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

A

ALESSANDRA CARTA

Status

Completed

Conditions

Autism Spectrum Disorder
Parent-Training

Treatments

Behavioral: Cooperative Parent-Mediated therapy
Behavioral: Treatement as Usual

Study type

Interventional

Funder types

Other

Identifiers

NCT06692946
2021-0545 (Other Identifier)
Prot. PG/2022/18028

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

2 to 10 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

Treatment As Usual (TAU)-Control group
Placebo Comparator group
Description:
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).
Treatment:
Behavioral: Treatement as Usual
Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy
Experimental group
Description:
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)
Treatment:
Behavioral: Treatement as Usual
Behavioral: Cooperative Parent-Mediated therapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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