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AzTrials

Autism Spectrum DisorderDAN-PACTNCT05673096

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

A study testing PACT and MAU in people with Autism Spectrum Disorder, run by University of Southern Denmark at 6 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
PACT and MAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
6 sitesDenmark
Study dates
13 Mar 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Niels Bilenberg, Professor contact

+4599448683

Niels.Bilenberg@rsyd.dk

6 sites in 1 country

Denmark6 sites, 6 recruiting

  • Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark

    Aabenraa, 6200

    Niels Bilenberg, Professor

    Recruiting

  • Child and Adolescent Mental Health Center, Aalborg, North Denmark Region

    Aalborg, 9000

    Marlene Lauritsen, Professor

    Recruiting

  • Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital

    Aarhus, 8200

    Per H Thomsen, Professor

    Recruiting

  • Child and Adolescent Mental Health Center, Capital Region of Denmark

    Hellerup, 2900

    Birgitte Fagerlund, Professor

    Recruiting

  • Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark

    Odense, 5000

    Niels Bilenberg, Professor

    Recruiting

  • Department of Child and Adolescent Psychiatry, Copenhagen University Hospital

    Roskilde, 4000

    Pia Jeppesen, Professor

    Recruiting

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
PACT, MAU
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PACTBehavioural

    Paediatric Autism Communication Therapy

  • MAUBehavioural

    Management as usual

Study groups in NCT05673096
Study groupRoleWhat they receive
PACT + Management as usualExperimentalPACT + 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.
Receives: Behavioral: PACT
Management as usualActive comparatorEnhanced 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.
Receives: Behavioral: MAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: End of intervention (14 months)

Secondary outcomes (4)

  1. 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.

    Measured: End of intervention (14 months)

  2. 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.

    Measured: At 6 month and end of intervention (14 months)

  3. 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.

    Measured: End of intervention (14 months)

  4. 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.

    Measured: End of intervention (14 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start13 Mar 2023
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673096
Sponsor's protocol ID
DAN-PACT
Acronym
DAN-PACT
Status last verified
Dec 2024
First submitted
22 Dec 2022
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40883837

Questions about this trial

What is this clinical trial studying?

A study testing PACT and MAU in people with Autism Spectrum Disorder, run by University of Southern Denmark at 6 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Niels Bilenberg, Professor (+4599448683, Niels.Bilenberg@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autism Symptoms (time frame: End of intervention (14 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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