Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Parenting Stress Index - 4 Short Form
研究概览
简要总结
Autism spectrum disorders (ASD) are disabling and impairing conditions affecting 1% of children in Norway. ASD is hallmarked by severe social deficit and lack of independence causing reliance on supportive systems throughout life. Parents are usually the primary caretakers and support, often throughout life. Normal parenting skills are however often ineffective due to the social dysfunction of the child with ASD. This causes high stress as the demands exceed the resources and capability of the parent. The high stress is associated to increased risk for mental health problems, divorce, unemployment and reduced quality of life. High parent stress may also reduce the effect of interventions in ASD. However, although the need is great and parental follow-up is an integral part of health care for ASD children, there is a lack of evidence for such interventions.
The current project aims to evaluate a specific parent program that is in clinical use - the Incredible Years for children with ASD - compared with a standardised treatment as usual (TAU) composed of clinical parent workshops ("first aid for parents").
The aim is to evaluate parenting interventions and promote evidence-based practice in a clinical setting. The investigators will perform a randomized controlled trial and qualitative interviews to compare the effectiveness of treatment as usual (TAU) versus a manualized parent program (IY-ASLD). The study aims to investigate if the parental program may reduce parent stress and improve parental competence and self-efficacy. Secondary goals are to investigate whether the parent program may improve quality of life for the parent and the child and have an impact on long-term child functioning and service use.
详细描述
Parental psychoeducation is an integral and intuitive part of health care for children with autism, but there is a lack of evidence for such interventions in general and for parental programs specifically. Studies are usually few and of poor methodological quality. Proper evaluation of parental programs is time and resource consuming. Being able to provide evidence-based parent programs is nevertheless paramount to clinical follow-up, as parents are the most crucial person in a child's life. Efficient parent programs could potentially have enormous downstream beneficial effects, as there is evidence that developmental social pragmatic treatment for parents may improve the child's functioning, but it is currently little known what kind of parent programs should be administered to whom, to what extent or in what form. Many different types of programs exist and there are some indications of what components are necessary for effect. One of the few manualized parent programs for ASD that are available in Norwegian services is the Incredible Years Autism Spectrum and Language Delay Programme (IY-ASLD©). The current project has brought together three Norwegian clinics using the IY-ASLD© to perform a multi-center RCT study. The aim is to evaluate parenting intervention in the early years for families and children with ASD.
The project hypothesizes that empowering parents to be efficient in their role as parents for children with ASD will have both short-term and long-term gains:
Short-term:
- Improved parental stress and health
- Improved parental competence and self-efficacy
- Improved quality of life (QoL) for parents
- Improved quality of life (QoL) for children
Long-term:
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
- None
盲法说明
All measures are parent reported
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
- •Parent of child diagnosed with an autism spectrum disorder, age 2-6
排除标准
- •Level of Norwegian insufficient to benefit from a parental program without the use of an interpreter
- •Ongoing major crisis in the family or major disabling condition in the participating parent
- •Ongoing participation in another manualized (any) parent program
研究组 & 干预措施
Incredible Years Autism Spectrum and Language Delay Programme
Incredible Years Autism Spectrum and Language Delay Programme is a manualised group based intervention in 13 weekly 2-hour sessions. The programme targets parents of children aged 2-6 years, with autism spectrum disorder or language delay.
干预措施: Incredible Years Autism Spectrum and Language Delay Programme (Behavioral)
First Aid for Parents
"First Aid for Parents" is a program consisting of three full day work-shops targeting communication, interaction and daily living skills for parents of children with autism spectrum disorders
干预措施: First Aid for Parents (Behavioral)
结局指标
主要结局
Parenting Stress Index - 4 Short Form
时间窗: Change from Baseline Parent Stress at 30 months
The PSI SF is a 36-item parental self-report questionnaire that assesses the stress related to interaction with the child, in relationship to the parents' personal situation and well-being. It has good psychometric properties and is one of the most commonly used questionnaires globally and is used in the corresponding studies of parental programs. To be filled in individually by all participating adults.
Parenting Stress Index - 4 Short Form
时间窗: Change from Baseline Parent Stress at 6 months
The PSI SF is a 36-item parental self-report questionnaire that assesses the stress related to interaction with the child, in relationship to the parents' personal situation and well-being. It has good psychometric properties and is one of the most commonly used questionnaires globally and is used in the corresponding studies of parental programs. To be filled in individually by all participating adults.
Parenting Stress Index - 4 Short Form
时间窗: Change from Baseline Parent Stress at 18 months
The PSI SF is a 36-item parental self-report questionnaire that assesses the stress related to interaction with the child, in relationship to the parents' personal situation and well-being. It has good psychometric properties and is one of the most commonly used questionnaires globally and is used in the corresponding studies of parental programs. To be filled in individually by all participating adults.
次要结局
- The Pediatric Quality of Life Inventory (PedsQL)(Change from baseline child quality of life at 30 months)
- Parenting Sense of Competence Scale (PSOC)(Change from baseline parent competence at 30 months)
- The Vineland Adaptive Behavior Scales - Second Edition(Change from Baseline daily function of child at 30 months)
- Concomitant Treatment and Resources (Concom)(Use of services at 30 months)
- The Vineland Adaptive Behavior Scales - Second Edition(Change from Baseline daily function of child at 18 months)
- The Pediatric Quality of Life Inventory (PedsQL)(Change from baseline child quality of life at 6 months)
- The Pediatric Quality of Life Inventory (PedsQL)(Change from baseline child quality of life at 18 months)
- Parenting Sense of Competence Scale (PSOC)(Change from baseline parent competence at 6 months)
- Parenting Sense of Competence Scale (PSOC)(Change from baseline parent competence at 18 months)
- Concomitant Treatment and Resources (Concom)(Use of services at 18 months)