SBIR-STTR Award

Phone App for Grounding (De-Escalation) of Substance-Abusing Transition-Age Youth
Award last edited on: 6/6/2019

Sponsored Program
SBIR
Awarding Agency
NIH : NIAAA
Total Award Amount
$1,596,528
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Lisa M Najavits

Company Information

Treatment Innovations LLC (AKA: Seeking Safety)

28 Westbourne Road
Newton Centre, MA 02459
   (617) 299-1670
   info@seekingsafety.org
   www.seekingsafety.org
Location: Single
Congr. District: 04
County: Middlesex

Phase I

Contract Number: 1R43DA038393-01
Start Date: 8/1/2014    Completed: 7/31/2015
Phase I year
2014
Phase I Amount
$224,999
Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S. population, with 14.6% developing it in their lifetime. Transition-age youth (TAY) from ages 18-24 are especially vulnerable to substance use, misuse, and SUD. This developmental period, termed the 'age of instability' includes tasks such as leaving home; entering college; working for the first time; body and sexuality changes; coalescing with a peer group; and for some, aging out of foster care or state custody, which end at age 18. This period is also prime for experimentation with substance use and associated risks such as driving under the influence, accidents, fighting and violence, HIV, and vulnerability to sexual assault. In this project, we focus on a major strategy, grounding, for helping to de-escalate (reduce) intense negative emotions and impulses. Grounding has long been used in psychiatric hospitals to provide a safe, quick, and powerful way to reduce any intense negative feeling, including impulses to hurt self or others, substance craving, anger, anxiety, etc. Described in detail in the book 'Seeking Safety' (SS), grounding uses three pathways to focus the mind (mental), the body (physical), and the heart (soothing). Grounding provides a way to regulate emotion, which is a major challenge for youth, especially given their hormone changes and emotional intensity. Indeed, substance use is often described as a short-term way to regulate emotion. Grounding is a key module of SS, a widely-implemented, evidence-based SUD treatment model. In this proposal we focus exclusively on grounding as it is an essential skill and widely identified as easy to learn across even the most complex and vulnerable clients. We propose to turn grounding into a smartphone app because grounding should be used in the environment in which the distress is experienced; it capitalizes on TAY use of smartphones; promotes self-regulation; and is a stand- alone skill and sensory-oriented, thus ideal for a mobileapp approach. Our specific aims are: (1) to develop a new product, a smartphone Grounding App. This will be an exciting, interactive Android app that uses state-of- the-art gaming technology to engage TAY in grounding, in collaboration with an outstanding company for the technology side of the project. (2) To use an iterative product development methodology based on end-user feedback. We propose various methods to obtain initial input from TAY with SUD before beginning app programming. (3) To conduct a small feasibility study of the app. This cross-sectional pilot will obtain information on end-users experience, usage, and satisfaction with the app, which can inform a phase II study. We will assign 24 TAY with SUD to the grounding app (n=12) versus receiving hard-copy grounding handouts from the SS book (n=12), to evaluate the relative impact of the app. Our team represents an exceptional mix of expertise in SUD, TAY, app and gaming technology innovation, grounding, SBIRs, treatment development, and public-health oriented products based on evidence-based care.

Thesaurus Terms:
Accidents;Age;Aging;Alcohol Or Other Drugs Use;Anger;Anxiety;Base;Biometry;Books;Caring;Client;Clinical Trials;Cognitive;Coin;Collaborations;College;Complex;County;Craving;Depressed Mood;Design;Development;Distress;Driving Under Influence;Educational Process Of Instructing;Emerging Adulthood;Emotion Regulation;Emotional;Emotions;Environment;Evidence Base;Experience;Family;Feasibility Studies;Feedback;Feeling;Fighting;Focus Groups;Forcible Intercourse;Foster Care;Glosso-Sterandryl;Goals;Healthcare;Heart;Heart Rate;Hiv;Home Environment;Hormones;Housing;Impairment;Individual;Informal Social Control;Innovation;Language;Learning;Left;Manuals;Marble;Mental Depression;Mental Health;Methodology;Methods;Mind;Mindfulness;Mobile Application;Modeling;Nature;Panic;Paper;Pathway Interactions;Peer Group;Phase;Phase 2 Study;Population;Process;Product Development;Programs;Proxy;Psyche Structure;Psychiatric Diagnosis;Psychiatric Hospitals;Public Health Medicine (Field);Public Health Relevance;Q-Sort;Rage;Reading;Recruitment Activity;Relative (Related Person);Relaxation;Risk;Safety;Satisfaction;Sensor;Sensory;Sexual Assault;Sexuality;Side;Skills;Small Business Innovation Research Grant;Spottings;Staging;Stress;Substance Abuse Problem;Substance Abuse Treatment;Substance Use Disorder;Technology;Telephone;Therapy Development;Time;Training;Translating;Treatment Program;User-Friendly;Violence;Viral;Web Site;Work;Youth;

Phase II

Contract Number: 9R44AA026746-02A1
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2017
(last award dollars: 2018)
Phase II Amount
$1,371,529

Abstract Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S. population, with 14.6% developing it in their lifetime. Transition-age youth (TAY) from ages 18-25 are especially vulnerable to substance use and SUD. This time period, termed the “age of instability", is now understood to represent a distinct stage separate from adolescence and later adulthood. It includes tasks such as leaving home to enter college, the workforce, or the military; clarifying vocational goals; attaining legal drinking age; and, for some, aging out of foster care or state custody, which end at age 18. This period is also prime for experimentation with substance use and associated risks such as driving under the influence, accidents, fighting and violence, HIV, and vulnerability to sexual assault. In this project, we focus on a major strategy, grounding, to help TAY de-escalate (reduce) intense negative emotions and impulses. Grounding has long been used in psychiatric hospitals to provide a safe, quick, and powerful way to reduce any intense negative feeling such as impulses to hurt self or others, substance craving, anger, anxiety, etc. Described in detail in the book Seeking Safety (SS), grounding using three pathways to focus the mind (mental), body (physical), and heart (soothing). Grounding provides a way to regulate emotion, which is a major challenge for TAY, especially given their hormone changes and emotional intensity. Indeed substance use is often described as a short-term way to regulate emotion. Grounding is a key module of SS, a widely-implemented, evidence-based SUD treatment model. In this proposal we focus exclusively on grounding as it is an essential skill and widely identified as easy to learn for even the most complex and vulnerable clients. In phase 1 we developed a beta version of a grounding app. The app promotes the use of grounding in any environment in which emotions and impulses need to be regulated. It capitalizes on TAYs’ widespread use of mobile devices; and because grounding is a stand-alone skill and sensory-oriented, it lends itself wonderfully to an app approach. We used an iterative product development methodology based on end-user feedback and studied the impact of the app in a pilot randomized controlled trial (RCT) with 24 TAY. Half received the app and the other half received grounding handouts. Results showed that the app was consistently more positively rated than the handouts and was associated with significantly more use of grounding and a higher score on a grounding knowledge test. All phase 1 benchmarks were met. In phase 2 we propose to scale up both the app and the evaluation of it. We have two specific aims: (1) To enhance the mobile grounding app by using exciting, innovative technology approaches as well as expanding the grounding content in amount and type. (2) To conduct an RCT with 68 TAY to evaluate the grounding app versus a control app. The control app would control for both the use of a mobile device and the grounding content. However it would lack the gamification and technology innovations of the experimental app so that we can determine the impact of these. Our primary outcome is based on power analysis from our phase 1 pilot; we also include other outcomes and measures. The RCT uses rigorous scientific methods in its design, measures, and statistics. Our team represents an exceptional mix of expertise in SUD, TAY, app and gaming technology, grounding, SBIRs, and public health oriented products based on evidence-based care.

Public Health Relevance Statement:
Narrative We propose to continue to develop a smartphone application ("app") to help youth from ages 18-25 who have a substance abuse problem. The app will engage them in grounding, which is a sensory-based experience to help them feel calm by reducing intense negative feelings and impulses (such as the urge to use a substance or hurt themselves or others).

Project Terms:
Accidents; Addictive Behavior; Adolescence; Adult; Age; Aging; Alcohol or Other Drugs use; Anger; Anxiety; base; Benchmarking; Books; Caring; Cellular Phone; Client; Clinical; Clinical Research; college; Complex; Consult; craving; design; Development; Distress; driving under influence; emerging adulthood; emotion regulation; Emotional; Emotions; Environment; Evaluation; evidence base; experience; Family; Feedback; Feeling; fighting; foster care; Goals; handheld mobile device; Heart; Heart Rate; high risk; HIV; Home environment; Hormones; Impaired cognition; Impulsivity; Individual; innovation; innovative technologies; Knowledge; Learning; legal drinking age; Location; Manuals; Measures; Mental disorders; Mental Health; Methodology; Methods; Military Personnel; Mind; mobile application; Modeling; novel; Outcome Measure; Pathway interactions; Phase; Phonation; Physiological; Population; power analysis; primary outcome; product development; programs; Proxy; Psyche structure; Psychiatric Diagnosis; Psychiatric Hospitals; Public Health; Randomized Controlled Trials; Risk; Safety; scale up; secondary outcome; Sensory; Series; sexual assault; skills; Social Network; statistics; Stress; Substance abuse problem; Substance Use Disorder; Technology; Telephone; Testing; Time; Violence; Walking; Work; Youth