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
Phase: NA
Conditions: Neurodevelopmental Disorders, Autism Spectrum Disorder, Adaptive Behaviors
Sponsor: Sentido's CAIP & CICI Organización Terapéutica

STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN 
 
 
 
 
Oﬃcial (tle: Descrip)on of the impact of the Sen)do's® Model on the adap)ve behaviors 
of children between 3 and 7 years of age, on the au)sm spectrum and other associated 
neurodevelopmental challenges. 
 
Clinical Trials Registry: NCT06477666 
 
Document date: October 30, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SECTION I: STUDY PROTOCOL 

1. SUMMARY OF THE STUDY 
1.1 Background and Jus(ﬁca(on 
Neurodevelopmental challenges (DNDs) aﬀect approximately 15% of infants and 
adolescents worldwide, producing signiﬁcant impairment in cogni)on, communica)on, 
adap)ve behavior, and psychomotor skills. Au)sm spectrum (ASD) has an es)mated global 
prevalence of 0.77%, with higher rates among males. 
In Argen)na, a DND rate of 20% has been reported through screening methods. Adap)ve 
behavior, deﬁned as the conceptual, social, and prac)cal skills needed to func)on in the 
everyday environment, is a fundamental predictor of future quality of life and can be 
modiﬁed through speciﬁc evidence-based interven)ons. 
The study aims to know the impact of the Sen)do® Model on the gain of adap)ve behaviors, 
which is important for ﬁve fundamental reasons: 
1. To improve the quality of life of infants, families and professionals who live with 
neurodevelopmental challenges. 
2. Inform parents about the eﬃcacy and eﬀec)veness of the interven)ons oﬀered. 
3. Provide evidence for government agencies, public and private policymakers, 
prepaid, and health insurance companies. 
4. Contribute with a manualized interven)on program that is contextually appropriate 
to the strengths and challenges of a low- and middle-income country. 
5. Provide evidence-based data on whether the programs created ﬁt the popula)on 
needs and cultural par)culari)es of the region. 
1.2 Descrip(on of the Sen(do ́s® Model 
The Sen)do's Model (SM) is an innova)ve proposal for the understanding and interven)on 
of DNDs, epistemologically based on a transcomplex perspec)ve that integrates the 
postulates of Morín (1996) complex thinking with Nicolescu's (1996; 2025) 
transdisciplinarity. 
Evidence-Based Frameworks: 
1. Applied Behavior Analysis (ABA): Interven)ons with extensive empirical support, 
recognized as evidence-based prac)ce for ASD and DND (Hagopian et al., 2015). 
2. Ayres Sensory Integra(on (ASI): Validated prac)ce for children in ASD aged 4-12 
years (Schoen et al., 2019). 
3. Psychoimmunoneuroendocrinology (PINE): Stress medicine approach during 
cri)cal periods of neurodevelopment (Danese & Lewis, 2017). 
Opera(onal Structure of the Sen(do ́s® Model: 
MS is a model that integrates diverse frameworks and paradigms for the interven)on of 
children in ASD and other related DNDs, their signiﬁcant caregivers and intervening 
therapists. To achieve this purpose, it is based on a transcomplex perspec)ve that seeks 

prac)cal ac)ons of a science with consciousness and materializes a mul)dimensional bio-
neuro-sensory-psycho-social-spiritual-occupa)onal-nutri)onal-ecological 
approach 
structured in a hierarchical architecture of four interrelated opera)onal components.  
1. NINE INTEGRATED DIMENSIONS (mul)dimensional framework): MS encompasses 
nine dimensions for comprehensive understanding, reasoning, and interven)on: 
Biological Dimension: Biological evolu)on accounts for how human behavior and gene)cs 
impact the way we act; it studies the morphophysiology and behavior of organic structures; 
it includes epigene)c regula)on that allows the forma)on of diﬀerent phenotypes 
depending on the environment. 
Neurological Dimension: Examines the neurobiological aspects and func)oning of the 
central nervous system in human development. 
Sensory Dimension: The sensory processing of the central nervous system, especially the 
ves)bular, propriocep)ve, and tac)le senses that impact adap)ve behavior. 
Psychological Dimension: The cogni)ve, emo)onal, and mental processing aspects of 
development. 
Social Dimension: The social interac)ons, family dynamics, and rela)onal contexts that 
inﬂuence development. 
Spiritual Dimension: Integrates concepts such as ikigai (life purpose) and belief systems as 
therapeu)c resources for psychological well-being and vital meaning. 
Occupa(onal Dimension: The systema)c study of human behavior from children's play to 
adult work; the daily and family ac)vi)es that inﬂuence health and well-being. 
Nutri(onal Dimension: Neuronutri)on as a science that links food to health and disease; it 
studies how nutrients aﬀect the nervous system, behavior, and cogni)on. 
Ecological Dimension: The study of the rela)onship between organisms and their 
environment; it includes factors such as screen )me, physical ac)vity, parental care, and 
social interac)ons that inﬂuence development. 
2. SIX FUNDAMENTAL PREMISES (conceptual principles): 
1. Behavioral Premise, which evaluates how the child and the family behave, cons)tu)ng 
the diagnos)c entry point by observing behavioral pacerns and rela)onal dynamics. 
2. Gene(c/Epigene(c Imprin(ng premise, which examines how gene)cs inﬂuences 
observed behavior, recognizing that family prac)ces can modulate gene expression. 
3. Organic Condi(on Premise, which iden)ﬁes which medical condi)ons of the child 
(allergies, gastrointes)nal disorders, sleep disturbances) impact their behavior and family 
func)oning. 
4. Sensory Proﬁle Premise, which assesses how the central nervous system processes 
sensory informa)on and how the family responds to these manifesta)ons. 
5. Environmental Premise, which analyzes how environmental, family, and social factors 
inﬂuence the child's development. 

6. Premise of Belief Systems and Spirituality, which integrates spiritual strengths as 
therapeu)c resources for the family to ﬁnd meaning in the process of accompanying the 
child's development, genera)ng deep and las)ng systemic transforma)ons. 
3. THREE THEORETICAL POSTULATES (theore)cal bases): 
1. Postulate of Neurobehavior - Human behavior is the observable manifesta)on of how 
the central nervous system processes and integrates sensory informa)on from the body and 
environment, where altera)ons in these processes are expressed as atypical behavioral 
pacerns. 
2. Postulate of the Func(on of Behaviors - All behavior fulﬁlls a speciﬁc adap)ve func)on 
and cons)tutes operant responses controlled by con)ngencies of three terms (antecedent-
behavior-consequence) that can be iden)ﬁed and modiﬁed by func)onal analysis. 
3. Postulate of the Possibility of Condi(oning Unhealthy Responses - Maladap)ve 
responses 
and 
problem 
behaviors 
are 
manifesta)ons 
of 
altera)ons 
in 
the 
psychoneuroimmunoendocrine systems that can be modiﬁed by interven)ons that 
modulate the ac)va)on of the hypothalamic-pituitary-adrenal axis and the autonomic 
nervous system during cri)cal periods of development. 
4. THREE INTEGRATED STRATA (levels of interven)on): 
Stratum I: Childhoods in ASD and other associated DNDs - The central core that 
encompasses 
childhoods 
with 
au)sm 
spectrum 
characteris)cs 
and 
other 
neurodevelopmental challenges, focusing on teaching strategies to gain adap)ve skills. 
Stratum II: Meaningful Caregivers – Parents and caregivers, recognizing that child 
development occurs within family systems where caregivers' responsiveness is cri)cal to 
adap)ve func)oning. 
Stratum III: Therapists (Professionals) Involved - The health and educa)on professionals who 
implement the model, requiring specialized training and interdisciplinary and 
transdisciplinary collabora)ve work. 
This opera)onal structure reﬂects the complexity and conceptual richness of the Sen)do 
Model,® providing the complete theore)cal framework that supports the en)re 
transcomplex interven)on methodology. In order to teach infants to use strategies that 
contribute to the gain of adap)ve behaviors/skills through a guided, organized, and 
systema)c process, evidence-based, and goal-driven by goals that families consider 
meaningful to achieve greater well-being in children's daily lives and family dynamics,  
considering the holis)c integra)on of the nine dimensions, based on the six premises and 
the three theore)cal postulates. 
2. OBJECTIVES 
2.1 Main Objec(ve 

To describe the impact of the Sen)do® Model on the adap)ve behaviors of children 
between 3 and 7 years old, on the au)sm spectrum and other associated 
neurodevelopmental challenges, who acend the Sen)do's Therapeu)c Organiza)on, during 
a period of 17 weeks. 
2.2 Secondary Objec(ves 
1. Implement the syllabus protocol and MS programs in par)cipa)ng families 
2. Apply protocols in children between 3-7 years of age with associated ASD and DND 
3. Evaluate agreed goals using Goal Acainment Scaling (GAS) at three )me points 
4. Iden)fy domains and subdomains of acquired adap)ve behaviors 
5. To analyze results of the Family Outcome Survey (FOS) in signiﬁcant caregivers 
6. Perform comprehensive sta)s)cal analysis of the results obtained 
3. HYPOTHESIS 
The Sen)do ́s® Model provides tools that promote and develop adap)ve behaviors in 
children in the AE and other associated DNDs, simultaneously enhancing the competencies, 
conﬁdence and care skills of families towards their children. 
4. STUDY DESIGN 
4.1 Type of Study 
Prospec)ve longitudinal interven)on study, pretest-poscest design with follow-up. Non-
concurrent single-subject design, mul)ple baseline, repeated measures between subjects. 
4.2 Design Jus(ﬁca(on 
This design cons)tutes a useful ﬁrst step in the research of treatment eﬃcacy, seeking to 
establish a rela)onship between individualized interven)on and change in expected results. 
The subject acts as his or her own control, comparing performance before, during, and aker 
the interven)on. 
The non-concurrent design oﬀers greater ﬂexibility in clinical selngs by not requiring 
concurrent collec)on of baseline data. When replicated with mul)ple subjects, it provides 
a systema)c and cost-eﬀec)ve method for replica)ng results. 
4.3 Dura(on of the Study 
• 
Recruitment period: 2023-2024. 
• 
Dura(on of individual par(cipa(on: 17 weeks. 
• 
Ac(ve interven(on: 14 weeks. 
• 
Post-interven(on follow-up: 3 weeks (3 weeks without interven)on from week 15 
to week 17). 

4.4 Study (meline 
4.4.1 Schedule of general ac(vi(es 
Ac#vi#es 
2023 
2024 
2025 
Update bibliography 
✓ 
✓ 
✓ 
Transmit the methodology of the Sen6do ́s Model to the par6cipa6ng 
professionals 
✓ 
✓ 
✓ 
Select Popula6on 
✓ 
✓ 
✓ 
Sign consents 
✓ 
✓ 
✓ 
Implement the syllabus protocol and the Modelo Sen6do's programs in 
families 
✓ 
✓ 
✓ 
Administer the scales: Vineland-3, GAS, FOS 
✓ 
✓ 
✓ 
Apply the syllabus protocol and MS programs 
✓ 
✓ 
✓ 
Remanage: GAS Scale, FOS Scale, Vineland-3 
- 
✓ 
✓ 
Sta6s6cally analyze the results obtained 
- 
✓ 
✓ 
Report Results Achieved 
- 
- 
✓ 
Thesis wri6ng 
- 
- 
✓ 
4.4.2 Timeline of the phased study 
Phase 
Ac#vity 
Dura#on 
Responsible 
Prepara6on 
Staﬀ Training 
4 weeks 
PI 
Recruitment 
Iden6ﬁca6on and Consent 
12 months 
Clinical Team 

Phase 
Ac#vity 
Dura#on 
Responsible 
Interven6on 
MS Implementa6on 
14 weeks/par#cipant 
Cer6ﬁed Therapists 
Tracking 
Post-interven6on evalua6ons 
3 weeks/par#cipant 
Evaluators 
Analysis 
Sta6s6cal analysis and repor6ng 
8 weeks 
Biosta6s6cian + PI 
4.4.3 Gan_ Chart - Integrated Timeline 
Legend of Study Phases 
●●●● 
PREPARATION 
●●●● 
RECRUITMENT 
●●●● 
INTERVENTION 
●●●●  
FOLLOW-UP 
●●●●  
ANALYSIS 
Integrated Timeline (2023-2025) 
Phase/Ac#vity 
2023Q4 
2024 
2025T1-T3 
 
Oct-Dec 
Jan-Mar 
Apr-Jun 
Jul-Sep 
Oct-Dec 
Jan-Sep 
PREPARATION 
●●●● 
- 
- 
- 
- 
- 
• Professional training 
●●●● 
- 
- 
- 
- 
- 
RECRUITMENT 
- 
●●●● 
●●●● 
●●●● 
●●●● 
- 
• Par/cipant iden/ﬁca/on 
- 
●●●● 
●●●● 
●●●● 
●●●● 
- 
• Informed consents 
- 
●●●● 
●●●● 
●●●● 
●●●● 
- 
INTERVENTION 
- 
●●●● 
●●●● 
●●●● 
●●●● 
●●●● 
• Sen/do Model App's® 
- 
●●●● 
●●●● 
●●●● 
●●●● 
●●●● 

Phase/Ac#vity 
2023Q4 
2024 
2025T1-T3 
 
Oct-Dec 
Jan-Mar 
Apr-Jun 
Jul-Sep 
Oct-Dec 
Jan-Sep 
• Regular evalua/ons 
(Vineland-3, GAS, FOS) 
- 
●●●● 
●●●● 
●●●● 
●●●● 
●●●● 
TRACKING 
- 
- 
- 
- 
- 
●●●● 
• Post-interven/on 
evalua/ons 
- 
- 
- 
- 
- 
●●●● 
ANALYSIS 
- 
- 
- 
- 
- 
●●●● 
•Sta/s/cal analysis 
- 
- 
- 
- 
- 
●●●● 
• Wri/ng of reports and 
theses 
- 
- 
- 
- 
- 
●●●● 
Note: The schedule shows the main ac1vi1es of the study. The recruitment and interven1on 
phases may overlap since a non-concurrent single-subject design is implemented. The 
es1mated total dura1on of the study is 36 months (2023-2025). 
5. PARTICIPANTS 
5.1 Target Popula(on 
Universe: Children aged 3-7 years with ASD and other associated DNDs who acend Sen)do's 
Therapy Organiza)on CAIP&CICI (Comprehensive Pediatric Care Center and Intensive 
Behavioral Interven)on Center), Comodoro Rivadavia, Chubut, Argen)na. 
Sample: All eligible childhoods during the study period. 
Selec(on: Non-probabilis)c convenience, non-random, voluntary. 
5.2 Eligibility Criteria 
Inclusion Criteria: 
1. Informed consent signed by the parent or guardian. 
2. Comply with the requirements for execu)ve admission. 
3. Meet the DSM-V diagnos)c impression criteria for neurodevelopmental disorders: 

o Intellectual disability (ID); developmental global delay (MDR) or psychomotor 
delay (RPM). 
o Communica)on disorders: language disorders (SL), speech disorders, social 
communica)on disorder (SCD), childhood-onset dysﬂuency. 
o Au)sm spectrum disorder (ASD). 
o Acen)on deﬁcit hyperac)vity disorder (ADHD). 
o Motor developmental disorders: developmental coordina)on disorder 
(BDD), stereotypic movement disorder, )c disorders, Tourece's disorder (TT), 
chronic )c disorder (TT), transient )c disorder 
o Speciﬁc learning disorders (PAC). 
4. Respond to the GAS, Vineland-3 and FOS scales in therapeu)c admission. 
5. Willingness of signiﬁcant caregivers to accompany in the interven)on process, for 
twelve sessions according to the syllabus protocol. 
Exclusion Criteria: 
1. Childhoods that exceed the age of 7 years in the period of study. 
2. Children diagnosed with neurological or gene(c diseases, brain injury, visual, 
auditory or motor sensory deﬁcits. 
3. Children who are under the guardianship of the Argen(ne State. 
6. INTERVENTION 
6.1 Descrip(on of the Sen(do ́s® Model 
The interven)on is based on a ﬁdelity procedure based on three structural elements: 
6.1.1 Syllabus Protocol Manual Opera)onal systema)za)on in seven procedural phases: 
1. Execu)ve admission. 
2. Therapeu)c admission. 
3. GAS Administra)on. 
4. Nutri)onal proﬁle evalua)on. 
5. Therapeu)c evalua)on/probing. 
6. Comprehensive therapeu)c interven)on. 
7. Re-administra)on scales. 
6.1.2 Professional Educa(on and Training 
• 
Level 1: Theore)cal-technical training (7 modules). 
• 
Level 2: Theore)cal-experien)al training (12 topics). 
• 
Level 3: Interdisciplinary and Transdisciplinary Training Program (90 hours). 
6.1.3 Physical Space and Materials 
• 
Conﬁgura)on according to neuroplas)city principles. 
• 
4 diﬀeren)ated therapeu)c environments. 
• 
Materials categorized by developmental domains. 

• 
Compliance with speciﬁc loyalty measures. 
6.2 Interven(on Mode 
• 
Dura(on: 14 weeks. 
• 
Intensity: 60 minutes daily, 4 days a week. 
• 
Modality: Intensive comprehensive behavioral interven)on. 
• 
Family inclusion: Chaining and fading system in 12 structured sessions. 
7. OUTCOME VARIABLES AND MEASURES 
7.1 Primary Variable 
Change in Vineland-3 Adap)ve Behavior Composite Score (AUC) from baseline to week 17. 
7.2 Secondary Variables 
• 
Scores by Vineland-3 domains (Communica)on, Daily Life, Socializa)on). 
• 
GAS scores for individualized goals. 
• 
FOS scores for family competencies. 
• 
Skill maintenance (week 15 vs. week 17). 
8. MEASURING INSTRUMENTS 
8.1 Vineland Adap+ve Behavior Scales, Third Edi+on (Vineland-3) 
Descrip(on: The Comprehensive Interview, Parent Form (IPPC) contains 502 items to 
measure ﬁve domains: Communica)on, Daily Living Skills, Socializa)on, Motor Skills, and 
Maladap)ve Behavior. 
Domains evaluated: 
• 
Communica(on: Recep)ve (39 items), Expressive (49 items), Wricen (38 items) 
subdomains. 
• 
Daily Living Skills: Personal (55 items), Domes)c (30 items), Community (58 items) 
subdomains. 
• 
Socializa(on: Interpersonal Rela)ons (43 items), Play and Leisure (36 items), Coping 
Skills (33 items) subdomains. 
Administra(on (me: 10-40 minutes depending on the form and age. 
 Psychometric proper(es: Internal consistency coeﬃcients ≥0.90, test-retest reliability 0.64-
0.92. 
8.2 Goal A_ainment Scaling (GAS) 
Descrip(on: A method of personalized scales that allow quan)fying progress towards 
speciﬁc collabora)vely deﬁned objec)ves. 
Modiﬁed measuring system: 5-point scale adapted for EA and DND: 

• 
-2 = current performance levels (baseline). 
• 
-1 = progress. 
• 
0 = expected level of results. 
• 
+1 = somewhat more than expected. 
• 
+2 = much more than expected. 
Conversion: Kiresuk-Sherman formula for standardized T-scores (M=50, SD=10). 
8.3 Family Outcome Survey (FOS) 
Descrip(on: Scale that measures results in competencies, conﬁdence and skills of caring for 
families towards their children with special needs. 
Administra(on: Caregiver self-report (15 minutes). 
Internal consistency: α = 0.88  
9. STUDY PROCEDURES 
9.1 Sampling Periods 
Phase 1 - PRE-TEST (Baseline - Week 0): 
• 
Control period during therapeu)c admission. 
• 
Vineland-3 administra)on, FOS to signiﬁcant parents/caregivers. 
• 
Elabora)on of collabora)ve GAS objec)ves (parents-professionals). 
• 
Complete interdisciplinary diagnos)c evalua)on. 
Phase 2 - INTERVENTION (Weeks 1-14): 
• 
Implementa)on of the Sen)do ́s® Model according to the syllabus protocol. 
• 
4 weekly sessions of 60 minutes. 
• 
Daily record of progress by professionals. 
• 
Inclusion of caregivers (12 structured sessions), gradual fading of their par)cipa)on 
in the sessions. 
Phase 3 - POST-TEST (Week 15): 
• 
Re-administra)on of Vineland-3, FOS, GAS evalua)on aker 14 weeks of interven)on. 
• 
Skills maintenance evalua)on. 
Phase 4 - FOLLOW-UP (Week 17): 
• 
Third administra)on Vineland-3. 
• 
Evalua)on of GAS (parent-professional) objec)ves aker two weeks without 
interven)on. 
• 
Post-interven)on sustainability analysis. 
• 
Return to usual interven)on. 
10. ETHICAL CONSIDERATIONS 
10.1 Ethical and Legal Aspects 

The study complies with: 
• 
Approval of the Bioethics, Science and Technology Commicee (CBCyT) of the 
University Ins)tute in Health Sciences - H. A. Barceló Founda)on. 
• 
Principles of the Declara)on of Helsinki. 
• 
Standards of Good Clinical Prac)ce. 
• 
Na)onal Law 25,326 on the protec)on of personal data. 
• 
ID code NCT06477666 in Clinical Trials. 
10.2 Informed Consent 
Informa(on provided includes: 
1. Objec)ves and importance of the project. 
2. Study procedures in three )me phases through scales administered by health 
professionals. 
3. Evalua)on scales used (Vineland-3, GAS, FOS) and their purpose. 
4. Voluntary par(cipa(on and right of withdrawal without penalty. 
5. Absolute conﬁden(ality - iden)ty will not be revealed to any person. 
6. There will be no dis(nc(on in the type of interven)on oﬀered, whether or not you 
decide to par)cipate in the study. 
7. Contact 
informa)on: 
Barbara 
Muriel 
Thomas, 
tomasbarbara@gmail.com, 
2974635050 phone. 
8. Contact the Ethics Commicee for inquiries and/or complaints. 
Speciﬁc documents: 
• 
Par(cipant Informa(on Sheet: Complete document with details of the study. 
• 
Informed Consent of Parents/Legal Representa(ve: Formal authoriza)on for 
par)cipa)on. 
• 
Informed Assent of the Child: Adapted document with drawings and photos for 
children's understanding. 
10.3 Data Conﬁden(ality 
• 
Coding: Data anonymized by coding in a research ﬁle. 
• 
Restricted access: Only researchers approved with professional secrecy. 
• 
Secure storage: Network computers with access by personal key. 
• 
Transmission to third par(es: Only encrypted data with no direct iden)ﬁable 
informa)on. 
• 
Destruc(on: All data will be destroyed/deleted once the results are published. 
• 
Storage: For the )me necessary for research development (es)mated 24 months). 
• 
Rights: Par)cipants may exercise rights of access, rec)ﬁca)on, limita)on, dele)on, 
portability and opposi)on. 
 

SECTION II: STATISTICAL ANALYSIS PLAN (SAP) 
1. STATISTICAL OBJECTIVES 
1.1 Primary Objec(ve 
To evaluate the sta)s)cal change in the Vineland-3 Adap1ve Behavior Composite (ABC) 
composite score from baseline (week 0) to ﬁnal follow-up (week 17) in par)cipants who 
received interven)on with the Sen)do® Model. 
1.2 Secondary Objec(ves 
1. To compare scores by domains of the Vineland-3 (Communica)on, Daily Life, 
Socializa)on) between the three )me points. 
2. Evaluate changes in GAS (Goal Acainment Scaling) scores for individualized goals. 
3. To analyze changes in FOS (Family Outcome Survey) scores for family competencies. 
4. Determine skill maintenance between week 15 and week 17 (non-interven)on 
period). 
2. STUDY DESIGN AND GENERAL CONSIDERATIONS 
2.1 Type of Design 
• 
Design: Prospec)ve longitudinal interven)on, pretest-poscest with follow-up. 
• 
Conﬁgura(on: Non-concurrent single subject design, mul)ple baseline. 
• 
Analysis: Repeated intra-subject measures with three )me points. 
2.2 Popula(on Analysis 
Target popula(on: n = 24 es)mated par)cipants who meet inclusion criteria and complete 
evalua)ons in the three planned )me points. 
Pre-established criteria for inclusion in analysis: 
• 
Par)cipants aged 3-7 years with a conﬁrmed diagnosis of ASD and/or associated 
DND according to DSM-V 
• 
Signed informed consent 
• 
Comple)on of the 14-week interven)on protocol 
• 
Complete data in the three temporary evalua)ons 
3. DEFINITIONS OF VARIABLES AND OUTCOME MEASURES 
3.1 Primary Variable 
Variable: 
Change 
in 
ABC 
Vineland-3 
composite 
score. 
Opera(onal deﬁni(on: Diﬀerence between ABC score at week 17 minus ABC score at week 
0. 

Measurement scale: Con)nuous (standard score with mean = 100, SD = 15). 
Measurement (me: Week 0 (baseline), Week 15 (post-interven)on), Week 17 (follow-up). 
3.2 Secondary Variables 
3.2.1 Dominios Vineland-3 
• 
Communica(on: Sum of subdomains Recep)ve, Expressive, Wricen. 
• 
Daily Life: Sum of subdomains Personal, Domes)c, Community. 
• 
Socializa(on: Sum of subdomains Interpersonal Rela)onships, Play and Leisure, 
Coping Skills. 
• 
Scale: Standard scores (mean = 100, SD = 15). 
3.2.2 Goal A_ainment Scaling (GAS) 
• 
Objec(ves 1, 2 and 3: Individually deﬁned by family and therapists. 
• 
Scale: 5-point ordinal (-2 to +2). 
• 
Conversion: T-scores using the Kiresuk-Sherman formula (mean = 50, SD = 10). 
3.2.3 Family Outcome Survey (FOS) 
• 
Deﬁni(on: Family caregiving competencies, conﬁdence, and skills. 
• 
Scale: Con)nuous (total score). 
3.3 Characteriza(on Variables 
• 
Age (full years at admission). 
• 
Sex (male/female). 
• 
Primary diagnosis (associated ASD, DND). 
• 
Adherence to the protocol (percentage of completed sessions). 
4. SPECIFIC STATISTICAL METHODS 
4.1 Descrip(ve Analysis 
4.1.1 Quan(ta(ve variables (Vineland-3, FOS): 
• 
Arithme)c mean and standard devia)on. 
• 
Median and interquar)le range (Q1-Q3). 
• 
Minimum and maximum values. 
• 
95% conﬁdence intervals for the mean. 
• 
Graphical representa)on using boxplots and )me proﬁle graphs. 
4.1.2 Ordinal variables (GAS): 
• 
Absolute and rela)ve frequencies by category. 
• 
95% conﬁdence intervals for propor)ons. 
• 
Median and quar)le. 
• 
Bar charts by )me frame. 
4.1.3 Categorical variables: 

• 
Absolute and rela)ve frequencies. 
• 
95% conﬁdence intervals for propor)ons. 
4.2 Inferen(al Analysis 
4.2.1 Primary Variable Analysis 
Main method: One-factor ()me) repeated measures ANOVA with three levels. 
• 
Intrasubject factor: Time (3 levels: week 0, 15, 17). 
• 
Dependent variable: ABC Vineland-3 score. 
• 
Null hypothesis: H₀: μ₀ = μ₁₅ = μ₁₇ (there are no diﬀerences between moments). 
• 
Alterna(ve hypothesis: H₁: At least one mean diﬀers. 
Post-hoc comparisons: Bonferroni's method for mul)ple comparisons: 
• 
Week 0 vs. Week 15. 
• 
Week 0 vs. Week 17. 
• 
Week 15 vs. Week 17. 
4.2.2 Analysis of Secondary Variables 
Quan(ta(ve variables (Vineland-3 Domains, FOS): 
• 
Repeated measures ANOVA (procedure iden)cal to primary variable). 
• 
Bonferroni correc)on for mul)ple comparisons. 
• 
Analysis of planned contrasts (linear and quadra)c). 
Ordinal variables (GAS): 
• 
Friedman's test for repeated measures (k = 3 moments). 
• 
Dunn's post-hoc comparisons with Bonferroni's correc)on. 
• 
Analysis by individual objec)ve (Objec)ve 1, 2, and 3). 
4.3 Veriﬁca(on of Sta(s(cal Assump(ons 
4.3.1 For Repeated Measures ANOVA: 
Assump(on of Normality: 
• 
Primary method: Shapiro-Wilk test (n ≤ 50 appropriate for n=24). 
• 
Complementary methods: 
o Kolmogorov-Smirnov test. 
o Visual inspec)on using Q-Q plots. 
o Histograms with normal curve superimposed. 
• 
Pre-established criteria: p > 0.05 to accept normality according to protocol. 
• 
Planned ac(on if violated: Logarithmic transforma)on or use of non-parametric 
methods according to protocol speciﬁca)ons. 
Sphericity Case: 
• 
Method: Mauchly test for covariance matrix sphericity. 
• 
Pre-established criteria: p > 0.05 to accept sphericity according to protocol. 
• 
Planned ﬁxes if violated: 

o Greenhouse-Geisser (epsilon < 0.75). 
o Huynh-Feldt (epsilon > 0.75). 
o Lower limit (very small epsilon). 
Homoscedas(city Case: 
• 
Method: Levene test for equality of variances. 
• 
Applica(on: A residual diﬀerences between pairs of measurements. 
• 
Pre-established criteria: p > 0.05 to accept homoscedas)city according to protocol. 
4.3.2 For non-parametric tests (GAS): 
• 
Independence: Veriﬁca)on of the intrasubject design. 
• 
Ordinal scale: Conﬁrma)on of the ordinal nature of GAS scores. 
4.4 Handling Missing Data 
4.4.1 Planned Primary Analysis (Completed): 
• 
Inclusion only of par)cipants with complete data at the three planned )me points. 
• 
Systema)c descrip)on of excluded par)cipants and reasons according to protocol. 
4.4.2 Pre-established Sensi(vity Analysis: 
• 
Planned Method 1: Last Observed Carried Out (LOCF). 
• 
Scheduled Method 2: Worst-case scenario analysis (no change assignment). 
• 
Protocolized comparison: Evalua)on of agreement between methods according to 
a pre-established plan. 
4.5 Signiﬁcance Criteria and Adjustments for Mul(ple Comparisons 
4.5.1 Level of Signiﬁcance: 
• 
Primary analysis: α = 0.05 (bilateral). 
• 
Conﬁdence intervals: 95%. 
4.5.2 Adjustments for Mul(ple Comparisons: 
• 
Within each variable: Bonferroni correc)on for post-hoc comparisons. 
• 
Among secondary variables: No adjustment (exploratory analysis). 
• 
Number of comparisons by ANOVA: 3 post-hoc comparisons. 
Bonferroni adjustment formula: α_ajustado = α / number of comparisons = 0.05 / 3 = 
0.0167. 
4.6 Calcula(on of Eﬀect Sizes 
4.6.1 For Repeated Measures ANOVA: 
• 
Par(al eta square (ηp²): To assess magnitude of eﬀect 
o Small: ηp² = 0.01 
o Median: ηp² = 0.06 
o Large: ηp² = 0.14 
4.6.2 For post-hoc comparisons: 

• 
Cohen's d: For diﬀerences between pairs of means 
o Small: d = 0.20 
o Median: d = 0.50 
o Large: d = 0.80 
Formula: d = (μ₁ - μ₂) / spooled 
4.6.3 For non-parametric tests: 
• 
r eﬀect: r = Z/√N for Friedman test 
o Small: r = 0.10 
o Median: r = 0.30 
o Large: r = 0.50 
5. SPECIFIC ANALYSIS PROCEDURES 
5.1 Planned Sequence of Analysis 
Step 1: Planned descrip)ve analysis of baseline characteris)cs and systema)c evalua)on of 
missing data. 
Step 2: Protocolized veriﬁca)on of sta)s)cal assump)ons for each variable according to 
prespeciﬁed methods. 
Step 3: Planned analysis of primary variable (ABC Vineland-3): 
• 
Repeated measures ANOVA according to protocol speciﬁca)ons. 
• 
Post-hoc comparisons condi)oned to signiﬁcant F. 
• 
Preset calcula)on of eﬀect sizes. 
Step 4: Scheduled analysis of quan)ta)ve secondary variables (Vineland-3 domains, FOS): 
• 
Repeated measures ANOVA for each variable according to protocol. 
• 
Post-hoc comparisons with prespeciﬁed Bonferroni correc)on. 
Step 5: Planned ordinal secondary variable (GAS) analysis: 
• 
Friedman's test for each objec)ve according to design. 
• 
Dunn's post-hoc comparisons according to protocol. 
Step 6: Preset sensi)vity analysis for missing data based on speciﬁed methods. 
Step 7: Planned synthesis of ﬁndings and interpreta)on according to pre-established 
criteria. 
5.2 Clinical Interpreta(on Criteria 
5.2.1 Primary Variable (AUC Vineland-3): 
• 
Clinically signiﬁcant change: ≥ 1.0 SD (≥ 15 points). 
• 
Moderate change: 0.5-0.99 SD (7.5-14.9 points). 
• 
Minimum change: 0.2-0.49 SD (3-7.4 points). 
• 
No change: < 0.2 SD (< 3 points). 
5.2.2 GAS Variables: 

• 
Complete success: T-score ≥ 60 (level +1 or +2). 
• 
Par(al success: T-score 50-59 (expected level 0). 
• 
No change: T-score 40-49 (level -1). 
• 
Setback: T-score < 40 (level -2). 
6. STATISTICAL SOFTWARE AND QUALITY CONTROL 
6.1 Sooware 
• 
Main program: SPSS version 30.0 
• 
Add-on sooware: Microsok Excel for data management 
• 
Version control: Daily database backup 
6.2 Planned Data Quality Control 
• 
Programmed double keying: For 10% of randomly selected data 
• 
Systema(c Range Checking: Iden)fying Values Outside Expected Ranges 
• 
Protocolized Internal Consistency: Checking for Consistency Between Related 
Variables 
• 
Outlier detec(on: Iden)ﬁca)on by preset Tukey method (IQR × 1.5) 
6.3 Planned Analysis Documenta(on 
• 
SPSS Syntax: Preset Command File to Use 
• 
Output Log: Scheduled documenta)on of all sta)s)cal outputs 
• 
Methodological decisions: Systema)c recording of all decisions according to 
protocol 
7. ADDITIONAL SENSITIVITY ANALYSIS 
7.1 Analysis by Planned Exploratory Subgroups 
• 
Age: Programmed comparison between group 3-5 years vs. 6-7 years. 
• 
Diagnosis: Pre-established ASD vs. other DNDs. 
• 
Adherence: Planned comparison ≥80% vs. <80% of completed sessions. 
7.2 Scheduled Inﬂuen(al Case Analysis 
• 
Pre-established methods: Cook distance, standardized residuals. 
• 
Predeﬁned criteria: Values > 3 SD considered atypical. 
• 
Planned analysis: Repe))on of main analyses excluding inﬂuen)al cases according 
to protocol. 
8. HANDLING DEVIATIONS FROM THE PLAN 
8.1 Minor devia(ons 
• 
Adjustments to assump)on veriﬁca)on methods. 
• 
Changes in graphical methods of presenta)on. 

• 
Documenta(on: In sta)s)cal report. 
8.2 Major devia(ons 
• 
Changes in primary analysis methods. 
• 
Modiﬁca)ons in variable deﬁni)ons. 
• 
Approval: Required from the principal inves)gator. 
• 
Documenta(on: Protocol amendment. 
9. STATISTICAL ANALYSIS SCHEDULE 
9.1 Data Cleansing Phase (Week 1-2) 
• 
Completeness and consistency veriﬁca)on. 
• 
Iden)ﬁca)on and resolu)on of discrepancies. 
• 
Final database prepara)on. 
9.2 Descrip(ve Analysis Phase (Week 3) 
• 
Basal characteris)cs. 
• 
Veriﬁca)on of sta)s)cal assump)ons. 
9.3 Inferen(al Analysis Phase (Week 4-5) 
• 
Primary variable analysis. 
• 
Analysis of secondary variables. 
• 
Sensi)vity analysis. 
9.4 Interpreta(on Phase (Week 6) 
• 
Synthesis of results. 
• 
Prepara)on of tables and ﬁgures. 
• 
Sta)s)cal report wri)ng 
10. RECOGNIZED STATISTICAL LIMITATIONS 
10.1 Design Limita(ons 
• 
Absence of a control group: Limita)on for causal inferences. 
• 
Intrasubject design: Possible eﬀects of prac)ce or )me. 
• 
Sample size: n=24 limits sta)s)cal power for subgroup analysis. 
10.2 Instrument Limita(ons 
• 
Local valida(on: Vineland-3 and FOS not validated in the Argen)ne popula)on. 
• 
Interpreta(on: Cau)on required in absolute magnitudes. 
• 
Strategy: Focus on consistent pacerns of change. 
10.3 Considera(ons of Mul(ple Comparisons 
• 
Secondary variables: Increase in type I error without global adjustment. 
• 
Interpreta(on: Secondary outcomes such as exploratory/hypothesis generators. 
 

ANNEXES 
ANNEX A: CONSENT AND ASSENT DOCUMENTS 
Oﬃcial informed consent and assent documents include: 
1. Par(cipant Informa(on Sheet: A detailed document that explains all aspects of the 
study. 
2. Informed Consent of Parents/Legal Representa(ve: Formal document of 
authoriza)on. 
3. Informed Assent of the Child: Document adapted with visual elements for child 
understanding. 
These documents guarantee: 
• 
Full understanding of the study by parents/caregivers. 
• 
Voluntary par)cipa)on without coercion. 
• 
Protec)on of the rights of par)cipa)ng minors. 
• 
Compliance with interna)onal ethical standards. 
• 
Conﬁden)ality and protec)on of personal data according to Argen)ne regula)ons.