Decreasing Harms and Improving Child Health

NCT07392489 | Completed DMC

• 1 other identifier: 23-10-216
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief 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. 1.Medication review using the handout \& making a decision
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

  The investigators measured feasibility by examining the number of people who were approached, enrolled, and completed data collection. The investigators also included the number of enrolled participants who activated their smartphone app account and accessed various sections/resources in the app.

  Baseline through 30-week follow-up

Secondary Outcomes (9)

• Number of medications (baseline)

  Baseline

• Dose-weighted number of medications (follow-ups)

  18- and 30-week follow-up

• Medication-related reactions

  At each clinical visit (weeks 4-18)

• Study-related adverse events

  Ongoing monitoring throughout study participation (baseline through 30-week follow-up)

• Columbia Impairment Scales, Parent Version (CIS-P)

  Baseline, 18-, and 30-week follow-up

Other Outcomes (4)

• Deprescribing choice

  ~4 weeks post-baseline

• Modified Perceived Involvement in Care Scale (M-PICS)

  Baseline, 18-, and 30-week follow-up

• CollaboRATE

  -4, -8, and -12 weeks

Study Arms (1)

AWARE Medication Review

EXPERIMENTAL

All eligible participants and their parent/caregiver take part in the AWARE intervention - a shared decision making comprehensive medication review with the participant's clinician.

Behavioral: AWARE Shared Decision Making Medication Review

Interventions

AWARE Shared Decision Making Medication Review BEHAVIORAL

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.

AWARE Medication Review

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Charles H. Hood Foundation: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Cayuga County Community Mental Health Center: collaborator
• Clinton County Mental Health & Addiction Services: collaborator
• Glyn Jones-Elwyn: lead

Study Sites (4)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Dartmouth Health

Lebanon, New Hampshire, 03766, United States

Location

Cayuga County Community Mental Health Center

Auburn, New York, 13021, United States

Location

Clinton County Mental Health & Addiction Services

Plattsburgh, New York, 12903, United States

Location

Study Officials

• Glyn Elwyn, MD, PhD, MSc

  The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 6, 2026
• Study Start: November 16, 2023
• Primary Completion: December 12, 2024
• Study Completion: February 12, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)