Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Autism Spectrum Disorder
  • Language Delay
  • Prematurity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 2471 years
Gender
Both males and females

Description

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3. Premature infants are at particular risk for neurodevelopmental disturbances, such as language delay, difficulties in social commun...

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3. Premature infants are at particular risk for neurodevelopmental disturbances, such as language delay, difficulties in social communication and ASD. ASD is often associated with behavior difficulties, emotion regulation difficulties, psychiatric comorbidities and a dysfunctional response to sensory stimuli. Children with premature birth also present difficulties related to emotion and behavior regulation. Due to these difficulties, caring for children with neurodevelopmental disorders can be very stressful for parents, which could in turn lead to lower effectiveness of interventions and greater mental health difficulties in parents. Therefore, parenting interventions should not only address children's difficulties, these interventions should also aim to provide support for parents. Since no interventions have specifically addressed these two aspects in the treatment of neurodevelopmental disorders, several therapies have been adapted for this population. This is the case of the intervention at hand: Incredible Years - ASD and Language Delay (IY-ASLD). In this intervention, in addition to learning strategies to promote the development of skills in children, parents receive support from other parents and from the therapists. The effectiveness of the Incredible Years program has been widely demonstrated in multiple randomized clinical trials, showing an improvement in terms of parental stress levels, depression and parental coping, as well as in children behavior difficulties. Incredible Years is also considered an evidence-based intervention according to the NICE guidelines. The Incredible Years Program has been adapted for parents of children between ages 2 and 5 diagnosed with ASD, presenting ASD symptoms or language delay. A pilot study conducted in the UK has demonstrated high levels of acceptability, as well as a decrease in levels of parental stress associated with the care of their children. The results of a pilot randomized clinical trial in Wales have been recently published, supporting the feasibility of this intervention in the NHS and showing good levels of acceptability and fidelity to the program and compliance. The Incredible Years - ASLD Program has not been implemented in Spain and to the best of our knowledge it has not been used with parents of children of premature birth with communication and socialization difficulties. This study aims to demonstrate the feasibility of reliably implementing the IY-ASLD parental program in different outpatient services of the Spanish public health service, as well as exploring its effectiveness in terms of reducing parental distress and improving children outcomes. The IY - ASLD program will be implemented in three sites across Spain: Hospital Sant Joan de Déu Barcelona (HSJD), Hospital General Universitario Gregorio Marañón (HGUGM) and Hospital Materno Infantil (HMI) de Málaga. In the first site the program will be implemented with parents of premature children with communication and socialization impairment, and in the other two sites the program will be applied with parents of children diagnosed with ASD. The IY-ASLD program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age. The sessions will be conducted by a therapist and a co-therapist, both trained in the program. A total of n = 72 parents (48 with ASD children and 24 with premature children) will be recruited and will be randomized to a control group (36 parents: 24 with ASD children and 12 with premature children) or group intervention (36 parents: 24 with ASD children and 12 with premature children).

Tracking Information

NCT #
NCT04358484
Collaborators
Not Provided
Investigators
Principal Investigator: Laia Villalta, Medicine Fundació Sant Joan de Déu