Trial · NCT07300956
Treating Young Children With Attention Deficit Hyperactivity Disorder
NCT07300956, Phase 4, Recruiting, Children's Hospital Medical Center, Cincinnati
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating Young Children With Attention Deficit Hyperactivity Disorder. Trials, record NCT07300956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07300956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating Young Children With Attention Deficit Hyperactivity Disorder
- NCT number
- NCT07300956
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 370 participants, estimated
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- Interventions
- Guanfacine (GUA), Methylphenidate (MPH)
- First posted
- 2025-12-24
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression-Improvement | From enrollment to the end of the 16-week medication treatment. | The Clinical Global Impression-Improvement scale is a seven-point rating tool that evaluates how a participant's Attention-Deficit/Hyperactivity Disorder symptoms have changed since their baseline measurement. Although this scale can be used for other mental health conditions, in this study it is applied specifically to Attention-Deficit/Hyperactivity Disorder. A score of "1" indicates "very much improved," while a score of "7" indicates "very much worse." Higher scores reflect a worse outcome. |
| Secondary | Medication discontinuation within 16 weeks | From medication randomization assignment to the end of the 16-week medication treatment. | The percent of participants who discontinue medication prior to 16 weeks will be measured to assess treatment acceptability. |
| Secondary | Vanderbilt Attention-Deficit/Hyperactivity Disorder Parent Rating Scales | From enrollment to the end of the 16-week medication treatment. | This caregiver-completed questionnaire includes 55 items across three sections. The first section contains 18 Attention-Deficit/Hyperactivity Disorder symptom items rated on a three-point scale from "Never" (0) to "Very Often" (3), with Attention-Deficit/Hyperactivity Disorder total symptom scores ranging from a minimum of 0 to a maximum of 54. The second section contains 29 items related to behavioral and mental health comorbidity symptoms (e.g., oppositional defiant, disordered conduct, anxiety, and mood symptoms) rated on a three-point scale from "Never" (0) to "Very Often" (3), with comorbidity total symptom scores ranging from a minimum of 0 to a maximum of 87. The third section includes eight performance/impairment-related items rated on a five-point scale from "Excellent" (1) to "Problematic" (5), with performance/impairment total scores ranging from 8 to 40. On all sections, higher scores indicate more severe symptoms and/or greater impairment. |
| Secondary | Vanderbilt Attention-Deficit/Hyperactivity Disorder Teacher Rating Scales | From enrollment to the end of the 16-week medication treatment. | This measure, completed by teachers (if applicable), includes 43 items divided into three sections. The first section contains 18 Attention-Deficit/Hyperactivity Disorder symptoms items rated on a three-point scale from "Never" (0) to "Very Often" (3), with Attention-Deficit/Hyperactivity Disorder total symptom scores ranging from a minimum of 0 to a maximum of 54. The second section contains 17 items related to behavioral and mental health comorbidity symptoms (e.g., oppositional defiant, disordered conduct, anxiety, and mood symptoms) rated on a three-point scale from "Never" (0) to "Very Often" (3), with comorbidity total symptom scores ranging from 0 51. The third section includes eight performance/impairment-related items rated on a five-point scale from "Excellent" (1) to "Problematic" (5), with performance/impairment total scores ranging from 8 to 40. On all sections, higher scores indicate more severe symptoms and/or greater impairment. |
| Secondary | Parenting Stress Index Short Form | From enrollment to the end of the 16-week medication treatment. | Caregivers will complete the Parenting Stress Index Short Form, which consists of 36 items. Each item is rated on a five-point scale ranging from 1= "Strongly Disagree" to 5= "Strongly Agree." Total scores can range from 36 to 180, with higher scores indicating greater levels of parenting stress. |
| Secondary | Affective Reactivity Index - Caregiver | From enrollment to the end of the 16-week medication treatment. | This measure, completed by caregivers, includes 7 items. For each item, the caregiver responds by answering 0="Not True," 1="Somewhat True," or 2="Certainly True." Total scores range from 0 to 14. Higher scores indicate higher levels of irritability, whereas lower scores indicate lower levels of irritability. |
| Secondary | Affective Reactivity Index - Teacher | From enrollment to the end of the 16-week medication treatment. | This measure, completed by teachers (if applicable), includes 7 items. For each item, teachers respond by answering 0="Not True," 1="Somewhat True," or 2="Certainly True." Total scores range from 0 to 14. Higher scores indicate higher levels of irritability, whereas lower scores indicate lower levels of irritability. |
| Secondary | Pittsburgh Side Effects Rating Scale | From enrollment to the end of the 16-week medication treatment. | The Pittsburgh Side Effects Rating Scale will be completed by caregivers and will measure safety and tolerability. This version of the scale has been adapted to include one additional item related to daytime sleepiness, a known side effect of Guanfacine, resulting in a total of 14 items. Each item is rated on a scale from 0 to 3, where 0 means the side effect is not present, 1 means the side effect is mild, 2 means the side effect is moderate, and 3 means the side effect is severe. Total scores range from 0 to 42, with 0 indicating no side effect symptoms and higher scores indicating more/worse side effects. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT07300956
GET https://conductscience.org/api/trials/v1/NCT07300956/registered