Trial · NCT04968522
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ADHD symptoms - teacher report - between placebo and stimulant | Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total) | ADHD symptoms will be measured using the Conners 3rd Edition-Teacher (Conners 3-T), for 6-18 year old's and the Conners Early Childhood teachers/childcare providers (full length) form for participants 2-6 years. Each item is rated on a Likert scale from 0 to 3 (0=never or rarely; 1=sometimes; 2=often; 3=very often). Test- retest values for the Conners scales indicate excellent temporal stability (ranging from .73 to 1.00). The T-score is norm referenced, with a mean of 50. The average range falls within one standard deviation of the mean (i.e., between 40 and 59). A higher score indicates more elevated symptoms. T score Guideline 70+Very Elevated Score 65-69 Elevated Score 40-59 Average score 60-64 High average score \< 40 Low score. Investigators will examine Inattentive and Hyperactivity/Impulsivity Symptom Scales. Symptoms indicated for each subscale are summed to get total. |
| Primary | Change in ADHD symptoms - parent report - between placebo and stimulant | Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total) | ADHD symptoms will be measured using the Conners 3rd Edition-Parent (Conners 3-P), for 6-18 year old's and the Conners Early Childhood parent (full length) form for participants 2-6 years. Each item is rated on a Likert scale from 0 to 3 (0=never or rarely; 1=sometimes; 2=often; 3=very often). Test- retest values for the Conners scales indicate excellent temporal stability (ranging from .73 to 1.00). The T-score is norm referenced. The average range falls within one standard deviation of the mean (i.e., between 40 and 59). A higher score indicates more elevated symptoms. T score Guideline 70+Very Elevated Score 65-69 Elevated Score 40-59 Average score 60-64 High average score \< 40 Low score. Investigators will examine Inattentive and Hyperactivity/Impulsivity Symptom Scales. Symptoms indicated for each subscale are summed to get the total. |
| Primary | Change in spatial working memory - between placebo and stimulant | Day 3 of each trial week (8 weeks total) | Spatial Working Memory (SWM) task from the Cambridge Neuropsychological Test Automated Battery. SWM is a component of cognitive executive function which is measured by SWM task of CANTAB between the errors. The ability to retain spatial information and manipulate remembered items in working memory will be measured with the SWM task of CANTAB which is self-ordered and assesses the individual's ability to strategise. Between search errors will be analysed. Scores are raw scores, with no normative data available. Higher error score indicated poorer performance. Scale does not have a maximum range. |
| Primary | Change in Visual Information Processing - between placebo and stimulant | Day 3 of each trial week (8 weeks total) | Rapid Visual Information Processing (SOC) from Cantab. SOC Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. The participant must move the balls in the bottom display to copy the pattern shown in the top display. The balls are moved one at a time by selecting the required ball, then selecting the position to which it should be moved. The participant is instructed to make as few moves as possible to match the two pattern. The outcome measure of this subtest is the number of problems completed, regardless of whether the maximum moves limit was reached on any problem. |
| Secondary | Change in child problem behaviour rating- between placebo and stimulant | Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total) | Top Problem Rating. This will be used as a brief but robust measure of child emotional and behavioural difficulties as rated by the parent. Top Problems Assessment (TPA) is a brief, idiographic procedure that allows clinicians and researchers to identify problems of children that are especially important from the perspective of the caregiver. The severity of these problems, once identified, will monitored daily. The overall severity of problem rating (0 - 4) between placebo and active medication arms will be used as an indicator of problem worsening or improving. as one index of whether improvement is occurring. A higher problem rating indicates greater perceived difficulties. |
| Secondary | Change in functional Impairment- between placebo and stimulant | Daily for 5 week days (Monday - Friday) of each trial week (8 weeks total) | Impairment resulting from ADHD symptoms. This scale contains the items that are most likely to represent the participant's target of treatment. The instrument uses a Likert scale such that any item rating 2 or 3 is clinically impaired. The scale is scored generating the total score. When defining impairment for DSM-IV, any domain with at least two items scored 2, one item scored 3 or a mean score \>1.5 is impaired. |
| Secondary | Difference in side effects during placebo and stimulant phase | Day 5 of each trial week (8 weeks total) | Investigators will monitor side effects of the placebo and active medication using the Barkley Side Effects Rating Scale (17 symptoms; 0 = absent, severity rated from 1 to 9). Parent ratings of side effects for the drug and placebo conditions will be described using the mean total side effect rating for each condition. |
| Secondary | Trial feasibility - recruitment rate | End of 8 month active trial phase | Feasibility of the study (n-of-1 design) will be explored using trial recruitment rate across the trial from study start to study close. Investigators will calculate recruitment feasibility as the percentage of eligible participants agreeing to participate. A higher percentage will indicate greater participation. |
| Secondary | Trial feasibility - completion rate | End of 8 month active trial phase | Feasibility of the study (n-of-1 design) will be explored using completion rates across the trial from study start to study close. Completion rate will be the percentage of enrolled participants who complete the trial. A higher percentage will indicate greater participation. |
| Secondary | Compliance | End of 8 month active trial phase | Investigators will inspect participant medication diaries, to calculate treatment compliance. Non-compliance will be defined as missing more than one or more days of the active drug or placebo condition. |
| Secondary | Assessment completion rate | End of 8 month active trial phase | Investigators will calculate the percentage of outcome assessments completed by each participant to examine assessment feasibility of the study design. |
| Secondary | Data completion reason | End of 8 month active trial phase | Investigators will also examine reasons for incomplete outcome data. |
| Secondary | Adverse events | End of 8 month active trial phase | Adverse events (AE's) will be coded using the, Medical Dictionary for Regulatory Activities (MedDRA), and calculated once each per participant. We will describe the total number of AE's across the trial. |
| Other | Rate of change of prescribed stimulant | End of trial (8 weeks) | Participant's paediatrician will rate any change in medication practice, immediately post-trial. This will capture the rate of this change in medication as a result of the N-of-1 trial data over the whole study. |
| Other | Attention Deficit Hyperactivity Disorder subtype classification | Baseline | Conners 3 parent and teacher ratings will be used to classify child ADHD subtype (ADHD inattentive type, ADHD Hyperactive-Impulsive type, ADHD Combined type) according to DMS related symptom count cut-offs (At least 6 out of 9 symptoms) for each subtype or combined type. |
| Other | Attention factor 1 (selective) | Baseline | The Tea-Ch measures four factors of child attention. Selective, or focused attention will be measures using the Sky Search task. This measure provides both raw score and scaled scores for each of the subtests. We will use age and gender based scaled scores for selective attention outcome. Scaled scores have a mean of 10 and standard deviation of 2. A lower score indicates greater impairment in the attentional factor. |
| Other | Attention factor 2 (sustained) | Baseline | The Tea-Ch measures four factors of child attention. Sustained attention will be measures using the Score! task. This measure provides both raw score and scaled scores for each of the subtests. We will use age and gender based scaled scores for sustained attention outcome. Scaled scores have a mean of 10 and standard deviation of 2. A lower score indicates greater impairment in the attentional factor. |
| Other | Attention factor 3 (divided) | Baseline | The Tea-Ch measures four factors of child attention. Switching attention will be measures using the Sky Search DT task. This measure provides both raw score and scaled scores for each of the subtests. We will use age and gender based scaled scores for divided attention outcome. Scaled scores have a mean of 10 and standard deviation of 2. A lower score indicates greater impairment in the attentional factor. |
| Other | Attention factor 4 (alternating) | Baseline | The Tea-Ch measures four factors of child attention. Alternating attention (i.e. switching focus from one stimuli to another) will be measures using the Creature counting task. This measure provides both raw score and scaled scores for each of the subtests. We will use age and gender based scaled scores for alternating attention outcome. Scaled scores have a mean of 10 and standard deviation of 2. A lower score indicates greater impairment in the attentional factor. |
| Other | Cognitive ability level | Baseline | Child intellectual functioning will be assessed at baseline using age based normed Full Scale IQ from age appropriate Weschler scales (WPPSI-IV or WISC-V). The median Full Scale IQ is centered at 100, with a standard deviation of 15. A higher score indicates greater cognitive ability. |
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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