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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06692946
Acronym
C-PMT in ASD
Enrollment
50
Registered
2024-11-18
Start date
2021-09-01
Completion date
2024-01-18
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Parent-Training

Keywords

Neurodevelopmental disorders, Parent-child interaction, Community Healthcare service, Additional therapeutic effects

Brief summary

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.

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.

Interventions

BEHAVIORALCooperative 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).

BEHAVIORALTreatement 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.

Sponsors

Bambino Gesù Children's Hospital IRCCS
CollaboratorOTHER
ALESSANDRA CARTA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Assessments were not conducted by a blinded independent assessor

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
parent-child interaction assessed by the PICCOLO scale.Up to 12monthsparent-child interaction is video recorded and trained observers code-specific parenting behaviors known to predict children's early social, cognitive, and language development.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026