Psychotropic DrugsNCT07392489
Decreasing Harms and Improving Child Health
A study testing AWARE Shared Decision Making Medication Review in people with Psychotropic Drugs and Psychiatric Drugs, run by Glyn Jones-Elwyn at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psychotropic Drugs, Psychiatric Drugs, Children
- What is being tested?
- AWARE Shared Decision Making Medication Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Nov 2023to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cayuga County Community Mental Health Center
Auburn, New York, 13021
Dartmouth College
Hanover, New Hampshire, 03755
Dartmouth Health
Lebanon, New Hampshire, 03766
Clinton County Mental Health & Addiction Services
Plattsburgh, New York, 12903
About this study
Official title: Decreasing Harms and Improving Child Health: An Intervention to Reduce Inappropriate Use of Antipsychotics and Polypharmacy
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.
Read more
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:
- Medication review using the handout \& making a decision
- 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.
Read the 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
- Being tested
- AWARE Shared Decision Making Medication Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARE Shared Decision Making Medication ReviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AWARE Shared Decision Making Medication Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 30-week follow-up
Secondary outcomes (9)
Number of medications (baseline)
The dose of each psychotropic medication the participant was taking was extracted from the electronic medical record and a simple count of medications was calculated. This served as the basis for measuring dose-weighted medications at 18- and 30-week follow-up.
Measured: Baseline
Dose-weighted number of medications (follow-ups)
The investigators calculated dose-weighted medications instead of a simple medication count to reflect reductions in dose (as well as discontinuation of medications). The number of dose-weighted medications at each follow-up point was calculated as a sum of the proportion of the current daily dose of each medication compared to the sum of the baseline daily doses of those medications. For example, if a participant was taking 100 mgs of trazodone and 25 mgs of zoloft daily at baseline and 50 mgs of trazodone and 25 mgs of zoloft daily at 18-week follow-up, the dose-weighted number of medications at follow-up would be 1.5 (whereas a straight count of medications at follow-up would be 2).
Measured: 18- and 30-week follow-up
Medication-related reactions
To facilitate data collection in this routine community setting, the investigators created the Medication Reactions Checklist (MRC), which categorizes medication reactions by body system instead of medication class. It includes all of the side effects assessed by the Psychotropic Medication Monitoring Checklist (PMMC), which is a widely-used research tool. Clinicians completed the MRC during clinic visits based on feedback gathered from the participant and caregiver.
Measured: At each clinical visit (weeks 4-18)
Study-related adverse events
Events meeting the NIH definition of adverse events and serious adverse events that were deemed not likely to be study related.
Measured: Ongoing monitoring throughout study participation (baseline through 30-week follow-up)
Columbia Impairment Scales, Parent Version (CIS-P)
The Columbia Impairment Scales, Parent Version (CIS-P) is a 13-item survey completed by the caregiver or parent that measures child functioning in four specific areas: relations with family members, relations with peers, academic or occupational functioning, and involvement in activities or interests. The scale is a 0-4 Likert scale, totals ranging from 0-52, where higher scores mean higher impairment.
Measured: Baseline, 18-, and 30-week follow-up
Columbia Impairment Scales, Youth Version (CIS-Y)
The Columbia Impairment Scales, Youth Version (CIS-Y) is a 13-item survey completed by the caregiver or parent that measures child functioning in four specific areas: relations with family members, relations with peers, academic or occupational functioning, and involvement in activities or interests. The scale is a 0-4 Likert scale, totals ranging from 0-52, where higher scores mean higher impairment.
Measured: Baseline, 18-, and 30-week follow-up
Modified Overt Aggression Scale (MOAS)
The Modified Overt Aggression Scale (MOAS) is a 4-item caregiver-completed measure used to capture the frequency of verbal, property-related, physical, and self-directed aggressive behaviors. Each category is scored from 0 to 4 and multiplied by weights to calculate a total weighted score ranging from 0 to 100. Higher scores demonstrate higher aggression.
Measured: Baseline, 18-, and 30-week follow-up
Clinical Global Impression Scales - Severity (CGI-S)
The Clinical Global Impression Scales - Severity (CGI-S) is a single-item, clinician rated measure of the extent of impairment caused by mental illness symptoms that is widely utilized in pediatric clinical trials and clinical settings. It is a 7-point rating used by clinicians to assess a patient's current mental health severity (1 = normal; 7 = most severely ill).
Measured: Baseline, 18-, and 30-week follow-up
Clinical Global Impression Scales - Improvement (CGI-I)
The Clinical Global Impression Scales - Improvement (CGI-I) is a single-item, clinician rated measure of the degree of improvement in mental illness symptoms compared to a previous assessment point, with 1 being "very much improved" and 7 being "very much worse." Like the CGI-S, it is widely utilized in pediatric clinical trials and clinical settings.
Measured: Baseline, 18-, and 30-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start16 Nov 2023
- Primary completion12 Dec 2024
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotropic DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyn Jones-Elwyn
- Sponsor type
- University, hospital or other
- Collaborators
- Charles H. Hood Foundation, Dartmouth-Hitchcock Medical Center, Cayuga County Community Mental Health Center, Clinton County Mental Health & Addiction Services
- Responsible party
- Sponsor-investigator, Glyn Jones-Elwyn, Trustees of Dartmouth College
- Investigators
- Glyn Elwyn, MD, PhD, MSc, Principal investigator, The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392489
- Sponsor's protocol ID
- 23-10-216
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have consent from participants to share their data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Harms and Improving Child Health: An Intervention to Reduce Inappropriate Use of Antipsychotics and Polypharmacy
- ClinicalTrials.gov ID
- NCT07392489
- Acronym / sponsor ID
- 23-10-216
- Conditions
- Psychotropic Drugs, Psychiatric Drugs, Children, Shared Decision Making, Patient Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Glyn Jones-ElwynUniversity, hospital or other
- Collaborators
- Charles H. Hood Foundation, Dartmouth-Hitchcock Medical Center, Cayuga County Community Mental Health Center, Clinton County Mental Health & Addiction Services
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Medication review using the handout \& making a decision
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AWARE Medication Review | Experimental | Behavioral: AWARE Shared Decision Making Medication ReviewAll eligible participants and their parent/caregiver take part in the AWARE intervention - a shared decision making comprehensive medication review with the participant's clinician. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWARE Shared Decision Making Medication ReviewParticipants, 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. | Behavioural | AWARE Medication Review |
Primary outcome
Feasibility
Time frame: Baseline through 30-week follow-up
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.
9 secondary outcomes
Number of medications (baseline)
Time frame: Baseline
Dose-weighted number of medications (follow-ups)
Time frame: 18- and 30-week follow-up
Medication-related reactions
Time frame: At each clinical visit (weeks 4-18)
Study-related adverse events
Time frame: Ongoing monitoring throughout study participation (baseline through 30-week follow-up)
Columbia Impairment Scales, Parent Version (CIS-P)
Time frame: Baseline, 18-, and 30-week follow-up
Columbia Impairment Scales, Youth Version (CIS-Y)
Time frame: Baseline, 18-, and 30-week follow-up
Modified Overt Aggression Scale (MOAS)
Time frame: Baseline, 18-, and 30-week follow-up
Clinical Global Impression Scales - Severity (CGI-S)
Time frame: Baseline, 18-, and 30-week follow-up
Clinical Global Impression Scales - Improvement (CGI-I)
Time frame: Baseline, 18-, and 30-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. We do not have consent from participants to share their data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glyn Elwyn, MD, PhD, MSc principal investigator
The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARE Shared Decision Making Medication Review in people with Psychotropic Drugs and Psychiatric Drugs, run by Glyn Jones-Elwyn at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Baseline through 30-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.