Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder
NCT ID: NCT05673096
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2023-03-13
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Data from the DAN-PACT trial will be kept separate from research data and will not be accessible to the research team. We will follow the rule that statistical analyses are conducted with the intervention groups coded. The steering committee will write two abstracts while the blinding is intact assuming either group as intervention group and control, respectively. After this, the code will be broken
Study Groups
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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.
PACT
Paediatric Autism Communication Therapy
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.
MAU
Management as usual
Interventions
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PACT
Paediatric Autism Communication Therapy
MAU
Management as usual
Eligibility Criteria
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Inclusion Criteria
* 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
* Hearing and visual impairment in child or parent
* Parent not available for regular sessions with the therapist, evaluated at the consent meeting
2 Years
6 Years
ALL
No
Sponsors
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Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Region Capital Denmark
OTHER
Region Zealand
OTHER
Region of Southern Denmark
OTHER
Central Denmark Region
OTHER
Regionshospital Nordjylland
OTHER_GOV
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Niels Bilenberg, Professor
Role: STUDY_CHAIR
Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark + Clinical Institute, University of Southern Denmark
Locations
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Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark
Aabenraa, , Denmark
Child and Adolescent Mental Health Center, Aalborg, North Denmark Region
Aalborg, , Denmark
Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital
Aarhus, , Denmark
Child and Adolescent Mental Health Center, Capital Region of Denmark
Hellerup, , Denmark
Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark
Odense, , Denmark
Department of Child and Adolescent Psychiatry, Copenhagen University Hospital
Roskilde, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Niels Bilenberg, Professor
Role: primary
Marlene Lauritsen, Professor
Role: primary
Per H Thomsen, Professor
Role: primary
Birgitte Fagerlund, Professor
Role: primary
Niels Bilenberg, Professor
Role: primary
Pia Jeppesen, Professor
Role: primary
References
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Ziegler SMT, Jeppesen P, Christiansen J, Conrad CE, Davidsen KA, Engkjaer-Trautwein G, Engstrom J, Fagerlund B, Gotzsche MV, Hastrup LH, Jakobsen JC, Kirk AM, Lauritsen MB, Pagsberg AK, Pedersen MA, Kilburn TR, Thomsen PH, Varenne M, Bilenberg N. Paediatric Autism Communication Therapy (PACT) versus management as usual in autistic children: a protocol for a Danish pragmatic, national, randomised clinical trial: DAN-PACT. Trials. 2025 Aug 29;26(1):322. doi: 10.1186/s13063-025-09017-z.
Other Identifiers
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DAN-PACT
Identifier Type: -
Identifier Source: org_study_id