Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
MS focuses its foundations on three evidence-based frameworks; applied behavioral analysis (ABA), sensory integration (SI) and psychoimmunoneuroendocrinology (PINE) as main stress medicine (correlated with stress neurobiology). Which arise from behavioral sciences, developmental sciences, neurosciences, and stress sciences. MS focuses his work on the acquisition of adaptive behaviors/skills, driven by various research that confirms that children with AD show adaptive skills in different lower domains compared to those of children with typical development. Evidence suggests that interventions in children with AD, beyond addressing core symptoms, should focus on outcome measures, such as quality of life and adaptive functioning. Studies of young children suggest that more responsive caregivers are more likely to develop relationships.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentido's® Model Intervention Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentido's® Model | Behavioral | The Sentido's® Model is an integrated intervention approach that combines Applied Behavior Analysis (ABA), Ayres Sensory Integration (ASI), and Psychoimmunoendocrinology (PINE) within a transcomplexity theoretical framework. The intervention addresses Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of development through individualized treatment protocols. Sessions are delivered by trained therapists with active family participation in a specialized neurodevelopment center setting. The intervention duration is 14 weeks with protocol-specific scheduling based on individual participant needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Vineland-3 Adaptive Behavior Composite Score | 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) | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
| Goal Attainment Scaling (GAS) Scores | 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) | Baseline (Week 0), Post-intervention (Week 14), Follow-up (Week 17) |
| Family Outcome Survey (FOS) Total Score | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Vineland-3 Communication Domain Score | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Communication domain assesses receptive, expressive, and written communication skills. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better communication functioning. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Communication Domain Score range: 20-160 Higher scores mean: Better outcome (better communication skills) |
Not provided
Inclusion Criteria:
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:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bárbara M Tomás, PhD(c) | Instituto Universitario en Ciencias de la Salud - Fundación H. A. Barceló | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Organización Terapéutica Sentido´s CAIP&CICI (Centro de Atención Integral Pediátrico y Centro de Intervención Conductual Intensiva) | Comodoro Rivadavia | Chubut Province | 9000 | Argentina |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sentido's® Model Intervention Group | Single-arm intervention group receiving the Sentido's® Model, an integrated intervention approach combining Applied Behavior Analysis (ABA), Ayres Sensory Integration (ASI), and Psychoimmunoendocrinology (PINE) within a transcomplexity theoretical framework. The intervention addresses Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of development in children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental challenges. The intervention was delivered for 14 weeks followed by a 3-week follow-up period without direct intervention to assess maintenance of gains. All participants (n=24) received the same intervention protocol delivered through individual sessions with family participation in a specialized neurodevelopment center in Comodoro Rivadavia, Chubut, Argentina. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Sentido's® Model: The Sentido's® Model is an integrated intervention approach that combines Applied Behavior Analysis (ABA), Ayres Sensory Integration (ASI), and Psychoimmunoendocrinology (PINE) within a transcomplexity theoretical framework. The intervention addresses Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of development through individualized treatment protocols. Sessions are delivered by trained therapists with active family participation in a specialized neurodevelopment center setting. The intervention duration is 14 weeks with protocol-specific scheduling based on individual participant needs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vineland-3 Adaptive Behavior Composite Score | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
|
17 weeks total: 14 weeks active intervention (4 sessions per week) plus 3 weeks follow-up. All adverse events (serious and non-serious) were systematically monitored throughout the study period. Trained therapists assessed participants at each session and documented any adverse events or safety concerns. Parents/caregivers received instructions to report any health issues immediately. No adverse events were observed or reported during the study period.
All adverse events were systematically monitored throughout the 14-week intervention period. All 24 participants were assessed at each therapy session (4 times weekly) by trained therapists who documented any adverse events or safety concerns. Parents/caregivers were instructed to report any health issues immediately. No adverse events (serious or non-serious) were observed or reported during the study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sentido's® Model Intervention Group | Single-arm intervention group receiving the Sentido's® Model, an integrated intervention approach combining Applied Behavior Analysis (ABA), Ayres Sensory Integration (ASI), and Psychoimmunoendocrinology (PINE) within a transcomplexity theoretical framework. The intervention addresses Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of development in children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental challenges. The intervention was delivered for 14 weeks followed by a 3-week follow-up period without direct intervention to assess maintenance of gains. All participants (n=24) received the same intervention protocol delivered through individual sessions with family participation in a specialized neurodevelopment center in Comodoro Rivadavia, Chubut, Argentina. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bárbara Muriel Tomás | Sentido´s CAIP & CICI | +54 2974635050 | tomasbarbara@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Sep 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2023 | Sep 22, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
Not provided
Not provided
Single-arm pre-post intervention study with follow-up. All participants receive the same Sentido's® Model intervention for 14 weeks, followed by a 3-week follow-up period without direct intervention to assess maintenance of treatment gains. No control group or randomization employed in this preliminary effectiveness study.
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
| Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
| Vineland-3 Daily Living Skills Domain Score | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Daily Living Skills domain assesses personal, domestic, and community living activities. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better daily living skills. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Daily Living Skills Domain Score range: 20-160 Higher scores mean: Better outcome (better daily living skills). | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
| Vineland-3 Socialization Domain Score | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Socialization domain assesses interpersonal relationships, play and leisure time, and coping skills. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better socialization. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Socialization Domain Score range: 20-160 Higher scores mean: Better outcome (better socialization skills). | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants with Autism Spectrum Disorder Diagnosis | Count of Participants | Participants |
|
| Sentido's® Model Intervention Group |
Single-arm intervention group receiving the Sentido's® Model, an integrated intervention approach combining Applied Behavior Analysis (ABA), Ayres Sensory Integration (ASI), and Psychoimmunoendocrinology (PINE) within a transcomplexity theoretical framework. The intervention addresses Bio-Neuro-Sensory-Psycho-Social-Spiritual-Occupational-Nutritional-Ecological dimensions of development in children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental challenges. The intervention was delivered for 14 weeks followed by a 3-week follow-up period without direct intervention to assess maintenance of gains. All participants (n=24) received the same intervention protocol delivered through individual sessions with family participation in a specialized neurodevelopment center in Comodoro Rivadavia, Chubut, Argentina. |
|
|
|
| Primary | Goal Attainment Scaling (GAS) Scores | 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) | Children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental disorders who complete the Sentido® Model intervention and have GAS evaluations at all three time points. | Posted | Number | Participants | Baseline (Week 0), Post-intervention (Week 14), Follow-up (Week 17) |
|
|
|
|
| Secondary | Vineland-3 Communication Domain Score | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Communication domain assesses receptive, expressive, and written communication skills. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better communication functioning. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Communication Domain Score range: 20-160 Higher scores mean: Better outcome (better communication skills) | Children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental disorders who completed the Sentido Model intervention and have Communication domain assessments at all three time points. All 24 enrolled participants completed with no missing data. | Posted | Mean | Standard Error | Standard score | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
|
|
|
|
| Secondary | Vineland-3 Daily Living Skills Domain Score | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Daily Living Skills domain assesses personal, domestic, and community living activities. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better daily living skills. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Daily Living Skills Domain Score range: 20-160 Higher scores mean: Better outcome (better daily living skills). | Children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental disorders who completed the Sentido Model intervention and have Daily Living Skills domain assessments at all three time points. All 24 enrolled participants completed with no missing data. | Posted | Mean | Standard Error | standard score | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
|
|
|
|
| Secondary | Vineland-3 Socialization Domain Score | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Socialization domain assesses interpersonal relationships, play and leisure time, and coping skills. The domain yields a standard score (mean=100, SD=15), with higher scores indicating better socialization. Scores were measured at baseline, 14 weeks (post-intervention), and 17 weeks (follow-up). Change was assessed using repeated measures ANOVA. Unabbreviated scale title: Vineland Adaptive Behavior Scales, Third Edition - Socialization Domain Score range: 20-160 Higher scores mean: Better outcome (better socialization skills). | Children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental disorders who completed the Sentido Model intervention and have Socialization domain assessments at all three time points. All 24 enrolled participants completed with no missing data. | Posted | Mean | Standard Error | Standard score | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
|
|
|
|
| Primary | Family Outcome Survey (FOS) Total Score | 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). | Children aged 3-7 years with autism spectrum disorder and associated neurodevelopmental disorders who completed the Sentido´s Model intervention. Caregivers of all 24 enrolled participants completed the Family Outcome Survey at all three time points with no missing data. | Posted | Mean | Standard Error | points on scale | Baseline, 14 weeks (post-intervention), and 17 weeks (follow-up) |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Analysis of GAS scores for Objective 1 (n=24) across three time points (baseline, 14 weeks, 17 weeks). | Chi-squared | Friedman test applied to GAS scores (-2 to +2) at baseline, 14 and 17 weeks. Chi-square = 43.053. | < 0.001 | Proportion achieving expected or better | 0.833 | 2-Sided | 95 | 0.625 | 0.938 | Other | Friedman test applied (non-parametric alternative to repeated measures ANOVA for ordinal data). |
| Analysis of GAS scores for Objective 2 (n=24) across three time points (baseline, 14 weeks, 17 weeks). | Chi-squared | Friedman test applied to GAS scores (-2 to +2) at baseline, 14 and 17 weeks. Chi-square = 40.083. | < 0.001 | Proportion achieving expected or better | 0.750 | 2-Sided | 95 | 0.530 | 0.893 | Other | Friedman test applied (non-parametric alternative to repeated measures ANOVA for ordinal data). |
| Analysis of GAS scores for Objective 3 (n=23) across three time points (baseline, 14 weeks, 17 weeks). One missing data point. | Chi-squared | Friedman test applied to GAS scores (-2 to +2) at baseline, 14 and 17 weeks. Chi-square = 29.789. | < 0.001 | Proportion achieving expected or better | 0.652 | 2-Sided | 95 | 0.432 | 0.822 | Other | Friedman test applied (non-parametric alternative to repeated measures ANOVA for ordinal data). |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|