Description of the Impact of the Modelo Sentido's® on the Adaptive Behaviors of Children Between 3 and 7 Years Old, on the Autism Spectrum and Other Associated Neurodevelopmental Challenges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To describe the facts observed with respect to the goals agreed upon with the significant caregivers of the children between 3 and 7 years old in the EA and DNDA and their intervening therapists, through the Goal attainment scaling.
研究概览
简要总结
Knowing the impact of the Modelo Sentido´s® (MS) on the gain of adaptive behaviors in children on the autism spectrum (AS) and other associated neurodevelopmental challenges (ANDC), is essential to improve the quality of life of children, families and professionals who live with neurodevelopmental challenges; inform parents about the efficacy and effectiveness of the interventions offered; provide scientific knowledge required by government agencies, public and private policy makers to make informed decisions about which intervention they should support; contribute with a manualized intervention program contextually appropriate to the strengths and challenge within a low- and middle-income country, which can potentially be modified by reverse engineering to apply it to environments that require it in high-income countries.
MS is a proposal for understanding and therapeutic intervention on the dimensional complexity involved in the challenges of neurodevelopment. MS provides a clinical practice framework that generates, drives, and sustains interaction and collaboration between disciplines converging in transdisciplinarity. MS promotes understanding, reasoning, and intervention on the Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of childhoods in AS and other ANDC, their significant caregivers and intervening therapists. MS focuses its bases on three evidence-based frameworks: the applied behavior analysis (ABA), sensory integration (SI) and psychoimmunoneuroendocrinology (PINE) correlate of the neurobiology of stress. Which emerge from behavioral sciences, developmental sciences, neurosciences, and stress sciences. Evidence supports that interventions in children with AS beyond addressing core symptoms should focus on outcome measures, such as quality of life and adaptive functioning. MS focuses its programs on supporting and accompaniment to parents and significant caregivers as a fundamental aspect for gaining adaptive behaviors in childhood. MS provides tools that encourage and develop adaptive behaviors in childhood in EA and other ANDC; In turn, MS enhances the families' competencies, confidence, and caring skills towards their child.
详细描述
Describing the impact of the Modelo Sentido's® on the adaptive behaviors of children from 3 to 7 years old, on the autism spectrum and other associated neurodevelopmental challenges, is extremely important for at least 5 (five) reasons. First, and most importantly, improve the quality of life of children, families and professionals who live with neurodevelopmental challenges. Secondly, parents need to be informed about the efficacy and effectiveness of the interventions offered. Third, this type of scientific knowledge is required by government agencies, public and private policy makers, as well as prepaid and social works so that they can make informed decisions about what type of intervention they should support. Fourth, contribute to the availability of a manualized intervention program contextually appropriate to the strengths and challenges within a low- and middle-income country, which could potentially be modified by reverse engineering to apply to environments that require it in high-income countries. Fifth, provide evidence-based data and know if the programs created through MS adjust to the population needs and cultural particularities of our region.
This study will be carried out in three time phases, through scales administered by health professionals to the significant caregivers (parents, grandparents or legal guardians) of the participants: the 1st phase will be before starting the intervention at the time of therapeutic admission, the 2nd phase will be after 14 weeks of intervention, and, the 3rd phase will be after two weeks without intervention at week 17 of the study.
Modelo Sentido´s is a proposal for understanding and therapeutic intervention on the dimensional complexity involved in neurodevelopmental challenges, which are a group of heterogeneous conditions that are characterized by an alteration in the acquisition of skills in a variety of developmental domains. including motor, social, language and cognition, are associated with difficulties in cognitive, behavioral, social, academic, and adaptive functioning; Within these, the autism spectrum is characterized by widespread deficits in social communication skills, restricted and repetitive interests and behaviors, and sensory difficulties that affect individual and family functioning. This new conception of the Autism Spectrum (AS) and other Associated Neurodevelopmental Challenges (ANDCH) has led to the search for more global, early, and intensive practices that adopt transdiagnostic intervention approaches. The availability of manualized and contextually appropriate intervention programs presents an additional challenge within low- and middle-income countries. Despite these limitations, different studies are conclusive based on information that allows us to trace a path from the theory of change towards innovations. Worldwide. spectrum of autism care in low- and middle-income countries, which could potentially be reverse engineered to apply to settings requiring it in high-income countries.
Sense Model (MS) highlights in its processes the perspective of transcomplexity, which is immersed in various metadomains of knowledge were psychology, anthropology, spirituality, linguistics, ecology, economics, history, philosophy, among other.
MS provides a clinical practice framework that generates, drives, and sustains interaction and collaboration between disciplines that converge in transdisciplinarity; promotes understanding, reasoning, and intervention on the Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of childhoods in AS and other ANDCH, of their significant caregivers and intervening therapists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the parent or guardian.
- •Complete the executive admission requirements (see ANNEX).
- •Meet the diagnostic impression criteria for DSM-V neurodevelopmental disorders:
- •Intellectual disability (ID); global developmental delay (RDSM) or psychomotor delay (PMR);
- •Communication disorders: language disorders (TL), speech disorders, social communication disorder (SUD), childhood-onset disfluency;
- •Autism spectrum disorder (ASD)
- •Attention-deficit/hyperactivity disorder (ADHD) - Motor development disorders: developmental coordination disorder (DCD), stereotypic movement disorder, tic disorders, Tourette's disorder (TT), chronic tic disorder (CTT), transient tic disorder;
- •Specific learning disorders ( TAp ).
- •Answer the GAS, Vineland-3 and FOS scales, at therapeutic admission.
- •Willingness of significant caregivers to accompany the intervention process, for twelve sessions according to syllabus protocol.
排除标准
- •Childhoods that exceed the age of 7 years in the study period.
- •Children diagnosed with neurological or genetic diseases, brain injury, visual, auditory or motor sensory deficits.
- •Children who are under the guardianship of the Argentine State.
研究组 & 干预措施
Sentido's® Model Intervention Group
Single intervention group receiving the Sentido's® Model for 14 weeks. Participants are children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental challenges. All participants receive individualized intervention protocols combining ABA, ASI, and PINE approaches with family participation. Sessions are conducted at a specialized neurodevelopment center in Comodoro Rivadavia, Argentina. Following the 14-week active intervention period, participants undergo a 3-week follow-up assessment period without direct intervention to evaluate maintenance of treatment effects.
干预措施: Sentido's® Model (Behavioral)
结局指标
主要结局
To describe the facts observed with respect to the goals agreed upon with the significant caregivers of the children between 3 and 7 years old in the EA and DNDA and their intervening therapists, through the Goal attainment scaling.
时间窗: 17 week, from october 2023 to October 2024
It is a consistent outcome measure for evaluating aspects of therapeutic progress that are difficult to assess using standardized measures. The GAS standard measurement system is based on a 5-point response scale: -2 (worst expected outcome), -1 (lower than expected outcome), 0 (expected outcome), +1 (higher than expected outcome) and +2 (much higher than expected outcome).
To describe the impact of Modelo Sentido's® on the adaptive behaviors of the infancy between 3 and 7 years old, on the autism spectrum and other associated neurodevelopmental challenges.
时间窗: 17 week, from october 2023 to October 2024
To describe the impact of the Modelo Sentido's® on the adaptive behaviors of the infancy aged 3 to 7 years, on the autism spectrum and other associated neurodevelopmental challenges, attending Sentido's Therapeutic Organization, Pediatric Comprehensive Care Center and Intensive Behavioral Intervention Center (Comodoro Rivadavia, Chubut, Argentina) during a 17-week period, from October 2023 to October 2024.
To detect and describe through the administration of Vineland-3 (Vineland Adaptive Behavior Scales - Third Edition) the domains and subdomains of adaptive behaviors/skills acquired after 17 weeks in children aged 3 to 7 years in EA and DNDA.
时间窗: 17 week, from october 2023 to October 2024
The Vineland-3 Comprehensive Interview, Parent Form contains 502 items designed to measure five domains, including Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. In this study, we will focus on the 12 subdomains that contribute to the Communication, Daily Living Skills, and Socialization domains. In each subdomain, key behaviors are organized developmentally such that behaviors expected of very young children precede those expected of older children and so on.
Vineland-3 Adaptive Behavior Composite Score
时间窗: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Parent/Caregiver Comprehensive Interview Form assesses adaptive functioning across Communication, Daily Living Skills, Socialization, and Motor domains. The Adaptive Behavior Composite (ABC) is a summary standard score representing overall adaptive functioning. Standard scores have a mean of 100 and SD of 15, with higher scores indicating better adaptive functioning. The ABC was measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA comparing scores across the three time points. The values reported in the Outcome Measure data table represent standardized scores (standard scores), not raw scores. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition. Minimum value: 20 Maximum value: 160 Higher scores mean: Better outcome (better adaptive functioning)
Goal Attainment Scaling (GAS) Scores
时间窗: Baseline (Week 0), Post-intervention (Week 14), Follow-up (Week 17)
Goal Attainment Scaling (GAS) is a personalized outcome measure quantifying progress toward individually defined therapeutic goals. Each of the 24 participants had 3 goals established collaboratively with therapists at baseline. Progress was rated on a modified 5-point ordinal scale: -2 (baseline level/no progress), -1 (less than expected), 0 (expected), +1 (somewhat more than expected), +2 (much more than expected). Higher scores indicate greater goal attainment. The Outcome Measure data table reports the number of participants who achieved expected progress or better (scores ≥0) for each objective at each time point. Data are reported as frequency distributions across score categories. Goals were assessed at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Full scale name: Goal Attainment Scaling Raw scale: 5-point ordinal from -2 to +2 Higher scores mean: Better outcome (greater goal attainment)
Family Outcome Survey (FOS) Total Score
时间窗: Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up)
The Family Outcome Survey (FOS) is a validated self-report questionnaire that assesses family quality of life and the impact of therapeutic services on family functioning. The FOS generates a total score ranging from 0 to 100, with higher scores indicating better family outcomes and satisfaction with services. The survey was administered to caregivers at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Full scale name: Family Outcome Survey Score range: 0-100 Higher scores mean: Better outcome (improved family functioning and satisfaction with therapeutic services).
次要结局
- Vineland-3 Communication Domain Score(Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up))
- Vineland-3 Daily Living Skills Domain Score(Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up))
- Vineland-3 Socialization Domain Score(Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up))