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

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

PACT

MAU

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Child and Adolescent Mental Health Center, Aabenraa, Region of Southern DenmarkRecruiting
Child and Adolescent Mental Health Center, Aalborg, North Denmark RegionRecruiting
Child and Adolescent Psychiatric Dept., Skejby, Aarhus University HospitalRecruiting
Child and Adolescent Mental Health Center, Capital Region of DenmarkRecruiting
Child and Adolescent Mental Health Center, Odense, Region of Southern DenmarkRecruiting
Department of Child and Adolescent Psychiatry, Copenhagen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PACT + Management as usual

Management as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT05673096

First Posted

December 22, 2022

Last Updated

May 9, 2023

Sponsor

University of Southern Denmark

Collaborators

Copenhagen Trial Unit, Center for Clinical Intervention Research, Danish Autism Centre, Region Capital Denmark, Region Zealand, Region of Southern Denmark, Central Denmark Region, North Denmark Regional Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05673096

Brief Title

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

Acronym

DAN-PACT

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 13, 2023 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern Denmark

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PACT + Management as usual

Arm Type

Experimental

Arm Description

Arm Title

Management as usual

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

PACT

Intervention Description

Paediatric Autism Communication Therapy

Intervention Type

Behavioral

Intervention Name(s)

MAU

Intervention Description

Management as usual

Primary Outcome Measure Information:

Title

Autism Symptoms

Description

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.

Time Frame

End of intervention (12 months)

Secondary Outcome Measure Information:

Title

Child adaptive functioning

Description

Time Frame

End of intervention (12 months)

Title

Social interaction of the child

Description

Time Frame

At 6 month and end of intervention (12 months)

Title

Quality of Life (child)

Description

Time Frame

End of intervention (12 months)

Title

Quality of life (parents)

Description

Time Frame

End of intervention (12 months)

Other Pre-specified Outcome Measures:

Title

Parent-child synchrony and initiative in communication

Description

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.

Time Frame

At 6 month and end of intervention (12 months)

Title

Parent implementation of strategy

Description

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.

Time Frame

End of intervention (12 months)

Title

Behavioural and emotional problems

Description

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

Time Frame

End of intervention (12 months)

Title

Family life functioning

Description

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.

Time Frame

End of intervention (12 months)

Title

Social impairment

Description

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.

Time Frame

End of intervention (12 months)

Title

Parental reflective functioning

Description

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

Time Frame

End of intervention (12 months)

Title

Child attachment

Description

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.

Time Frame

End of intervention (12 months)

Title

Adverse events

Description

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).

Time Frame

End of intervention (12 months)

Title

Serious Adverse Events

Description

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

Time Frame

End of intervention (12 months)

Title

Cost-effectiveness

Description

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

Time Frame

End of intervention (12 months)

Title

Parents' perceptions of the intervention

Description

Parents' perceptions of the intervention will be explored in a subsample of parents in each intervention group by qualitative interviews

Time Frame

End of intervention (12 months)

Title

Receptive language

Description

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.

Time Frame

End of intervention (12 months)

Title

Language

Description

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.

Time Frame

End of intervention (12 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Niels Bilenberg, Professor

Phone

+4599448683

Niels.Bilenberg@rsyd.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Niels Bilenberg, Professor

Organizational Affiliation

Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark + Clinical Institute, University of Southern Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Aabenraa

ZIP/Postal Code

6200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Bilenberg, Professor

Facility Name

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

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marlene Lauritsen, Professor

Facility Name

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

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Per H Thomsen, Professor

Facility Name

Child and Adolescent Mental Health Center, Capital Region of Denmark

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Birgitte Fagerlund, Professor

Facility Name

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

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Bilenberg, Professor

Facility Name

Department of Child and Adolescent Psychiatry, Copenhagen University Hospital

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pia Jeppesen, Professor

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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