Autism Spectrum DisorderC-PMT in ASDNCT06692946
Clinical Efficacy of Cooperative Parent-Mediated Therapy (C-PMT_in_ASD)
A study testing Cooperative Parent-Mediated therapy and Treatement as Usual in people with Autism Spectrum Disorder and Parent-Training, run by ALESSANDRA CARTA at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder, Parent-Training
- What is being tested?
- Cooperative Parent-Mediated therapy and Treatement as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2021to 18 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 ;
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
Alessandra Carta
Sassari, 07100
Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari
Sassari, 07100
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Parent-Training
- Being tested
- Cooperative Parent-Mediated therapy, Treatement as Usual
- Keywords
- Neurodevelopmental disorders, Parent-child interaction, Community Healthcare service, Additional therapeutic effects
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooperative Parent-Mediated therapyBehavioural
Also called Parent-child training
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 UsualBehavioural
Also called Cognitive Behavioral therapy and Traditional Parent Training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Behavioral: Cooperative Parent-Mediated therapy; Behavioral: Treatement as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Sep 2021
- Primary completion20 Dec 2023
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALESSANDRA CARTA
- Sponsor type
- University, hospital or other
- Collaborators
- Bambino Gesù Children's Hospital IRCCS
- Responsible party
- Sponsor-investigator, ALESSANDRA CARTA, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692946
- Sponsor's protocol ID
- Prot. PG/2022/18028
- Other IDs
- 2021-0545
- Acronym
- C-PMT in ASD
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be shared with other researchers upon specific request and with prior approval from the Ethics Committee.
Publications
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.
PubMed 37898807Autism 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/
PubMed 34283415Oono 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.
PubMed 23633377Valeri 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.
PubMed 31549310
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06692946
- Acronym / sponsor ID
- C-PMT in ASD / Prot. PG/2022/18028
- Conditions
- Autism Spectrum Disorder, Parent-Training
- Keywords
- Neurodevelopmental disorders, Parent-child interaction, Community Healthcare service, Additional therapeutic effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ALESSANDRA CARTAUniversity, hospital or other
- Collaborators
- Bambino Gesù Children's Hospital IRCCS
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU)-Control group | Placebo comparator | Behavioral: Treatement as Usual25 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). |
| Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy | Experimental | Behavioral: Cooperative Parent-Mediated therapy, Behavioral: Treatement as UsualChildren 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) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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 ;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooperative Parent-Mediated therapyAlso: Parent-child trainingParent-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). | Behavioural | Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy |
| Treatement as UsualAlso: Cognitive Behavioral therapy and Traditional Parent TrainingCognitive 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. | Behavioural | Experimental Group: Cooperative parent mediated therapy and Cognitive Behavioural therapy, Treatment As Usual (TAU)-Control group |
Primary outcome
parent-child interaction assessed by the PICCOLO scale.
Time frame: Up to 12months
parent-child interaction is video recorded and trained observers code-specific parenting behaviors known to predict children's early social, cognitive, and language development.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Results publication: PubMed 37898807Scattoni 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.
- Results publication: PubMed 34283415Autism 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/
- Results publication: PubMed 23633377Oono 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.
- Results publication: PubMed 31549310Valeri 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.
- Individual participant dataSharing planned: No. Individual participant data may be shared with other researchers upon specific request and with prior approval from the Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooperative Parent-Mediated therapy and Treatement as Usual in people with Autism Spectrum Disorder and Parent-Training, run by ALESSANDRA CARTA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parent-child interaction assessed by the PICCOLO scale. (time frame: Up to 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06692946, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.