NCT05673096

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

December 22, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 22, 2022

Last Update Submit

December 5, 2024

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (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.

    End of intervention (14 months)

Secondary Outcomes (4)

  • Child adaptive functioning

    End of intervention (14 months)

  • Social interaction of the child

    At 6 month and end of intervention (14 months)

  • Quality of Life (child)

    End of intervention (14 months)

  • Quality of life (parents)

    End of intervention (14 months)

Other Outcomes (13)

  • Parent-child synchrony and initiative in communication

    At 6 month and end of intervention (14 months)

  • Parent implementation of strategy

    End of intervention (14 months)

  • Behavioural and emotional problems

    End of intervention (14 months)

  • +10 more other outcomes

Study Arms (2)

PACT + Management as usual

EXPERIMENTAL

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

Management as usual

ACTIVE COMPARATOR

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

Interventions

PACTBEHAVIORAL

Paediatric Autism Communication Therapy

PACT + Management as usual
MAUBEHAVIORAL

Management as usual

Management as usual

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Aabenraa, 6200, Denmark

RECRUITING

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

Aalborg, 9000, Denmark

RECRUITING

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

Aarhus, 8200, Denmark

RECRUITING

Child and Adolescent Mental Health Center, Capital Region of Denmark

Hellerup, 2900, Denmark

RECRUITING

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

Odense, 5000, Denmark

RECRUITING

Department of Child and Adolescent Psychiatry, Copenhagen University Hospital

Roskilde, 4000, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40883837DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • 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 CHAIR

Central Study Contacts

Niels Bilenberg, Professor

CONTACT

+4599448683Niels.Bilenberg@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, blinding of parents and therapists is impossible. The primary outcome measure, Autism Diagnostic Observation Schedule, Calibrated Severity Score (ADOS-CSS), and further outcomes (Brief Observation of Social Communication Change (BOSCC), Dyadic Communication Measure for Autism (DCMA) and Measure of Naturalistic Developmental Behavioral Intervention Strategy Implementation - Caregiver Change (MONSI-CC)) are videotaped, leaving raters blinded to treatment allocation. At the clinical follow-up assessment, families are asked not to reveal group allocation. 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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 6, 2023

Study Start

March 13, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
When the results have been published
Access Criteria
Researchers with a protocol for their planned study

Locations

DK(6)