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

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

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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