NCT07392489

Decreasing Harms and Improving Child Health

Decreasing Harms and Improving Child Health: An Intervention to Reduce Inappropriate Use of Antipsychotics and Polypharmacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Glyn Jones-Elwyn · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prescriptions to children for antipsychotic medications and polypharmacy have steeply increased in recent years. Parents, schools, and clinicians may hold unrealistic expectations for these medications and desire quick relief, but do not attend to the concerning side effects or long-term morbidities. In children, the majority (75%) of antipsychotic use and 100% of polypharmacy (three or more psychiatric medications at the same time), is off-label, or not approved by the FDA for the purpose. These practices are risky, commonly leading to side effects like substantial weight gain, metabolic abnormalities, neurocognitive impairments, sedation, tremor, somnolence, and restlessness. Parents are often unaware of the risks and seldom feel fully included in decisions to use these medications. Government agencies, regulatory bodies, and media outlets have voiced significant concerns over the increased use of these medications. Clinicians and parents are interested in reducing or stopping these medications (deprescribing), but one stated barrier is the lack of guidance on how to safely deprescribe. To address this gap, our team has developed the AWARE intervention, which incorporates two tools: 1) a patient-facing decision aid called an Option GridTM that guides both clinicians and patients/parents through a shared decision-making process about mental health treatment options; and 2) a structured protocol that provides detailed, evidence-based guidance on how to deprescribe (e.g., dose reduction rates, monitoring, safety planning) psychotropic medications in youth receiving either an off-label antipsychotic medication and/or three or more psychiatric medications concurrently. The proposed study will refine the intervention and evaluate it with 40 children receiving off-label antipsychotics or polypharmacy in two outpatient mental health clinics in the northeast.

Conditions

• Psychotropic Drugs
• Psychiatric Drugs
• Children
• Shared Decision Making
• Patient Decision Aid

Interventions

Type	Name	Description
BEHAVIORAL	AWARE Shared Decision Making Medication Review	Participants, caregivers and clinicians use a shared decision making approach supported by a patient decision aid and smartphone app to review the youth's medications. This review includes discussing the original reason for the medication, how helpful the medication is, whether the youth has any side effects, the balance of side effects with effectiveness, and whether the medication is still needed. After reviewing all medications, a shared decision is made about whether to keep all medications the same or to attempt to deprescribe one of them. If the choice is to deprescribe, intervention includes a detailed, structured deprescribing protocol to support the prescribing clinician.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-12-12
• Completion: 2025-02-12
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

4 sites across 1 country: United States