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Completed

NCT Number: NCT06692946

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Parent-Training

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alessandra Carta, Sassari, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cooperative Parent-Mediated therapy

Behavioral

Parent-mediated therapy is an intervention where parents are trained to use therapeutic techniques to support their child's development and manage symptoms, often used for conditions like autism spectrum disorder (ASD).

Other names: Parent-child training

Treatement as Usual

Behavioral

Cognitive Behavioral Therapy (CBT) is a structured, short-term psychological treatment that focuses on identifying and changing negative thought patterns and behaviors. It aims to help individuals develop healthier ways of thinking and coping with challenges by addressing both cognitive (thought) and behavioral components.

Parent training is an educational intervention where parents learn strategies and techniques to effectively manage their child's behavior and support their development, often used to address challenges associated with conditions like autism or ADHD.

Other names: Cognitive Behavioral therapy and Traditional Parent Training

Primary outcomes

  1. parent-child interaction assessed by the PICCOLO scale.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ALESSANDRA CARTA

Other

Collaborators

  • Bambino Gesù Children's Hospital IRCCS

Registry information

Official study 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

Acronym: C-PMT in ASD

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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