Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism

The ABC-C is a caregiver-completed questionnaire with 58 items, divided into five subscales. The ABC-I (Irritability) subscale includes 15 items that assess emotional and behavioral symptoms of ASD, such as aggression toward others, deliberate self-injury, temper tantrums, depressed mood, and rapidly shifting moods. Scores on this subscale range from 0 to 45, with higher scores indicating greater severity. Change from baseline to Week 8 is reported, with lower scores reflecting clinical improvement.

The VABS-3 Socialization domain measures interpersonal relationships, play and leisure, and coping skills, reflecting the individual's ability to engage in age-appropriate social interactions. Higher scores indicate better adaptive social functioning.

The SRS-2 measures the severity of social impairment associated with autism spectrum disorder. It includes five subscales: Social Awareness (8 items), Social Communication (22 items), Social Cognition (12 items), Social Motivation (11 items), and Restricted Interests and Repetitive Behavior (12 items). Two summary scores are derived: the Total Score (sum of all five subscales) and the Social Communication and Interaction (SCI) score, which combines the four social subscales excluding Restricted Interests and Repetitive Behavior. The SCI and RRB correspond to the two DSM-5 symptom domains of autism spectrum disorder. Raw scores range from 65 to 260; higher scores indicate greater severity of social impairment.

Participants experiencing at least one adverse event that newly appeared or worsened after treatment initiation. Adverse events are graded as mild, moderate, or severe; hospitalizations are documented as serious adverse events; causality is categorized from not related to definitely related.

Number of participants with clinically significant abnormal values in complete blood count (CBC), liver transaminases, or total bilirubin levels, as determined by the investigator.

Difference between baseline and week 8 body mass index (kg/m²)

CGI-I is a clinician rating of overall change from baseline; scores range from 1 to 7, with higher scores indicating worse outcome; anchors: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; 7 very much worse.

CGIC (CaGC) is a caregiver rating of overall change from baseline; scores range from 1 to 7, with higher scores indicating worse outcome; anchors: 1 very much improved; 2 much improved; 3 minimally improved; 4 no change; 5 minimally worse; 6 much worse; 7 very much worse.

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The VABS-3 Communication domain measures receptive, expressive, and written language skills. Higher Communication scores indicate better adaptive functioning

The VABS-3 Maladaptive Behavior domain measures internalizing, externalizing, and other maladaptive behaviors. Higher Maladaptive Behavior scores indicate greater difficulties.

The EDI measures the intensity and reactivity of emotional responses, reflecting difficulties with emotion regulation; scores range from 0 to 120, with higher scores indicating greater emotion dysregulation.

The MAP-DB assesses temper loss, aggression, noncompliance, and impulsivity, capturing the frequency and severity of disruptive behaviors. Higher scores indicate greater disruptive behavior.

The AIM assesses the frequency and impact of core autism symptoms in daily life. Higher scores indicate greater symptom frequency and impact.

The QOLA Parent version includes Part A, parents' overall perception of their quality of life, and Part B, the impact of ASD symptoms on parents' quality of life; higher scores indicate better quality of life. Total scores: Part A ranges from 28 to 140, with higher scores reflecting better perceived parental quality of life; Part B ranges from 20 to 100, with higher scores indicating that the child's autism-related difficulties are perceived as less problematic for the parent.

he CSHQ assesses common sleep problems in children across multiple domains; scores range from 33 to 99, with higher scores indicating a greater likelihood of sleep problems.

This inventory assesses the presence and severity of gastrointestinal problems such as constipation, diarrhea, abdominal pain, and bloating. Higher scores indicate greater gastrointestinal symptom burden.

The BRIEF evaluates executive functioning in daily life, including working memory, inhibitory control, and cognitive flexibility. Higher scores indicate greater executive dysfunction.