About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
PACT
BehavioralPaediatric Autism Communication Therapy
MAU
BehavioralManagement as usual
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
Parent-child synchrony and initiative in communication
Dyadic Communication Measure for Autism (DCMA) is used to rate parent synchrony and responsiveness to the child, child communicative initiations, responses and communicative functions, and amount of mutual shared attention between parent and child will be measured by the DCMA. DCMA is rated on a 12-minute videotaped parent-child play-session. Raters will be blinded to treatment allocation.
Parent implementation of strategy
Caregivers' implementation of PACT strategies will be measured by the Measure of Naturalistic Developmental Behavioral Intervention Strategy Implementation - Caregiver Change (MONSI-CC) rated on a 12-minute videotaped parent-child play-session. Each of 21 items are rated between 1 (strategy was rarely implemented) and 5 (strategies were well-timed) and summed on different subscales. Raters will be blinded to treatment allocation.
Behavioural and emotional problems
Child symptoms and problems are measured by the Child Behavior Checklist for ages 1½-5 (CBCL/1½-5). A 99 item questionnaire generating a Total problem Score (range 0-198). Higher score indicating more problems
Family life functioning
Participant family life functioning will be measured by the Autism Family Experience Questionnaire (AFEQ). A parent-reported questionnaire with 48 items (range 48-240). High score indication low function.
Sponsors and contacts
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University of Southern Denmark
Lead sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Region Capital Denmark
Collaborator
Region Zealand
Collaborator
Region of Southern Denmark
Collaborator
Central Denmark Region
Collaborator
Regionshospital Nordjylland
Collaborator