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| Name | Class |
|---|---|
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Region Capital Denmark | OTHER |
| Region Zealand | OTHER |
| Region of Southern Denmark |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACT | Behavioral | Paediatric Autism Communication Therapy |
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| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels Bilenberg, Professor | Contact | +4599448683 | Niels.Bilenberg@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark | Recruiting | Aabenraa | 6200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40883837 | Derived | 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. |
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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.
When the results have been published
Researchers with a protocol for their planned study
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| Central Denmark Region | OTHER |
| Regionshospital Nordjylland | OTHER_GOV |
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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
| MAU |
| Behavioral |
Management as usual |
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| 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) |
| 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) |
| 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) |
| 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) |
| Child and Adolescent Mental Health Center, Aalborg, North Denmark Region | Recruiting | Aalborg | 9000 | Denmark |
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| Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| Child and Adolescent Mental Health Center, Capital Region of Denmark | Recruiting | Hellerup | 2900 | Denmark |
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| Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark | Recruiting | Odense | 5000 | Denmark |
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| Department of Child and Adolescent Psychiatry, Copenhagen University Hospital | Recruiting | Roskilde | 4000 | Denmark |
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