intervention Group will receive fourteen sessions of the Incredible Years - ASLD program in addition to Treatment as Usual (TAU). In terms of clinical implications, this randomized pilot study could demonstrate the feasibility of implementing this intervention in the regular clinical settings within the Spanish public health service and could be a first step for future controlled studies that demonstrate its effectiveness.

Conditions

Interventions

BEHAVIORAL

Incredible Years - ASD and Language Delay®

The IY - ASLD Program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age with symptoms or a diagnosis of ASD or delayed language acquisition. The program will be conducted by a therapist and a co-therapist, trained in the model. Fidelity to the intervention will be assessed in accordance with the regulations of the program. All of the therapists and co-therapists will be trained in the intervention by accredited trainers. The three main therapists will be supervised by accredited supervisors of the IY Program, seeking accreditation in the intervention. As the intervention IY - ASLD has not been translated into Spanish, the English materials will be used with simultaneous translation into Spanish language.

Sponsors & Collaborators

  • Fundació Sant Joan de Déu

    lead OTHER

Principal Investigators

  • Laia Villalta, Medicine · Fundació Sant Joan de Déu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358484 on ClinicalTrials.gov