跳至主要内容
临床试验/NCT02320903
NCT02320903已完成不适用

Phase I - Using Mobile Technology to Enhance MST Outcomes (VillageWhere)

Evidence-Based Practice Institute, Seattle, WA2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
2
主要终点
App Satisfaction Rating - the App Was Helpful Today

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: VillageWhere App (Device)

结局指标

主要结局

App Satisfaction Rating - the App Was Helpful Today

时间窗: 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 - I Like Getting Prompts and Reminders

时间窗: 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."

App Satisfaction Rating - I Have Ways to Intervene With my Teen.

时间窗: 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 Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen

时间窗: up to 45-days

Percent of parents who set up a behavior plan for teen using app features.

App Usage - Parent Set Geolocation Expectations for the Teen.

时间窗: 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

时间窗: 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 Satisfaction Rating - Overall Satisfaction

时间窗: 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

时间窗: 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 Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior

时间窗: up to 45-days

How many parents/caregivers set up a reward system and redeemed at least some points for the teen.

App Usage - Viewed Parent Coaching Videos

时间窗: 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)

时间窗: 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.

次要结局

  • Achenbach System of Empirically-Based Assessment, Aggression Subscale(Baseline and Post assessment (end of 45-day app use period))
  • Achenbach System of Empirically-Based Assessment, Depression Subscale(Baseline and Post assessment (end of 45-day app use period))
  • Loeber Positive Parenting Scale(Baseline and Post assessment (end of 45-day app use period))
  • Loeber Parental Knowledge Scale(over 30 days of app usage)
  • Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale(Baseline and Post assessment (end of 45-day app use period))
  • Parental Locus of Control Scale(Change over 30 days of app usage (baseline to post-assessment))
  • Loeber Parental Supervision Scale(Baseline and Post assessment (end of 45-day app use period))
  • Loeber Parental Consistency Scale(Baseline and Post assessment (end of 45-day app use period))
  • Loeber Parental Effectiveness Scale(Change over 30 days of app usage (baseline to post-assessment))
  • Perceived Stress Scale (PSS)(Change over 30 days of app usage (baseline to post-assessment))

研究者

发起方
Evidence-Based Practice Institute, Seattle, WA
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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