Clinical trial NCT06692946: Clinical Efficacy of Cooperative Parent-Mediated Therapy (C-PMT_in_ASD)
Official title: Evaluation of the Clinical Efficacy of Cooperative Parent-Mediated Therapy (Cooperative-PMT) in Preschool and School-Aged Children With ASD Within the "Autism in Re.Te: Let's Not Leave Them Alone" - Social Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Parent-Training
Keywords: Neurodevelopmental disorders
Parent-child interaction
Community Healthcare service
Additional therapeutic effects
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Bambino Gesù Children's Hospital IRCCS
First posted: 2024-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A rater-blinded RCT conducted in an Italian Child Neuropsychiatry community service. The study included two groups: the experimental CPMT group where children and parents receiving both CPMT and TAU and TAU-CG, where children received only individual PI.
Primary purpose: TREATMENT

Brief summary: The research highlights the lack of studies assessing the effectiveness of evidence-based interventions for ASD in community services. This RCT study aims to evaluate the effectiveness of Cooperative Parent Mediated Therapy (CPMT), a parent coaching program previously shown to be effective in tertiary care settings.

Detailed description: Fifty participants with ASD (aged 2-10 years) and their parents were randomized into two groups: both groups received treatment as usual (TAU), but only the experimental group participated in CPMT. The primary outcomes indicated significant improvements in parent-child interaction and benefits in adaptive skills, ASD symptom severity, and parental stress levels in the CPMT group, whereas the TAU group showed no notable changes. The study suggests that the CPMT model is effective in community healthcare settings, representing a significant advancement for ASD therapy.

Eligibility criteria: Inclusion Criteria:

* age between 2 and 10 years;
* clinical diagnosis of ASD based on DSM-5 criteria ;
* scores above the autism spectrum cut-off on the Autism Diagnostic Observation Schedule Generic-ADOS-2 ;

Exclusion Criteria:

* 2 years \> age \< 10 years;
* not received clinical diagnosi for ASD in line with DSM-5 criteria;
* absence of other major medical diagnoses (i.e., epilepsy, genetic syndromes);
* absence of psychosocial treatment during the trial.

Primary outcomes:
measure: parent-child interaction assessed by the PICCOLO scale.
timeFrame: Up to 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Alessandra Carta
city: Sassari
country: Italy
facility: Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari
Study officials:
References:
citation: Scattoni ML, Fatta LM, Micai M, Sali ME, Bellomo M, Salvitti T, Fulceri F, Castellano A, Molteni M, Gambino G, Posada M, Romano G, Puopolo M. Autism spectrum disorder prevalence in Italy: a nationwide study promoted by the Ministry of Health. Child Adolesc Psychiatry Ment Health. 2023 Oct 28;17(1):125. doi: 10.1186/s13034-023-00673-0.
citation: Autism spectrum disorder in under 19s: support and management. London: National Institute for Health and Care Excellence (NICE); 2021 Jun 14. Available from http://www.ncbi.nlm.nih.gov/books/NBK571989/
citation: Oono IP, Honey EJ, McConachie H. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009774. doi: 10.1002/14651858.CD009774.pub2.
citation: Valeri G, Casula L, Menghini D, Amendola FA, Napoli E, Pasqualetti P, Vicari S. Cooperative parent-mediated therapy for Italian preschool children with autism spectrum disorder: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2020 Jul;29(7):935-946. doi: 10.1007/s00787-019-01395-5. Epub 2019 Sep 23.