Trial Outcomes & Findings for Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism (NCT NCT06477666)

Description of the Impact of the Modelo Sentido's® on Adaptive Behaviors in Children With Autism

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) 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)

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).

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)

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).

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).