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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- Autism Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PACT (Behavioral)
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.
干预措施: MAU (Behavioral)
结局指标
主要结局
Autism Symptoms
时间窗: End of intervention (14 months)
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.
次要结局
- Quality of Life (child)(End of intervention (14 months))
- Quality of life (parents)(End of intervention (14 months))
- Child adaptive functioning(End of intervention (14 months))
- Social interaction of the child(At 6 month and end of intervention (14 months))