Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder

Study Overview
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Brief Summary
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Paediatric Autism Communication Therapy (PACT) is a naturalistic developmental behavioural interventions to reduce autism symptoms. The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of autism spectrum disorder.

Detailed Description
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Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting approximately 2% of children and young people worldwide. ASD is considered a lifelong disorder and interventions significantly reducing the core autistic symptoms have been sparse. Paediatric Autism Communication Therapy (PACT) is among the first naturalistic developmental behavioural interventions to show promising results for reduction in autism symptoms. The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of ASD. This trial is an investigator-initiated, independently funded, pragmatic, national, parallel group, superiority, randomised clinical trial comparing PACT combined with management as usual to management as usual alone.

Official Title
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Paediatric Autism Communication Therapy (PACT) Combined With Management as Usual Compared to Management as Usual Alone in Children With Autism Spectrum Disorder - a Pragmatic, National, Randomised Clinical Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: PACT
* Behavioral: MAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 2 through 6 years (both inclusive) A diagnosis of ASD meeting the criteria for International Classification of Diseases; Tenth Edition (ICD-10): Diagnose codes: DF84.0, DF84.1, DF84.5, DF84.8 An Autism Diagnostic Observation Schedule, 2nd Edition Calibrated Severity Score (ADOS-2 CSS) ≥ 4 The ASD diagnosis must be verified by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Autism Spectrum Disorder Checklist The ASD diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conference Parents must have sufficient Danish (or English) language skills to communicate with the therapist Signed informed consent by parents or holders of legal guardianship Exclusion Criteria: Children having a sibling already included in the trial Hearing and visual impairment in child or parent Parent not available for regular sessions with the therapist, evaluated at the consent meeting

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PACT + Management as usual<br>PACT + management (MAU - see comparator intervention). PACT is a parent-mediated and video-aided intervention designed to improve socio-communicative functioning in children with ASD. The intervention is based on theory and research on pre-linguistic and early social interaction and language development. The programme focuses on changing the interaction in the parent-child dyad in order to enhance communication and language development and skills in children with ASD. The overall focus of the intervention is to guide parents to provide a sensitive, highly adapted interaction context in which their own responses and language are matched to the child's communication competence and language comprehension. Parents learn to identify windows of opportunity to facilitate joint interactions, enhance emerging communication, elicit child intentionality and support language comprehension, thereby aiming to ameliorate abnormal developmental pathways. | Behavioral: PACT<br>* Paediatric Autism Communication Therapy<br>|
| Active Comparator: Management as usual<br>Enhanced management as usual (MAU). MAU is delivered by the regional Child and Adolescent Mental Health Center (CAMHS). All participants will have equal access to seek advice via a telephone hotline in the trial period (12 months). Following the diagnosis of ASD, the parents will be offered psychoeducation as usual in the local CAMHS. A telephone hotline open to all participants will offer pedagogical advice and try to help the parents to collaborate and engage with their professional partners in the municipality. The parents will also be able to contact the CAMHS when needed. The hotline team will be able to consult with the responsible clinician at the CAMHS. The clinician should always be notified within the same day, if a parent describes acute worsening of the child's condition, risk of suicidality, or severe aggression. The responsible clinician will be able to refer the child to further assessment and treatment within the CAMHS without any significant delay. | Behavioral: MAU<br>* Management as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Symptoms | Autism symptoms are measured by Diagnostic Observation schedule, 2nd Edition, Calibrated Severity Score (ADOS-2 CSS). Range 0-10, with 10 indicating the highest symptom severity. | End of intervention (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child adaptive functioning | Child adaptive functioning, or personal and social skills needed for everyday living will be measured by the Vineland Adaptive Behavior Scales, 3rd Edition (VABS-3), an online questionnaire filled in by parents. Each of four domains, Communication, Daily Living Skills, Socialization and Motor Skills are divided into 3 sub-domains. Each item is scored on a Likert-type format with scores 0 (never), 1(sometimes), and 2 (usually or often). Individual items scores are summed to a raw composite score and converted into a standard scale scores. Higher scores indicate higher functioning. | End of intervention (12 months) | 
| Social interaction of the child | Brief Observation of Social Communication Change (BOSCC) is rated on a 12-minute videotaped parent-child play-session. Each of the 15 behavioural items is coded using an empirically based decision tree that captures information regarding the behaviour including frequency and quality. Each item is rated on a 6- point scale from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning). For measuring change only item 1-12 (range 0-60) are used. | At 6 month and end of intervention (12 months) | 
| Quality of Life (child) | Parents' assessment of their child's quality of life with Pediatric Quality of Life Inventory (PEDSQL), a questionnaire including 23 items covering four dimensions of health related quality of life. Each item is rated between 0 and 100. A higher score indicates a higher level of health-related quality of life. The mean item score is used as outcome. | End of intervention (12 months) | 
| Quality of life (parents) | Parent quality of life is measured by the questionnaire World Health Organization Quality of Life assessment- BREF (WHOQOL-BREF), including 28 items of quality of life for parents in 4 dimensions: Physiological, emotional, social and context. The item scores range from 1 to 5 with higher scores denoting higher quality of life. As the number of items differs for each subscale, the mean item score is used as outcome. | End of intervention (12 months) |