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

November 15, 2024 updated by: ALESSANDRA CARTA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Sassari, Italy, 07100
        • Alessandra Carta
      • Sassari, Italy, 07100
        • Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Treatment As Usual (TAU)-Control group
25 children were randomly assigned to the TAU control group, stratified by cognitive level (IQ or DQ < 70) and language impairment (verbal /non-verbal patients). They undergo Traditional treatement for ASD (CBT and PT).
Behavioral: Treatement as Usual

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
Experimental: Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy

Children were randomly assigned to the experimental group, stratified by cognitive level (IQ or DQ < 70) and language impairment (verbal /non-verbal patients).

The experimental group consists in 25 children exposed to Cooperative Parent Mediated Therapy as an add on treatment to the TAU (CBT and PT)
Behavioral: Treatement as Usual

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
Behavioral: Cooperative Parent-Mediated therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALESSANDRA CARTA

Collaborators

Bambino Gesù Children's Hospital IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. PG/2022/18028
  • 2021-0545 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data may be shared with other researchers upon specific request and with prior approval from the Ethics Committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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