Trial · NCT04968522
FASST - Fetal Alcohol Spectrum Stimulant Trial
NCT04968522, Phase 4, Unknown, Monash Medical Centre
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. FASST - Fetal Alcohol Spectrum Stimulant Trial. Trials, record NCT04968522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04968522
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FASST - Fetal Alcohol Spectrum Stimulant Trial
- NCT number
- NCT04968522
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Monash Medical Centre
- Conditions
- Fetal Alcohol Spectrum Disorders
- Interventions
- Methylphenidate Hydrochloride, Placebo, Methylphenidate hydrochloride, Methylphenidate Hydrochloride 18 MG, Dexamphetamine sulfate
- First posted
- 2021-07-20
- Last updated
- 2022-12-13
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38631835 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Rapid Visual Information Processing | Primary outcome | ConductCognition |
| Tower Planning | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04968522
GET https://conductscience.org/api/trials/v1/NCT04968522/registered?page=2