Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Change in Mullen; Visual Reception Sub-scale Scores, Pre- and Post-Intervention	Initial evaluation and at the end of the 3 month trial	The Mullen Scales of Early Learning (MULLEN) Visual reception subscale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Primary	Change in Mullen; Fine Motor Sub-scale Scores, Pre- and Post-Intervention	Baseline and 3 months	The Mullen Scales of Early Learning (MULLEN) Fine motor scale raw scores range from Minimum=0 to Maximum=49. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Primary	Change in Mullen; Receptive Language Subscale Scores, Pre- and Post-Intervention	Baseline and 3 months	The Mullen Scales of Early Learning (MULLEN) Receptive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Primary	Change in Mullen, Expressive Language Sub-scale Scores, Pre- and Post-Intervention	Baseline and 3 months	The Mullen Scales of Early Learning (MULLEN) Expressive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Secondary	Change in VABS: Motor Skills Domain Scores, Pre- and Post-Intervention	Baseline evaluation and at the end of the 3 month study	Vineland Adaptive Behavior Scales-II (VABS): Motor Skills Domain Scores individual items are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Motor Skills Domain raw scores range from: Minimum=0 to Maximum=100. A higher score is a better outcome.
Secondary	Change in VABS:Daily Living Skills Domain Scores, Pre- and Post-Intervention	Baseline and at the end of the 3 month trial	Vineland Adaptive Behavior Scales-II (VABS): Daily Living Skills Domain individual items are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. The Daily Living Skills Domain measures personal behavior as well as domestic and community interaction skills. Daily Living Skills Domain raw scores range from Minimum=0 to Maximum=218.
Secondary	Change in VABS: Socialization Domain Scores, Pre- and Post-Intervention	Baseline and at the end of the 3 month trial	Vineland Adaptive Behavior Scales-II (VABS): Socialization Domain. Critical behaviors are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Socialization Domain raw scores range from: Minimum=0 to Maximum=152. A higher score is a better outcome.
Secondary	Change in VABS:Communication Domain Scores, Pre- and Post-Intervention	Baseline and at the end of the 3 month trial	Vineland Adaptive Behavior Scales (VABS)-II Communication Domain Scores. The Communication Domain evaluates the receptive, expressive, and written communication skills of the child. Critical behaviors in each Subdomain item are rated as 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Communication Domain raw scores range from: Minimum=0 to Maximum=198. A higher score is a better outcome.
Secondary	Change in Ghuman-Folstein Screen for Social Interaction (SSI) Score, Pre- and Post-Intervention.	Initial evaluation and at the end of the 3 month study. The test lasts 45 minutes	The Ghuman-Folstein Screen for Social Interaction (SSI) assesses the change in behavior and temperament dysregulation as a total score. The score ranges from 0-162, with 0 being most Impaired /has the strongest autism features and 162 having no impairment/no autism features.
Secondary	Change in Rett Syndrome Behavior Questionnaire Score, Pre- and Post-Intervention	Initial evaluation and at the end of the 3 month study	The Rett Syndrome Behavior Questionnaire (RSBQ) total score was assessed. The total score ranges from 0 to 90, with 0 exhibiting no Rett syndrome related symptoms and 90 showing the greatest amount of symptoms (worse outcome).
Other	Change in PedsQL School Functioning Subscale Score, Pre- and Post-Intervention	Baseline evaluation and at the end of the 3 month study	Pediatric Quality of Life Inventory (PedsQL version 4). School Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).
Other	Change in PedsQL Total Score, Pre- and Post-Intervention	Baseline evaluation and at the end of the 3 month study	Pediatric Quality of Life Inventory (PedsQL version 4) total score. Each item is rated on a 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The Total Score is the sum of all the items over the number of items answered on all the Scales. Higher scores indicate better HRQOL.
Other	Change in PedsQL Social Functioning Subscale Score, Pre- and Post-Intervention	Baseline and at the end of the 3 month trial	Pediatric Quality of Life Inventory (PedsQL version 4). Social Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).
Other	Change in PedsQL Emotional Functioning Subscale Score, Pre- and Post-Intervention	Baseline evaluation and at the end of the 3 month study	Pediatric Quality of Life Inventory (PedsQL version 4). Emotional Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).
Other	Change in PedsQL Physical Functioning Subscale Score, Pre- and Post-Intervention	Initial evaluation and at the end of the 3 month study	Pediatric Quality of Life Inventory (PedsQL version 4). Physical Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).
Other	Change in Seizure Frequency, Pre- and Post-Intervention, 0-4 Year Age Group	Baseline evaluation and at the end of the 3 month study	Change in Frequency of seizure count baseline to follow-up for children aged 0-4 years
Other	Change in Seizure Frequency, Pre-and Post-Intervention, 5-10 Year Age Group	Baseline evaluation and at the end of the 3 month study	Change in Frequency of seizures baseline to follow-up for children aged 5-10 years

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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