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Sponsor study identifier
interventional
14
1 country
1
Study Start
May 17, 2017
Actual (reported)Primary Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Fragile X Syndrome (FXS) and Williams-Beuren Syndrome (WBS) are relatively rare disorders characterized by developmental delay associated to socio-communicative deficit and autistic-like behaviours. WBS has been considered for a long time as the "polar opposite" of ASD, given their hypersociable phenotype. Nonetheless, recent researches have emphasized similarities between ASD and WBS phenotypes. By following some authors "social abnormalities in ASD and WS can be characterized in terms of analogous difficulties in social cognition), and distinct patterns of social motivation which appears to be reduced in ASD and enhanced in WBS". More than opposite condition, these authors suggests that WBS and ASD could share the same difficult in comprehension of social relationship, with opposite pattern of social engagement (enhanced in WBS and weakened ASD). Given, these similarities authors suggest testing the feasibility and validity of therapy for ASD in children with WBS. Parent Mediated Therapy (PMT) is a group of "technique-focused interventions where the parent is the agent of change and the child is the direct beneficiary of treatment". PMT demonstrated evidence of effectiveness in socio-communicational improvement for children with ASD in a randomized controlled trial (RCT). Some recent researchers have extended the use of PMT to children with genetic disorders and autistic features, such as FXS. While showing encouraging results, the samples of research were limited. They main aim of this research is to to verify effectiveness of Cooperative PMT (CMPT) for socio-communicative deficit in children with FXS and WBS. Our hypothesis is that CPMT, in addition to conventional rehabilitation therapies (mainly speech therapy and occupational therapies), could contribute to the enhancement of socio-communicative skills and the reduction of behavioural problems. We also expected also an improvement in family quality of life and a reduction of parental stress.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2017
Actual (reported)October 8, 2020
Actual (reported)October 30, 2020
Actual (reported)June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Joint attention
Joint attention score from ESCS assessment. Score expressed in percentage of behavior/number of occasion (from 0% to 100%). Higher scores indicate better functioning
6 months
Assertivity
Assertivity as measured by Skills Socio-Conversational of the Child. Scores from 1 to 5 (Higher scores indicate better functioning)
6 months
Responsivity
Assertivity as measured by Skills Socio-Conversational of the Child. Scores from 1 to 5 (Higher scores indicate better functioning)
6 months
Expressive language (Word)
Expressive language as measured by word production scale of Primo vocabolario del bambino (from 0 to 408). higher raw scores indicate higher level of language
6 months
Expressive language (Gestures)
Expressive language as measured by gestures production scale of Primo vocabolario del bambino (from 0 to 63). higher raw scores indicate higher level of language
6 months
Behavioral and emotional problem
6 months
Change in Adaptive Level (Vineland Adaptive Behavior Scales, Second Edition)
6 months
Clinical improvement: Clinical Global Impression - Severity scale
6 months
Clinical Global Impression - Improvement scale (CGI-I)
6 months
Cognitive/developmental Level
6 months
Cooperative Parent Mediated Therapy" (CPMT) is a targeted parent-mediated intervention focused on the ASD core symptoms (Bearss et al., 2015). CPMT is based on the most significant models of parent training for ASD, in the perspective of Naturalistic Developmental Behavioral Interventions-NDBI with specific attention to the promotion of cooperative interactions (Schreibman et al., 2016). The aim of CPMT is to improve parental skills, to enable parents promoting the following seven target skills in their child: socio-emotional engagement, emotional regulation, imitation, communication, joint attention, play and cognitive flexibility and cooperative interaction. An individualized treatment plan is designed for each child in order to determine his developmental level and treatment goals (Valeri et al., 2019).
Control group
CMPT usually last 6 months, for a total amount of 15 sessions of 90 min; twelve core sessions (one session per week) are delivered in the first 3 months, followed by 3 monthly booster sessions. Each weekly core session had a specific focus and specific intervention strategies based on active parent coaching during parent-child interaction, and included the parent-child dyad with the parent being actively coached by a trained therapist. Live active coaching increases parents' competence in implementing strategies to enhance child development, and at the same time increases their confidence. This intervention has demonstrated evidence of effectiveness in socio-communicational improvement as measured by ADOS-G (Valeri, 2019) in a randomized controlled trial (RCT).
Ospedale Pediatrico Bambino Gesù
Roma, 00146, Italy
Paolo Alfieri, PhD, MD
Ospedale Pediatrico Bambino Gesù
First Submitted
October 8, 2020
First Posted
October 30, 2020
Study Start
May 17, 2017
Actual (reported)Primary Completion
June 2021
Estimated (date passed)Receptive Language (Word)
Receptive language as measured word comprehension scale of Primo vocabolario del bambino (from 0 to 408). higher raw scores indicate higher level of language
6 months
Receptive Language (Sentences)
Receptive language as measured by sentence comprehension scale of Primo vocabolario del bambino (from 0 to 28). higher raw scores indicate higher level of language
6 months
Speech Language Therapy and Occuapational Therapy provided as usual by National Health Services
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 30, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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