Clinical Efficacy of Cooperative Parent-Mediated Therapy (C-PMT_in

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-01-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Parent-Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Assessments were not conducted by a blinded independent assessor

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Treatement as Usual

Intervention Type 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.

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)

Group Type EXPERIMENTAL

Cooperative Parent-Mediated therapy

Intervention Type 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).

Treatement as Usual

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Parent-child training Cognitive Behavioral therapy and Traditional Parent Training

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No