Clinical Efficacy of Cooperative Parent-Mediated Therapy (C-PMT_in_ASD)

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Parent-Training

• Registration Number: NCT06692946
• Lead Sponsor: ALESSANDRA CARTA

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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2023-12-20
• Study Completion: 2024-01-18
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
parent-child interaction assessed by the PICCOLO scale.	Up to 12months	parent-child interaction is video recorded and trained observers code-specific parenting behaviors known to predict children's early social, cognitive, and language development.

Trial Locations

Locations (2)

Alessandra Carta; 🇮🇹 Sassari, Italy

Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari; 🇮🇹 Sassari, Italy