Child Behavior DisordersVillageWhereNCT03065517

VillageWhere: Innovative Mobile Technology for Youth With Conduct Disorder and Their Parents

A study testing VillageWhere App in people with Child Behavior Disorders, run by Evidence-Based Practice Institute, Seattle, WA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 years and older
Conditions the study is for: Child Behavior Disorders
What is being tested?: VillageWhere App
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 226 participants
Where: 1 siteUnited States
Study dates: 16 Jul 2018to 28 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Parent Inclusion Criteria:

English speaking
owns an Android or iPhone-based smartphone with a data plan, is the primary user of the phone, and uses it on a daily basis
primary caregiver and has legal guardianship (custody) of a youth aged 13-18 with conduct disorder.

Parent Exclusion Criteria:

has an open case with child protective services
does not have legal custody of the youth
participated in Phase I project and/or the Phase II formative evaluation

Youth Inclusion Criteria:

English speaking
possesses and is the primary user of an Android or iPhone-based smartphone with a data plan
resides in the same household as the linked parent participant at least five days a week
actively (past two weeks) engaging in clinically significant conduct-problem behaviors Note: Youth who have "stepped down" from a residential treatment or juvenile justice facility in the past month but may not have exhibited conduct problem behavior within the past 2 weeks will also be eligible, provided other criteria are met.

Youth Exclusion Criteria:

resides with a secondary caregiver 3 or more days each week

Trial locations and contacts

1 site in 1 country.

United States1 site

Evidence-Based Practice Institute
Seattle, Washington, 98144

Other trials in United States

About this study

Official title: Using Mobile Technology to Enhance MST Outcomes

The goal of this Phase II Small Business Innovation Research (SBIR) is to develop, evaluate, and commercialize a linked parent-youth mobile app system, VillageWhere, to support the key treatment targets of evidence-based treatments for youth with conduct disorders: clear parental expectations, parental monitoring, discipline consistency, and parental support, while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors. When used in conjunction with an evidence-based treatment for delinquent youth, VillageWhere could help reduce treatment length and cost. When provided in non-evidence-based clinical settings, VillageWhere may increase access to state-of-the-art clinical techniques to those who might not otherwise receive them. Investigators will conduct usability and acceptability tests of new features with target-end-users (youth and their parents) and key stakeholders (i.e., probation officers, clinic administrators). Once usability and acceptability is achieved, investigators will conduct a 16-week randomized controlled trial (RCT) comparing VillageWhere to an attention-control (placebo) mobile app. We expect that across four time points, VillageWhere use will result in greater improvements in parent management practices and youth autonomy support, parent-youth communication and connectedness, youth intrinsic motivation for positive behavior, and youth conduct problems than the placebo. The RCT will occur with 100 parent-youth dyads recruited from various treatment and probation settings, and represent clinically-significant conduct-problems of various clinically-significant severity levels.

Conditions: Child Behavior Disorders
Being tested: VillageWhere App, Attention-Control Placebo App
Keywords: Criminal Justice, Juvenile Delinquency
Medical subject headings: Child Behavior Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VillageWhere AppDevice
VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.
Attention-Control Placebo AppDevice
Mobile phone app for use on both Android and iOS platforms.

Study groups in NCT03065517
Study group	Role	What they receive
VillageWhere App	Experimental	Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial. The app is designed to be used several times throughout each day. Receives: Device: VillageWhere App
Attention-Control Placebo App	Placebo comparator	Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial. Receives: Device: Attention-Control Placebo App

What is being measured

The primary outcome is the main question the study is designed to answer.

Child Behavior Checklist (CBCL)
Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 36) and aggressive behavior (minimum of 0, maximum of 34). Higher scores are a worse outcome.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Youth Self-Report (YSR)
Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 34) and aggressive behavior (minimum of 0, maximum of 36). Higher scores indicate worse outcomes.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Self-Report of Delinquent Behavior Scale
Assesses youth delinquent behaviors. Contains one main scale: the general delinquency scale. There are also several subscales: the status offenses (e.g., ran away from home, purchased alcohol, truant) subscale, the school delinquency subscale (e.g., cheated on tests, damaged school property, got suspended), the minor theft subscale, and the robbery subscale. For all scales, participants reported the number of times in the past two weeks they did a variety of actions; scales were then calculated as the sum of the occurrences. The minimum of each scale was 0 and there was no maximum, since there is no maximum amount participants could have done the actions listed.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
GAIN Substance Frequency Scale
The Global Appraisal of Individual Needs (GAIN) substance frequency scale assesses youth alcohol and substance use in the last two weeks. Alcohol days are number of days in the past two weeks that youth consumed alcohol. Drunk days are the number of days in the past two weeks that youth were drunk. Marijuana days are number of days in the past two weeks that youth used marijuana. As such, the minimum and maximum values are 0 and 14, respectively, and higher scores mean a worse outcome.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)
Assesses youth intrinsic motivation for prosocial behaviors. Contains four subscales: interest/enjoyment (minimum of 7, maximum of 49), perceived competence (minimum of 6, maximum of 42), value/usefulness (minimum of 7, maximum of 49), and effort/importance (minimum of 5, maximum of 35).
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Perceived Autonomy Support (PAS)
Assesses youth perceived autonomy-supportive and controlling parent behaviors. Contains four subscales: autonomy support, chaos, coercion, and structure. Each subscale has a youth version (minimum 4, maximum 16) and a parent version (minimum 5, maximum 20). Higher scores indicate better outcomes on the autonomy and structure scales and worse outcomes on the chaos and coercion scales.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Perceived Stress Scale (PSS)
Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Parent Locus of Control Scale
Assesses parent sense of control/efficacy and supervision of youth. One sub-scale for helplessness and one sub-scale for feeling out of control. Both subscales have a minimum of 10 and maximum of 50. Higher scores are a worse outcome.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Loeber Parenting Scale
Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. Subscales are Supervision (minimum of 10 and a maximum of 28 for both the parent and youth scales), Inconsistent Discipline (minimum of 9 and a maximum of 27 for the youth scale, minimum of 5 and maximum of 15 for the parent scales), Reward Use (minimum of 9 and maximum of 27 for both parent and youth scales), and Discipline Effectiveness (minimum of 3 and a maximum of 10 on the parents scale, no youth scale); higher scores mean higher prevalence, lower scores mean infrequency.
Measured: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201828 Feb 2020

First posted28 Feb 2017
Study start16 Jul 2018
Primary completion28 Feb 2020
Study completion28 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Child Behavior DisordersStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03065517
Sponsor's protocol ID: R44MH097349
Other IDs: R44MH097349
Acronym: VillageWhere
Status last verified: May 2022
First submitted: 16 Feb 2017
Last updated: 2 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.

Publications

Schaeffer CM, Dimeff LA, Koerner K, Chung J, Kelley-Brimer A, Kako N, Ilac M, Tuerk E, Carroll D, Beadnell B. A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):52-66. doi: 10.1080/15374416.2022.2070851. Epub 2022 May 31.
PubMed 35640058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Child Behavior Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Mobile Technology to Enhance MST Outcomes
ClinicalTrials.gov ID: NCT03065517
Acronym / sponsor ID: VillageWhere / R44MH097349
Conditions: Child Behavior Disorders
Keywords: Criminal Justice, Juvenile Delinquency
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: Evidence-Based Practice Institute, Seattle, WAIndustry (pharma, biotech, devices)
Collaborators: National Institute of Mental Health (NIMH), University of Maryland, Baltimore
Study start: 16 Jul 2018 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 28 Feb 2017 (actual)
Results: Posted 2 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VillageWhere App	Experimental	Device: VillageWhere AppParent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial. The app is designed to be used several times throughout each day.
Attention-Control Placebo App	Placebo comparator	Device: Attention-Control Placebo AppParent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial.

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

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
VillageWhere AppVillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.	Device	VillageWhere App
Attention-Control Placebo AppMobile phone app for use on both Android and iOS platforms.	Device	Attention-Control Placebo App

Primary outcome

Child Behavior Checklist (CBCL)
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 36) and aggressive behavior (minimum of 0, maximum of 34). Higher scores are a worse outcome.
Youth Self-Report (YSR)
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 34) and aggressive behavior (minimum of 0, maximum of 36). Higher scores indicate worse outcomes.
Self-Report of Delinquent Behavior Scale
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses youth delinquent behaviors. Contains one main scale: the general delinquency scale. There are also several subscales: the status offenses (e.g., ran away from home, purchased alcohol, truant) subscale, the school delinquency subscale (e.g., cheated on tests, damaged school property, got suspended), the minor theft subscale, and the robbery subscale. For all scales, participants reported the number of times in the past two weeks they did a variety of actions; scales were then calculated as the sum of the occurrences. The minimum of each scale was 0 and there was no maximum, since there is no maximum amount participants could have done the actions listed.
GAIN Substance Frequency Scale
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
The Global Appraisal of Individual Needs (GAIN) substance frequency scale assesses youth alcohol and substance use in the last two weeks. Alcohol days are number of days in the past two weeks that youth consumed alcohol. Drunk days are the number of days in the past two weeks that youth were drunk. Marijuana days are number of days in the past two weeks that youth used marijuana. As such, the minimum and maximum values are 0 and 14, respectively, and higher scores mean a worse outcome.
Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses youth intrinsic motivation for prosocial behaviors. Contains four subscales: interest/enjoyment (minimum of 7, maximum of 49), perceived competence (minimum of 6, maximum of 42), value/usefulness (minimum of 7, maximum of 49), and effort/importance (minimum of 5, maximum of 35).
Perceived Autonomy Support (PAS)
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses youth perceived autonomy-supportive and controlling parent behaviors. Contains four subscales: autonomy support, chaos, coercion, and structure. Each subscale has a youth version (minimum 4, maximum 16) and a parent version (minimum 5, maximum 20). Higher scores indicate better outcomes on the autonomy and structure scales and worse outcomes on the chaos and coercion scales.
Perceived Stress Scale (PSS)
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.
Parent Locus of Control Scale
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses parent sense of control/efficacy and supervision of youth. One sub-scale for helplessness and one sub-scale for feeling out of control. Both subscales have a minimum of 10 and maximum of 50. Higher scores are a worse outcome.
Loeber Parenting Scale
Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. Subscales are Supervision (minimum of 10 and a maximum of 28 for both the parent and youth scales), Inconsistent Discipline (minimum of 9 and a maximum of 27 for the youth scale, minimum of 5 and maximum of 15 for the parent scales), Reward Use (minimum of 9 and maximum of 27 for both parent and youth scales), and Discipline Effectiveness (minimum of 3 and a maximum of 10 on the parents scale, no youth scale); higher scores mean higher prevalence, lower scores mean infrequency.

Results and safety

Results posted to the registry on 2 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VillageWhere App	110	84
Attention-Control Placebo App	106	90

Primary outcome: Child Behavior Checklist (CBCL)

Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).. Mean (Standard Deviation). Unit: score on a scale

Measure	VillageWhere App n = 55	Attention-Control Placebo App n = 53
Rule-Breaking Time 1	10.73 (5.86)	11.45 (5.51)
Rule-Breaking Time 2	7.88 (5.50)	7.49 (5.19)
Rule-Breaking Time 3	6.98 (5.43)	7.31 (5.90)
Rule-Breaking Time 4	7.12 (5.95)	6.69 (6.29)
Aggressive Behavior Time 1	19.31 (8.22)	20.53 (7.80)
Aggressive Behavior Time 2	14.14 (6.43)	13.53 (7.84)
Aggressive Behavior Time 3	11.93 (7.40)	12.89 (7.50)
Aggressive Behavior Time 4	10.93 (8.23)	12.70 (8.48)

Population analysed: The number analyzed differs between rows because of attrition over different timepoints.

Primary outcome: Youth Self-Report (YSR)

Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).. Mean (Standard Deviation). Unit: score on a scale

Measure	VillageWhere App n = 55	Attention-Control Placebo App n = 52
Rule-Breaking Time 1	11.07 (5.66)	10.33 (4.87)
Rule-Breaking Time 2	9.41 (4.38)	8.40 (4.34)
Rule-Breaking Time 3	9.50 (5.41)	7.02 (3.38)
Rule-Breaking Time 4	9.70 (5.38)	7.07 (4.71)
Aggressive Behavior Time 1	16.22 (7.50)	15.25 (7.05)
Aggressive Behavior Time 2	13.88 (6.54)	11.86 (5.79)
Aggressive Behavior Time 3	12.08 (6.60)	9.67 (5.29)
Aggressive Behavior Time 4	11.93 (8.40)	10.51 (5.86)

Population analysed: The number analyzed differs between rows because of attrition over timepoints.

Primary outcome: Self-Report of Delinquent Behavior Scale

Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).. Mean (Standard Deviation). Unit: Occurrences

Measure	VillageWhere App n = 55	Attention-Control Placebo App n = 51
General Delinquency Time 1	16.91 (64.41)	7.96 (14.0)
General Delinquency Time 2	9.03 (15.80)	4.29 (10.14)
General Delinquency Time 3	3.74 (5.87)	3.98 (10.12)
General Delinquency Time 4	2.97 (4.73)	3.32 (5.52)
Status Offenses Time 1	3.04 (11.13)	2.24 (3.97)
Status Offenses Time 2	.9 (1.66)	.67 (1.28)
Status Offenses Time 3	0.74 (1.74)	1.04 (2.25)
Status Offenses Time 4	.73 (1.91)	1.15 (2.74)

Population analysed: Number analyzed differs between rows because of attrition over timepoints.

Primary outcome: GAIN Substance Frequency Scale

Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).. Mean (Standard Deviation). Unit: Days

Measure	VillageWhere App n = 55	Attention-Control Placebo App n = 52
Alcohol Days Time 1	.76 (2.227)	.48 (1.488)
Alcohol Days Time 2	.15 (.573)	.00 (.00)
Alcohol Days Time 3	.30 (.791)	.23 (.782)
Alcohol Days Time 4	.25 (.776)	.12 (.640)
Drunk Days Time 1	.51 (1.999)	.17 (.734)
Drunk Days Time 2	.00 (.00)	.00 (.00)
Drunk Days Time 3	.18 (.594)	.16 (.531)
Drunk Days Time 4	.05 (.316)	.34 (1.353)

Population analysed: Number analyzed differs between rows because of attrition over timepoints.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VillageWhere App	0 of 110 (0%)	0 of 110 (0%)	0 of 110
Attention-Control Placebo App	0 of 106 (0%)	0 of 106 (0%)	0 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35640058Schaeffer CM, Dimeff LA, Koerner K, Chung J, Kelley-Brimer A, Kako N, Ilac M, Tuerk E, Carroll D, Beadnell B. A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):52-66. doi: 10.1080/15374416.2022.2070851. Epub 2022 May 31.
Individual participant dataSharing planned: Yes. Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.

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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.

Linda Dimeff, PhD principal investigator

Evidence-Based Practice Institute

Cindy Schaeffer, PhD principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VillageWhere App in people with Child Behavior Disorders, run by Evidence-Based Practice Institute, Seattle, WA at 1 site 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?

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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Child Behavior Checklist (CBCL) (time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03065517, which also lists 1 linked publication.

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 2 Jun 2022.