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

NCT06692946 | Completed DMC

• 2 other identifiers: Prot. PG/2022/180282021-0545
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder; Parent-Training

Keywords

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

Outcome Measures

Primary Outcomes (1)

• parent-child interaction assessed by the PICCOLO scale.

  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

Study Arms (2)

Treatment As Usual (TAU)-Control group

PLACEBO COMPARATOR

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

Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy

EXPERIMENTAL

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

Interventions

Cooperative Parent-Mediated therapy 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).

Also known as: Parent-child training

Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy

Treatement as Usual 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.

Also known as: Cognitive Behavioral therapy and Traditional Parent Training

Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy; Treatment As Usual (TAU)-Control group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 ;

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALESSANDRA CARTA: lead
• Bambino Gesù Children's Hospital IRCCS: collaborator

Study Sites (2)

Alessandra Carta

Sassari, 07100, Italy

Location

Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari

Sassari, 07100, Italy

Location

Related Publications (4)

• Scattoni ML, Fatta LM, Micai M, Sali ME, Bellomo M, Salvitti T, Fulceri F, Castellano A, Molteni M, Gambino G, Posada M, Romano G, Puopolo M. Autism spectrum disorder prevalence in Italy: a nationwide study promoted by the Ministry of Health. Child Adolesc Psychiatry Ment Health. 2023 Oct 28;17(1):125. doi: 10.1186/s13034-023-00673-0.

  PMID: 37898807 RESULT

• Autism spectrum disorder in under 19s: support and management. London: National Institute for Health and Care Excellence (NICE); 2021 Jun 14. Available from http://www.ncbi.nlm.nih.gov/books/NBK571989/

  PMID: 34283415 RESULT

• Oono IP, Honey EJ, McConachie H. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009774. doi: 10.1002/14651858.CD009774.pub2.

  PMID: 23633377 RESULT

• Valeri G, Casula L, Menghini D, Amendola FA, Napoli E, Pasqualetti P, Vicari S. Cooperative parent-mediated therapy for Italian preschool children with autism spectrum disorder: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2020 Jul;29(7):935-946. doi: 10.1007/s00787-019-01395-5. Epub 2019 Sep 23.

  PMID: 31549310 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments were not conducted by a blinded independent assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 18, 2024
• Study Start: September 1, 2021
• Primary Completion: December 20, 2023
• Study Completion: January 18, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)