Back to resultsEffectiveness of a Parent-mediated Intervention With PACT on Children With ASD (iPACT)
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Preschool Autism Communication Therapy (PACT)
Treatment As Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring interventions Early Start Denver Model (ESDM), Preschool Autism Communication Therapy (PACT)
Eligibility Criteria
Inclusion Criteria:
Child with autism Spectrum disorder
- Symptoms in autism with a severity superior to 4 as measure by ADOS-2
- Positive ADI (Autism Diagnostic Interview)
- Diagnostic done by a multidisciplinary team
- Nonverbal IQ above 12 months Live more than 40 min from a Center for resources in autism -Parents speaking French Having health assurance
Exclusion Criteria:
For the child
- Child with a twin brother or sister with ASD or having a brother or sister already included in this study
- Epilepsy requiring medication
- Severe hearing or visual impairment
- Identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis)
For the parents
- Severe hearing or visual impairment
- Severe psychiatric disorder
- Unstable somatic disorders preventing intervention
- Lack of Internet access
- Parent not available for regular follow-up
- Opposition of one parent to the child's participation in a study
Sites / Locations
- Hopital VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
a group of children receiving the usual therapy (TAU)
a group of children receiving TAU plus the PACT intervention.
Arm Description
Children will receive therapies available in the community as speech language therapist or occupational therapist.
Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child.
Outcomes
Primary Outcome Measures
Autism symptoms
Autism symptoms measured with ADOS-2 ( Autism Spectrum Observation Schedule version 2)
Secondary Outcome Measures
Social Interactions of the child
Social Interactions measured with the total score of the BOSCC (Brief Observation of Social Communication Change).
The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behavior, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behavior, and anxious behaviors. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms.
Parent-child synchrony and initiative in communication
Parent-child synchrony and initiative in communication measure with DCMA (Dyadic Communication Measure for autism)
Number of words produced by the child
Number of words produced by the child measured with global score of the french scale " Développement du Langage de Production en Français " (DLPF)
Number of words produced by the child
Number of words produced by the child measured with global score of the Mullen Scale of early learning (MSEL)
Adaptative behavior
Adaptative behavior measured with VABS (Vineland Adaptative Behaviour Scales 2).
The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
Autism Family Experience
Measured with the questionnaire Autism Family Experience. The Autism Family Experience Questionnaire (AFEQ) is a parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. The AFEQ included both positively and negatively worded statements and is scored on an order scale: 1 = always to 5 = never, with an option for "Not Applicable". 4 domains are evaluated : experience of being a parent, family life, child development understanding and social relationships, child symptoms.A higher score means a worse outcome.
Characteristics of the parents
Measured with General Health Questionnaire (GHQ-28). The GHQ-28 is a 28-item self-report used to psychological stress. The GHQ focuses on two main classes of phenomena: 1) inability to carry out one's normal healthy functions; and 2) emergence of new phenomena that are distressing.
It consists of 28 items, divided into 4 sub-scales. It contains 4 sub-scales: A (somatic symptoms), B (anxiety/insomnia), C (social dysfunction), and D (severe depression). There are 4 possible answers to each question. The Likert scoring system assigns a value from 0 to 3 to each of the 4 possible answers. A higher score means a worse outcome.
Characteristics of the parents
Measured with ISP (Indice of Parental Stress). A self-report inventory designed to measure the overall level of parenting stress an individual is experiencing and it examine stressors associated specifically with the parental role and do not include stresses associated with other life roles and events. The PSI-SR has strong psychometric properties and has been used in a number of studies of autism and parent training. It contains 36 items, each rated on a five-point Likert scale (1-5), with higher scores indicative of more parenting stress and includes Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC) sub-scales.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04244721
Brief Title
Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD
Acronym
iPACT
Official Title
Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.
Detailed Description
In PACT, parents are guided, generally in face to face, by a professional to improve the synchrony and communication with their children with ASD. Then, it is recommended to the parents to practice the therapy daily at home. In France, this type of early intervention is poorly developed and is only accessible in specialized centers located in large urban centers. Guiding parents by videoconferencing could make this intervention accessible to families in undeserved areas. The objective of this study is to evaluate the effectiveness of a PACT intervention delivered by parents and guided by videoconferencing, on the autism in their children with ASD, aged 18 to 36 months at the inclusion.
This study is a multicenter (5 centers), two-parallel-group, randomised controlled trial. It will compare a group of children receiving the usual therapy (TAU) and a group receiving TAU plus the PACT intervention. The primary outcome is the autism symptoms measured with the ADOS-2 (Autism Diagnostic Observation Schedule) at 12 months. A total of 238 children will be included in the study (119 per group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
interventions Early Start Denver Model (ESDM), Preschool Autism Communication Therapy (PACT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To make the comparison between the two groups on autism symptoms outcome measured with ADOS-2, with a power of 80% and an improvement of 0.6 points, we need 198 children (99 per group). After taking into account of a 20% consensual withdrawals and poor compliance with PACT, 238 children (119 per group) will be required. Each center will therefore have to include 50 children during the inclusion period.
Masking
Participant
Masking Description
To make the comparison between the two groups on autism symptoms outcome measured with ADOS-2, with a power of 80% and an improvement of 0.6 points, we need 198 children (99 per group). After taking into account of a 20% consensual withdrawals and poor compliance with PACT, 238 children (119 per group) will be required. Each center will therefore have to include 50 children during the inclusion period.
Allocation
Randomized
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a group of children receiving the usual therapy (TAU)
Arm Type
Sham Comparator
Arm Description
Children will receive therapies available in the community as speech language therapist or occupational therapist.
Arm Title
a group of children receiving TAU plus the PACT intervention.
Arm Type
Experimental
Arm Description
Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child.
Intervention Type
Other
Intervention Name(s)
Preschool Autism Communication Therapy (PACT)
Intervention Description
Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual (TAU)
Intervention Description
Children will receive therapies available in the community as speech language therapist or occupational therapist.
Primary Outcome Measure Information:
Title
Autism symptoms
Description
Autism symptoms measured with ADOS-2 ( Autism Spectrum Observation Schedule version 2)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Social Interactions of the child
Description
Social Interactions measured with the total score of the BOSCC (Brief Observation of Social Communication Change).
The test contains 9 items that are meant to capture the quality of a child's social interaction, for which the total scores ranges from 0 to 45, and 3 items describing restricted a repetitive behavior, which is also part of the ASD symptomatology, the total score of which ranges from 0 to 15. Three additional items are coded to add information on symptoms that might be present although they are not specifically part of the ASD syndrome, and refer to activity level, disruptive behavior, and anxious behaviors. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms.
Time Frame
6 and 12 months
Title
Parent-child synchrony and initiative in communication
Description
Parent-child synchrony and initiative in communication measure with DCMA (Dyadic Communication Measure for autism)
Time Frame
6 and 12 months
Title
Number of words produced by the child
Description
Number of words produced by the child measured with global score of the french scale " Développement du Langage de Production en Français " (DLPF)
Time Frame
12 months
Title
Number of words produced by the child
Description
Number of words produced by the child measured with global score of the Mullen Scale of early learning (MSEL)
Time Frame
12 months
Title
Adaptative behavior
Description
Adaptative behavior measured with VABS (Vineland Adaptative Behaviour Scales 2).
The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
Time Frame
12 months
Title
Autism Family Experience
Description
Measured with the questionnaire Autism Family Experience. The Autism Family Experience Questionnaire (AFEQ) is a parent/Caregiver form used to measure impact of autism interventions on family experience and quality of life. The AFEQ included both positively and negatively worded statements and is scored on an order scale: 1 = always to 5 = never, with an option for "Not Applicable". 4 domains are evaluated : experience of being a parent, family life, child development understanding and social relationships, child symptoms.A higher score means a worse outcome.
Time Frame
12 months
Title
Characteristics of the parents
Description
Measured with General Health Questionnaire (GHQ-28). The GHQ-28 is a 28-item self-report used to psychological stress. The GHQ focuses on two main classes of phenomena: 1) inability to carry out one's normal healthy functions; and 2) emergence of new phenomena that are distressing.
It consists of 28 items, divided into 4 sub-scales. It contains 4 sub-scales: A (somatic symptoms), B (anxiety/insomnia), C (social dysfunction), and D (severe depression). There are 4 possible answers to each question. The Likert scoring system assigns a value from 0 to 3 to each of the 4 possible answers. A higher score means a worse outcome.
Time Frame
12 months
Title
Characteristics of the parents
Description
Measured with ISP (Indice of Parental Stress). A self-report inventory designed to measure the overall level of parenting stress an individual is experiencing and it examine stressors associated specifically with the parental role and do not include stresses associated with other life roles and events. The PSI-SR has strong psychometric properties and has been used in a number of studies of autism and parent training. It contains 36 items, each rated on a five-point Likert scale (1-5), with higher scores indicative of more parenting stress and includes Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC) sub-scales.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child with autism Spectrum disorder
Symptoms in autism with a severity superior to 4 as measure by ADOS-2
Positive ADI (Autism Diagnostic Interview)
Diagnostic done by a multidisciplinary team
Nonverbal IQ above 12 months Live more than 40 min from a Center for resources in autism -Parents speaking French Having health assurance
Exclusion Criteria:
For the child
Child with a twin brother or sister with ASD or having a brother or sister already included in this study
Epilepsy requiring medication
Severe hearing or visual impairment
Identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis)
For the parents
Severe hearing or visual impairment
Severe psychiatric disorder
Unstable somatic disorders preventing intervention
Lack of Internet access
Parent not available for regular follow-up
Opposition of one parent to the child's participation in a study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydie SARTELET
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Facility Information:
Facility Name
Hopital Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GEOFFRAY Marie-Maude, PhD
Phone
+33 (0)4 72 75 53 24
Email
marie-maude.geoffray@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Sandrine TOUZET
Phone
04 72 11 51 62
Ext
+33
Email
sandrine.touzet@chu-lyon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33827837
Citation
Jurek L, Occelli P, Denis A, Amestoy A, Maffre T, Dauchez T, Oreve MJ, Baghdadli A, Schroder C, Jay A, Zelmar A, Revah-Levy A, Gallifet N, Aldred C, Garg S, Green J, Touzet S, Geoffray MM; IFPAD study group. Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol. BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.
Results Reference
derived
Learn more about this trial
Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD
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