Protocol for a Randomized Pilot Study (FIRST STEPS): Implementation of the Incredible Years-ASLD® Program in Spanish Preschoolers With Autism and Premature Children With Communication or Socialization Difficulties
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Autism Program Parent Final Satisfaction Questionnaire
研究概览
简要总结
Children with autism spectrum disorders (ASD) usually present coexisting problems in emotion and behavior regulation, similarly as premature children with communication or socialization difficulties. Caring for children with neurodevelopmental difficulties is an important stressor for parents. Therefore, it is essential that families are offered evidence-based interventions at an early stage within the public health service. Group therapy is a cost-effective intervention that can help parents of children diagnosed with autism and those born prematurely. The Incredible Years - ASLD program is an example of this sort of therapy, consisting of a group intervention for parents of preschool children with a diagnosis of ASD or Language Delay. In Spain, group interventions for children with ASD and preterm children presenting with Language Delay are scarce in the public health service. The Incredible Years - ASLD program has not been translated into Spanish and it has not been previously implemented in our country.
The Incredible Years - ASLD group intervention will be carried out in three public Healthcare centers. It is intended to recruit 72 patients diagnosed with ASD or premature children with communication or socialization difficulties, which will be randomized to an Intervention Group or to Treatment as Usual (TAU) Group. The Intervention Group will receive fourteen sessions of the Incredible Years - ASLD program in addition to Treatment as Usual (TAU). In terms of clinical implications, this randomized pilot study could demonstrate the feasibility of implementing this intervention in the regular clinical settings within the Spanish public health service and could be a first step for future controlled studies that demonstrate its effectiveness.
详细描述
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3. Premature infants are at particular risk for neurodevelopmental disturbances, such as language delay, difficulties in social communication and ASD.
ASD is often associated with behavior difficulties, emotion regulation difficulties, psychiatric comorbidities and a dysfunctional response to sensory stimuli. Children with premature birth also present difficulties related to emotion and behavior regulation.
Due to these difficulties, caring for children with neurodevelopmental disorders can be very stressful for parents, which could in turn lead to lower effectiveness of interventions and greater mental health difficulties in parents.
Therefore, parenting interventions should not only address children's difficulties, these interventions should also aim to provide support for parents. Since no interventions have specifically addressed these two aspects in the treatment of neurodevelopmental disorders, several therapies have been adapted for this population. This is the case of the intervention at hand: Incredible Years - ASD and Language Delay (IY-ASLD).
In this intervention, in addition to learning strategies to promote the development of skills in children, parents receive support from other parents and from the therapists. The effectiveness of the Incredible Years program has been widely demonstrated in multiple randomized clinical trials, showing an improvement in terms of parental stress levels, depression and parental coping, as well as in children behavior difficulties. Incredible Years is also considered an evidence-based intervention according to the NICE guidelines.
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
入排标准
- 年龄范围
- 24 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria in HGUGM Madrid and HMI Málaga sites:
- •Parents who have signed the Informed Consent.
- •Parents of children diagnosed with ASD.
- •Parents of children between the ages of 2 and 5 years, 11months.
- •Fluency in Spanish.
- •Inclusion criteria in the HSJD Barcelona site:
- •Parents who have signed the informed consent.
- •Parents of children born with gestational age less than 37 weeks.
- •Parents of children with communication or socialization difficulties (Vineland-III scores 1SD below the mean in any of the communication or socialization subdomains).
- •Parents of children between the ages of 2 and 5 years, 11months.
- •Fluency in Spanish
排除标准
- •Attending another structured/manualized parenting program (focused on improving strategies for parents to help their children with behavioral and emotion regulation) at the time of the study.
- •Parents of looked after children.
结局指标
主要结局
Autism Program Parent Final Satisfaction Questionnaire
时间窗: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline).
Questionnaire for parents assessing their satisfaction with the IY-ASLD Program received.
Register sheet of attendance
时间窗: Administered to the intervention group weekly throughout treatment (22 weeks total)
Register of weekly attendance, aimed to determine levels of compliance with the intervention.
Autism Program Parent Weekly Evaluation.
时间窗: Administered to the intervention group weekly throughout treatment (22 weeks total)
Questionnaire assessing levels of satisfaction with each therapy session.This survey was specifically developed for the Incredible Years Program and can be found in the Incredible Years manual
Incredible Years® Parent Strategies Questionnaire for Children with Autism (2-5 years)
时间窗: Administered to the intervention group. Baseline (prior to programme initiation) and immediately after the intervention.
Questionnaire assessing type of parental strategies specifically aimed at helping children with ASD.
次要结局
- Beck Depression Inventory (BDI)(Administered to both arms. First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.)
- Alabama Parenting Questionnaire Preschool revision (APQ-Pr).(Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.)
- Parental Stress Index (PSI-SF) by Abidin.(Administered to both arms.First assessment before the groups randomization, pre-intervention assessment just before the programme initiation (due to the delay of the intervention because the COVID-19 pandemic), and immediately after the intervention.)
- Autism Specify Five Minutes Speech Sample - ASFMSS(Administered to both arms. Baseline (prior to programme initiation) and immediately after the intervention.)