Decreasing Harms and Improving Child Health
Completed · Not applicable
Conditions studied: Psychotropic Drugs, Psychiatric Drugs, Children, Shared Decision Making, Patient Decision Aid
In brief
The investigators are doing this study because they know from research and talking with caregivers that kids can be on a bunch of medications, and it's hard to keep track of what the medications are for and whether or not they are helping. The other thing the investigators know is that some medications have very few side effects while others have many side effects, some of which can cause real health problems (severe weight gain, diabetes). Once someone is on a medication, they often just keep taking it without thinking much about whether they still need it. the investigators are doing this study to look at the process of reviewing medications with the help of a handout that shows basic information about the most common types of medications, making a decision about keeping medications the same or lowering one, and following people to see how it goes. If the caregiver and youth decide to lower a medication, the investigators have created a structured process for their child's prescriber to do this slowly and safely. Slowly means kids are not likely to have any bad reactions. This process can be used to just lower the dose of a medication or to stop it altogether. This is called the AWARE intervention and it has 2 parts: 1. Medication review using the handout \& making a decision 2. Prescribers' guide about lowering meds slowly for those who choose to do this The caregivers/youth do not have to lower a medication to be in the study.
Key facts
- Study ID
- NCT07392489
- Run by
- Glyn Jones-Elwyn
- People needed
- 31
- Starts
- 2023-11-16
- Expected to finish
- 2025-02-12
- Last updated by the study team
- 2026-02-06
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Youth will be aged 6-17 years;
- They will have been prescribed an off-label antipsychotic or polypharmacy (3 or more medications) for 3 months and be stable for 3 months (i.e. no hospitalizations or residential care).
- The parents or legal guardians of eligible children will be aged 18 years or older and capable of providing informed consent.
You may not qualify if…
- Children with an acute clinical or medical crisis, or a major substance use disorder will not be eligible.
- Children using an antipsychotic who have a diagnosis of psychotic disorder, bipolar affective disorder, autism spectrum disorder, or Tourette's disorder will not be eligible, as FDA approval exists for these situations.
- Youth who are pregnant will not be eligible.
Where it is running
- Dartmouth College — Hanover, New Hampshire, United States
- Dartmouth Health — Lebanon, New Hampshire, United States
- Cayuga County Community Mental Health Center — Auburn, New York, United States
- Clinton County Mental Health & Addiction Services — Plattsburgh, New York, United States
Full record on ClinicalTrials.gov
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