Child Behavior DisordersVillageWhereNCT02320903
Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes
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.
Trial summary
The goal of the current trial is to assess the feasibility of a newly developed prototype of a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes of youth with externalizing behavioral problems by improving parental monitoring of youth whereabouts and activities while increasing… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Disorders
- What is being tested?
- VillageWhere App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2016
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Teen: English speaking, between ages of 13 and 17, juvenile justice involvement and/or externalizing behavioral problems, currently in treatment and will remain in treatment for duration of trial
- Caregiver: English speaking, owns Android smart phone, currently in treatment with their teen and will remain in treatment for duration of trial
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Evidence-Based Practice Institute
Seattle, Washington, 98144
About this study
Official title: Phase I - Using Mobile Technology to Enhance MST Outcomes (VillageWhere)
The goal of the current trial is to assess the feasibility of a newly developed prototype of a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes of youth with externalizing behavioral problems by improving parental monitoring of youth whereabouts and activities while increasing the delivery of rewards to teens for good behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop and conduct initial feasibility testing of the VillageWhere prototype. The primary features of the prototype include location monitoring via smartphones' global positioning system (GPS) functionality as well as facilitating teen self-appraisal of meeting behavioral expectations. Good behavior is rewarded with points that are tracked by the app and can be used to redeem for real-world rewards. The investigators will conduct an 45-day open trial (N=20 caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved in the juvenile justice system or otherwise struggling with externalizing behavioral problems. Caregivers and teens will be assessed at baseline, before receiving the app, and at the end of the app use period (45 days). The therapist of each caregiver/teen dyad will also be assessed at the end of the app use period. Primary outcomes include: use of app features, monitoring of teen behavior and whereabouts, delivery of real-world rewards, and feasibility and acceptability. Secondary outcomes include: parenting behaviors, externalizing teen behaviors and internalizing teen behaviors.
Read the detailed description
VillageWhere was pilot tested with a sample of 16 youth and their primary caregiver participating in an EST for a serious conduct problem (Mean age 14.6 years, 52% male, 56% African American, 33% were previously arrested). After completing baseline self-report measures, dyads used the app as desired for 4 weeks, then participated in a post-assessment and qualitative interviews. App usage by both parents and youth was high with little diminished use over the four weeks of the trial. All parents set and used reinforcers for functional behavior and used the "find my teen" feature; 84% set geolocation expectations for youth's whereabouts at specific times; and 88% set other expectations for the youth (e.g., finish homework), viewed notifications, and regularly used the "Find My Teen" feature. As expected, parents interacted with the app frequently: 2.4 times per day. Youth used the app on average four times per day. All youth earned and redeemed points for complying with their parent's expectations and routinely viewed their behavior plans (93.3%) and feedback notification messages (86.7%). Parents did not on average use coaching videos (20%).
Although the study was not powered to detect statistical significance, a series of paired t-tests were conducted to examine pre- to post-changes on self-report measures. Changes for parents and youth all were in predicted directions, with effect sizes ranging from small to high (average d = .42, range .21-.80). Parents reported greater use of positive parenting behaviors (i.e., rewards and praise), greater discipline consistency, lower overall perceived stress, a higher feeling of influence over youth behavior, and greater parenting efficacy. Youth reported increases in parent use of positive behaviors, consistency, and knowledge of whereabouts. Parent- and youth-reported change in youth aggression and rule-breaking (as measured by the CBCL/YSR).
Qualitative results were also positive. Using 7-point scales, parents and youth reported on app satisfaction three times/week. Parent ratings were high (M = 6.0) across items (e.g., "The app was helpful today," "I have ways to intervene with my teen"). Youth satisfaction scores were also high (M = 6.1; e.g., "My parent is noticing \& rewarding my good behavior;" "I liked getting app prompts \& reminders"). Parents reported that the app helped them trust their youth, increase their use of rewards, and made giving rewards easier; they also reported a reduction in youths' "excuse-making." Youth perceived that the app allowed them more freedom, because parents had an objective way of verifying their whereabouts. Nearly all youth (89%) liked that their parent was more consistent in paying attention to their positive behaviors and rewarding them for it (versus only being punitive). Both parents and youth described significant improvements in their relationship.
In addition, 16 therapists working with the parent-youth dyads also gave qualitative feedback that was highly positive. Therapists stated that they liked the extra accountability the app afforded to teens and the reduction in parent-youth communication issues.
- Conditions
- Child Behavior Disorders
- Being tested
- VillageWhere 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
| Study group | Role | What they receive |
|---|---|---|
| Use of VillageWhere App Prototype | Experimental | In this single-arm study design, all enrolled caregivers and teens will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day. Receives: Device: VillageWhere App |
What is being measured
The primary outcome is the main question the study is designed to answer.
App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen
Percent of parents who set up a behavior plan for teen using app features.
Measured: up to 45-days
App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior
How many parents/caregivers set up a reward system and redeemed at least some points for the teen.
Measured: up to 45-days
App Usage - Parent Set Geolocation Expectations for the Teen.
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
Measured: up to 45-days
App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met
The percentage of participants who viewed notifications that the teen was or was not meeting a behavioral expectation. Both parents and teens had this capability.
Measured: up to 45 days
App Usage - Viewed Parent Coaching Videos
The app included 5 brief video vignettes depicting an effective parenting technique.
Measured: up to 45 days
App Usage - View Progress Graph (Points Earned Over Time)
Youth/teen points earned over time were depicted on a graph for each day of use. To view the graph, caregivers/parents and youth/teens had to click on an app button.
Measured: up to 45 days
App Satisfaction Rating - the App Was Helpful Today
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), how helpful was the app to you today?
Measured: up to 45 days
App Satisfaction Rating - I Have Ways to Intervene With my Teen.
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), the app gives me new ways of intervening with my teen.
Measured: up to 45 days
App Satisfaction Rating - Overall Satisfaction
Parent/caregiver and teen was prompted randomly 3 times each week to rate on a scale of 1 (totally unsatisfied) to 7 (completely satisfied), overall, how satisfied are you with the app today?
Measured: up to 45 days
App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior
Three times each week, at random, youth/teens were asked to rate on a scale of 1 (strongly disagree) to 7 (strongly agree), my parent is noticing and rewarding good behavior. All ratings were averaged across full period of app use.
Measured: up to 45 days
App Satisfaction - I Like Getting Prompts and Reminders
Youth/teens in the study were prompted 3 times/week during period of app usage to rate, on a scale of 1 (strongly disagree) to 7 (strongly agree), "I like getting prompts and reminders from the app."
Measured: up to 45 days
Secondary outcomes (10)
Achenbach System of Empirically-Based Assessment, Aggression Subscale
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the aggression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 36; a score of 13 or higher indicates clinically significant aggression, defined as aggression that is higher than that of 93% of teens in the United States.
Measured: Baseline and Post assessment (end of 45-day app use period)
Achenbach System of Empirically-Based Assessment, Depression Subscale
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the depression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 26; a score of 8 or higher indicates clinically significant depression, defined as depressive symptoms higher than that of 93% of teens in the United States.
Measured: Baseline and Post assessment (end of 45-day app use period)
Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the rule-breaking subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 34; a score of 9 or higher indicates clinically significant rule-breaking, defined as rule-breaking that is higher than that of 93% of teens in the United States.
Measured: Baseline and Post assessment (end of 45-day app use period)
Loeber Parental Supervision Scale
This measure of extent to which parents supervise and monitor youth whereabouts was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 8-item scale has a scored range of 0 (minimum score) - 16 (maximum score), with high scores indicating more or better parental supervision/monitoring.
Measured: Baseline and Post assessment (end of 45-day app use period)
Loeber Positive Parenting Scale
This measure of extent to which parents express warmth and encouragement to youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 9-item scale has a scored range of 0 (minimum score) - 18 (maximum score), with high scores indicating more parental positivity.
Measured: Baseline and Post assessment (end of 45-day app use period)
Loeber Parental Consistency Scale
This measure of extent to which parents are consistent in their rules, expectations, and discipline techniques with youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage. This 5-item scale has a scored range of 0 (minimum score) - 10 (maximum score), with high scores indicating more consistent / better parental discipline follow-through.
Measured: Baseline and Post assessment (end of 45-day app use period)
Loeber Parental Effectiveness Scale
Degree to which parents feel that their parenting techniques are working in terms of managing teen behavior challenges. This 3-item scale has a scored range of 0 (minimum score) - 8 (maximum score), with high scores indicating better discipline effectiveness (e.g., "I feel like the punishment I give works in curbing youth behavior").
Measured: Change over 30 days of app usage (baseline to post-assessment)
Perceived Stress Scale (PSS)
Degree to which parents are experiencing stress related to parenting. This 10-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating more stress related to parenting.
Measured: Change over 30 days of app usage (baseline to post-assessment)
Parental Locus of Control Scale
Degree to which parents feel efficacious and confident in managing parenting challenges. This 20-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating that the parent has a higher sense of feeling efficacious in their role as a parent.
Measured: Change over 30 days of app usage (baseline to post-assessment)
Loeber Parental Knowledge Scale
Youth report of how much parents actually know about the youth's whereabouts/activities. This 5-item scale has a scored range of 0 (minimum score) - 15 (maximum score), with high scores indicating that the parent knows more about what teens are actually doing.
Measured: over 30 days of app usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidence-Based Practice Institute, Seattle, WA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Linda A. Dimeff, PhD, Principal investigator, Evidence-Based Practice InstituteCindy M Schaeffer, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320903
- Sponsor's protocol ID
- 1R43MH097349-01
- Other IDs
- 1R43MH097349-01
- Acronym
- VillageWhere
- Status last verified
- Nov 2017
- First submitted
- 16 Dec 2014
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I - Using Mobile Technology to Enhance MST Outcomes (VillageWhere)
- ClinicalTrials.gov ID
- NCT02320903
- Acronym / sponsor ID
- VillageWhere / 1R43MH097349-01
- Conditions
- Child Behavior Disorders
- Keywords
- Criminal Justice, Juvenile Delinquency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Evidence-Based Practice Institute, Seattle, WAIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Medical University of South Carolina
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the current trial is to assess the feasibility of a newly developed prototype of a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes of youth with externalizing behavioral problems by improving parental monitoring of youth whereabouts and activities while increasing the delivery of rewards to teens for good behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop and conduct initial feasibility testing of the VillageWhere prototype. The primary features of the prototype include location monitoring via smartphones' global positioning system (GPS) functionality as well as facilitating teen self-appraisal of meeting behavioral expectations. Good behavior is rewarded with points that are tracked by the app and can be used to redeem for real-world rewards. The investigators will conduct an 45-day open trial (N=20 caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved in the juvenile justice system or otherwise struggling with externalizing behavioral problems. Caregivers and teens will be assessed at baseline, before receiving the app, and at the end of the app use period (45 days). The therapist of each caregiver/teen dyad will also be assessed at the end of the app use period. Primary outcomes include: use of app features, monitoring of teen behavior and whereabouts, delivery of real-world rewards, and feasibility and acceptability. Secondary outcomes include: parenting behaviors, externalizing teen behaviors and internalizing teen behaviors.
Detailed description
VillageWhere was pilot tested with a sample of 16 youth and their primary caregiver participating in an EST for a serious conduct problem (Mean age 14.6 years, 52% male, 56% African American, 33% were previously arrested). After completing baseline self-report measures, dyads used the app as desired for 4 weeks, then participated in a post-assessment and qualitative interviews. App usage by both parents and youth was high with little diminished use over the four weeks of the trial. All parents set and used reinforcers for functional behavior and used the "find my teen" feature; 84% set geolocation expectations for youth's whereabouts at specific times; and 88% set other expectations for the youth (e.g., finish homework), viewed notifications, and regularly used the "Find My Teen" feature. As expected, parents interacted with the app frequently: 2.4 times per day. Youth used the app on average four times per day. All youth earned and redeemed points for complying with their parent's expectations and routinely viewed their behavior plans (93.3%) and feedback notification messages (86.7%). Parents did not on average use coaching videos (20%).
Although the study was not powered to detect statistical significance, a series of paired t-tests were conducted to examine pre- to post-changes on self-report measures. Changes for parents and youth all were in predicted directions, with effect sizes ranging from small to high (average d = .42, range .21-.80). Parents reported greater use of positive parenting behaviors (i.e., rewards and praise), greater discipline consistency, lower overall perceived stress, a higher feeling of influence over youth behavior, and greater parenting efficacy. Youth reported increases in parent use of positive behaviors, consistency, and knowledge of whereabouts. Parent- and youth-reported change in youth aggression and rule-breaking (as measured by the CBCL/YSR).
Qualitative results were also positive. Using 7-point scales, parents and youth reported on app satisfaction three times/week. Parent ratings were high (M = 6.0) across items (e.g., "The app was helpful today," "I have ways to intervene with my teen"). Youth satisfaction scores were also high (M = 6.1; e.g., "My parent is noticing \& rewarding my good behavior;" "I liked getting app prompts \& reminders"). Parents reported that the app helped them trust their youth, increase their use of rewards, and made giving rewards easier; they also reported a reduction in youths' "excuse-making." Youth perceived that the app allowed them more freedom, because parents had an objective way of verifying their whereabouts. Nearly all youth (89%) liked that their parent was more consistent in paying attention to their positive behaviors and rewarding them for it (versus only being punitive). Both parents and youth described significant improvements in their relationship.
In addition, 16 therapists working with the parent-youth dyads also gave qualitative feedback that was highly positive. Therapists stated that they liked the extra accountability the app afforded to teens and the reduction in parent-youth communication issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of VillageWhere App Prototype | Experimental | Device: VillageWhere AppIn this single-arm study design, all enrolled caregivers and teens will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Teen: English speaking, between ages of 13 and 17, juvenile justice involvement and/or externalizing behavioral problems, currently in treatment and will remain in treatment for duration of trial
- Caregiver: English speaking, owns Android smart phone, currently in treatment with their teen and will remain in treatment for duration of trial
Key exclusion criteria (1 listed)
- N/A
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 App | Device | Use of VillageWhere App Prototype |
Primary outcome
App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen
Time frame: up to 45-days
Percent of parents who set up a behavior plan for teen using app features.
App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior
Time frame: up to 45-days
How many parents/caregivers set up a reward system and redeemed at least some points for the teen.
App Usage - Parent Set Geolocation Expectations for the Teen.
Time frame: up to 45-days
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met
Time frame: up to 45 days
The percentage of participants who viewed notifications that the teen was or was not meeting a behavioral expectation. Both parents and teens had this capability.
App Usage - Viewed Parent Coaching Videos
Time frame: up to 45 days
The app included 5 brief video vignettes depicting an effective parenting technique.
App Usage - View Progress Graph (Points Earned Over Time)
Time frame: up to 45 days
Youth/teen points earned over time were depicted on a graph for each day of use. To view the graph, caregivers/parents and youth/teens had to click on an app button.
App Satisfaction Rating - the App Was Helpful Today
Time frame: up to 45 days
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), how helpful was the app to you today?
App Satisfaction Rating - I Have Ways to Intervene With my Teen.
Time frame: up to 45 days
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), the app gives me new ways of intervening with my teen.
App Satisfaction Rating - Overall Satisfaction
Time frame: up to 45 days
Parent/caregiver and teen was prompted randomly 3 times each week to rate on a scale of 1 (totally unsatisfied) to 7 (completely satisfied), overall, how satisfied are you with the app today?
App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior
Time frame: up to 45 days
Three times each week, at random, youth/teens were asked to rate on a scale of 1 (strongly disagree) to 7 (strongly agree), my parent is noticing and rewarding good behavior. All ratings were averaged across full period of app use.
App Satisfaction - I Like Getting Prompts and Reminders
Time frame: up to 45 days
Youth/teens in the study were prompted 3 times/week during period of app usage to rate, on a scale of 1 (strongly disagree) to 7 (strongly agree), "I like getting prompts and reminders from the app."
10 secondary outcomes
Achenbach System of Empirically-Based Assessment, Aggression Subscale
Time frame: Baseline and Post assessment (end of 45-day app use period)
Achenbach System of Empirically-Based Assessment, Depression Subscale
Time frame: Baseline and Post assessment (end of 45-day app use period)
Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale
Time frame: Baseline and Post assessment (end of 45-day app use period)
Loeber Parental Supervision Scale
Time frame: Baseline and Post assessment (end of 45-day app use period)
Loeber Positive Parenting Scale
Time frame: Baseline and Post assessment (end of 45-day app use period)
Loeber Parental Consistency Scale
Time frame: Baseline and Post assessment (end of 45-day app use period)
Loeber Parental Effectiveness Scale
Time frame: Change over 30 days of app usage (baseline to post-assessment)
Perceived Stress Scale (PSS)
Time frame: Change over 30 days of app usage (baseline to post-assessment)
Parental Locus of Control Scale
Time frame: Change over 30 days of app usage (baseline to post-assessment)
Loeber Parental Knowledge Scale
Time frame: over 30 days of app usage
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 A. Dimeff, PhD principal investigator
Evidence-Based Practice Institute
Cindy M 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?
The sponsor lists 2 inclusion and 1 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 14 Feb 2018. 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. 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 14 Feb 2018). 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?
App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen (time frame: up to 45-days). The study lists 11 primary outcomes in all. 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 14 Feb 2018.