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

NCT04358484 | Unknown

• 1 other identifier: PIC-220-19
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder; Language Delay; Prematurity

Keywords

Autism Spectrum Disorder; Language Delay; Prematurity; Incredible Years; Parenting Intervention

Outcome Measures

Primary Outcomes (4)

• Autism Program Parent Final Satisfaction Questionnaire

  Questionnaire for parents assessing their satisfaction with the IY-ASLD Program received.

  Administered to the intervention group at treatment completion (approximately 22 weeks after baseline).

• Register sheet of attendance

  Register of weekly attendance, aimed to determine levels of compliance with the intervention.

  Administered to the intervention group weekly throughout treatment (22 weeks total)

• Autism Program Parent Weekly Evaluation.

  Questionnaire assessing levels of satisfaction with each therapy session.This survey was specifically developed for the Incredible Years Program and can be found in the Incredible Years manual

  Administered to the intervention group weekly throughout treatment (22 weeks total)

• Incredible Years® Parent Strategies Questionnaire for Children with Autism (2-5 years)

  Questionnaire assessing type of parental strategies specifically aimed at helping children with ASD.

  Administered to the intervention group. Baseline (prior to programme initiation) and immediately after the intervention.

Secondary Outcomes (4)

• Parental Stress Index (PSI-SF) by Abidin.

  Administered to both arms.First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.

• Beck Depression Inventory (BDI)

  Administered to both arms. First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.

• Autism Specify Five Minutes Speech Sample - ASFMSS

  Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.

• Alabama Parenting Questionnaire Preschool revision (APQ-Pr).

  Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.

Other Outcomes (1)

• Child Behavior Checklist (CBCL11/2-5), Achenbach.

  Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants attend The Incredible Years - ASLD parenting intervention and continue to receive usual care at their healthcare center

Behavioral: Incredible Years - ASD and Language Delay®

Treatment As Usual (TAU) Group

NO INTERVENTION

Participants continue to receive usual care at their Healthcare Center

Interventions

Incredible Years - ASD and Language Delay® BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents who have signed the Informed Consent.
• Parents of children diagnosed with ASD.
• Parents of children between the ages of 2 and 5 years, 11months.
• Fluency in Spanish.
• Parents who have signed the informed consent.
• Parents of children born with gestational age less than 37 weeks.
• Parents of children with communication or socialization difficulties (Vineland-III scores 1SD below the mean in any of the communication or socialization subdomains).
• Parents of children between the ages of 2 and 5 years, 11months.
• Fluency in Spanish

You may not qualify if:

• Attending another structured/manualized parenting program (focused on improving strategies for parents to help their children with behavioral and emotion regulation) at the time of the study.
• Parents of looked after children.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Fundació Sant Joan de Déu

Esplugues de Llobregat, Spain

Location

Related Publications (1)

• Valencia F, Urbiola E, Romero-Gonzalez M, Navas I, Elias M, Garriz A, Ramirez A, Villalta L. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD(R) program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Trials. 2021 Apr 20;22(1):291. doi: 10.1186/s13063-021-05229-1.

  PMID: 33879224 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Language Development Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Laia Villalta, Medicine

  Fundació Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be recruited from three different sites across Spain: HSJD Barcelona, HGUGM Madrid and HMI Málaga. The first site will recruit parents of premature children and the other two sites will recruit parents of children diagnosed with ASD. Participants who meet inclusion criteria and sign the informed consent will complete a pre-intervention assessment. Families will be randomized to the intervention arm or to the treatment as usual (TAU) group, using stratified randomization regarding cognitive level. Those in the intervention arm will attend the IY-ASLD program and those in the TAU group will continue to receive usual care in their healthcare centers. Due to the COVID-19 pandemic the intervention has been postponed and there will be a re-assessment of parental stress and depressive symptoms in both groups just before starting the intervention. After the IY-ASLD is finished, participants in both groups will complete a post-intervention assessment.

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 24, 2020
• Study Start: January 2, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)