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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: PACT; Behavioral: MAU

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niels Bilenberg, Professor; Phone Number: +4599448683; Email: Niels.Bilenberg@rsyd.dk

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Recruiting
    • Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark
    • Contact: Niels Bilenberg, Professor
  • Aalborg, Denmark, 9000
    • Recruiting
    • Child and Adolescent Mental Health Center, Aalborg, North Denmark Region
    • Contact: Marlene Lauritsen, Professor
  • Aarhus, Denmark, 8200
    • Recruiting
    • Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital
    • Contact: Per H Thomsen, Professor
  • Hellerup, Denmark, 2900
    • Recruiting
    • Child and Adolescent Mental Health Center, Capital Region of Denmark
    • Contact: Birgitte Fagerlund, Professor
  • Odense, Denmark, 5000
    • Recruiting
    • Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark
    • Contact: Niels Bilenberg, Professor
  • Roskilde, Denmark, 4000
    • Recruiting
    • Department of Child and Adolescent Psychiatry, Copenhagen University Hospital
    • Contact: Pia Jeppesen, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PACT + Management as usual; 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; Paediatric Autism Communication Therapy
Active Comparator: Management as usual; 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; Management as usual

What is the study measuring?

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 (14 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 (14 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 (14 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 (14 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 (14 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental reflective functioning	Parental reflective functioning will be measured by the Parental Reflective Functioning Questionnaire (PRFQ-1) with 18 items all rated on a 7-point scale with (7 if you strongly agree; and 1 if you strongly disagree. The midpoint, if you are neutral or undecided, is 4). High score indicate highly or hyper- reflective	End of intervention (12 months)
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.	At 6 month and end of intervention (14 months)
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.	End of intervention (14 months)
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	End of intervention (14 months)
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.	End of intervention (14 months)
Social impairment	The presence and severity of social impairment will be measured by the Social Responsiveness Scale, 2nd Edition (SRS-2). A parent reported questionnaire with 65 items identifying the presence and severity of social impairment. Each item is scored on a 4 point Likert-scale: 1 ("not true"); 2 ("sometimes true); 3 (often true); and 4 ("almost always true"). Scores are obtained for five Treatment Subscales: Social Awareness; Social Cognition; Social Communication; Social Motivation; and Restricted Interests and Repetitive Behavior. Higher scores indicating more severe impairment.	End of intervention (14 months)
Child attachment	Parents' perception of their child's attachment is rated on the Maternal Perception of Child Attachment (MPCA). This parent-report measure consists of 23 items rated on a 5-point rating scale, ranging from frequently (1) to never (5). High scores indicate maternal perceptions of strong child attachment.	End of intervention (14 months)
Adverse events	Adverse events that occur during the study will be measured by the Negative Effects Questionnaire (NEQ). The NEQ questionnaire measures six factors; symptoms, quality, dependency, stigma, hopelessness, and failure. The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely" (0-4). Third, the respondents attribute the negative effect to "The treatment I received" yes/no (1/0).	End of intervention (14 months)
Serious Adverse Events	Serious Adverse Events (SAE) defined as any adverse event (AE) that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, or results in persistent or significant disability or incapacity is registered continuously through patient files	End of intervention (14 months)
Cost-effectiveness	The costs of delivering PACT combined with MAU compared to MAU alone will be estimated through cost-effectiveness analyses of intervention deliveries and parents' productivity loss	End of intervention (14 months)
Parents' perceptions of the intervention	Parents' perceptions of the intervention will be explored in a subsample of parents in each intervention group by qualitative interviews	End of intervention (14 months)
Receptive language	Child receptive language as measured by the Mullens Scales of Early Learning (MSEL). The MSEL consists of four cognitive scales: Visual Reception, Fine Motor, Receptive Language, Expressive Language, as well as a Gross Motor Scale, and can be administered to infants and children up to 5 years, 6 months of age. The MSEL receptive language raw scores will be used for the total study population in order to use the same instrument for all children, even when some of them may be older than the validated target group.	End of intervention (14 months)
Language	Child language as measured by the New Reynell Developmental Language Scale (NRDLS). The NRDLS covers a number of important aspects of language acquisition including vocabulary, sentence structure, verb morphology, inference, and grammaticality judgement. NRDLS is developed for children 2-7 years of age. The NRDLS raw scores will be used for the total study population in order to use the same instrument for all children, even when some of them may older than the validated target group at follow-up.	End of intervention (14 months)

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Central Denmark Region; Region Capital Denmark; Region of Southern Denmark; Copenhagen Trial Unit, Center for Clinical Intervention Research; Region Zealand; Regionshospital Nordjylland
• Investigators: Study Chair: Niels Bilenberg, Professor, Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark + Clinical Institute, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: DAN-PACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the results have been published, we aim to make a depersonalized dataset publicly available on e.g. clinicaltrials.gov and/or the European Union (EU) Zenodo database. The final choice will reflect which platform(s) that are compliant with current legislation at that time.
• IPD Sharing Time Frame: When the results have been published
• IPD Sharing Access Criteria: Researchers with a protocol for their planned study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No