ADHD Trial, Recruiting NCT06350292 Sponsor: University of South Florida Condition: ADHD
Back to Adhd

ADHD Trial, Recruiting

NCT06350292
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 8 to 12 who have previously been diagnosed with Oppositional Defiant Disorder (ODD) and also have trouble sleeping
  • Both the child and their parent or guardian are comfortable speaking and reading English
  • The child has had difficulty falling asleep, staying asleep, or waking too early in the morning — either noticed by the child or a parent — for 3 months or more
  • The sleep problems are causing issues during the day, such as with mood, thinking, socialising, or schoolwork
  • Sleep tracking records (using a diary and a wrist monitor worn at home) show the child is taking more than 30 minutes to fall asleep, waking during the night, or waking too early on at least 6 nights before the trial begins

Who may not be able to join:

  • Cases where the parent or guardian is not able to give formal consent, or the child is not able to give their own agreement to take part
  • Families who are not willing to be randomly assigned to a treatment group
  • Children or parents who are already taking part in another research study involving random assignment
  • Parents or guardians who have a cognitive impairment that would prevent them from filling out forms or carrying out the treatment steps
  • Children who have an untreated medical condition, including other sleep disorders such as sleep apnoea, epilepsy, psychotic disorders, thoughts of suicide, or frequent sleep disturbances like sleepwalking
  • Children who are taking medications (other than stimulants, sleep medications, or melatonin) that are known to affect sleep
  • Children who are currently receiving a non-medication treatment for sleep problems — such as talking therapy (including CBT) — outside of this trial
  • Cases where the parent reports the child would be unable to wear a heart monitor or wrist sleep tracker, for example due to extreme sensitivity or behavioural difficulties
  • Any other circumstances that the trial site determines would make participation difficult or unsuitable (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 8139748110

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of South Florida
Registry
ClinicalTrials.gov
Start date
1 April 2024
Est. completion
1 August 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Child Daily Sleep Diaries; Parent Daily Sleep Diaries

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov