Effectiveness of a Parent-mediated Intervention With PACT on Children With ASD

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Preschool Autism Communication Therapy (PACT)
* Other: Treatment As Usual (TAU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: a group of children receiving the usual therapy (TAU)<br>Children will receive therapies available in the community as speech language therapist or occupational therapist. | Other: Treatment As Usual (TAU)<br>* Children will receive therapies available in the community as speech language therapist or occupational therapist.<br>|
| Experimental: a group of children receiving TAU plus the PACT intervention.<br>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. | Other: Preschool Autism Communication Therapy (PACT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism symptoms | Autism symptoms measured with ADOS-2 ( Autism Spectrum Observation Schedule version 2) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 and 12 months | 
| Parent-child synchrony and initiative in communication | Parent-child synchrony and initiative in communication measure with DCMA (Dyadic Communication Measure for autism) | 6 and 12 months | 
| 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) | 12 months | 
| 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) | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interventions Early Start Denver Model (ESDM), Preschool Autism Communication Therapy (PACT)