Phone App for Grounding

December 12, 2021 updated by: Treatment Innovations

Phone App for Grounding (De-escalation) of Substance-abusing Transition-age Youth

The goal of this project is 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S. population. Transition-age youth (TAY) from ages 18-25 are especially vulnerable to substance use and SUD. This time period represents 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; and attaining legal drinking age. 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. This project focused 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 phase 1 the investigator 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. An iterative product development methodology was used based on end-user feedback and the impact of the app was studied 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 the investigator proposes to scale up both the app and the evaluation of it. There are 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. The primary outcome is based on power analysis from the phase 1 pilot; other outcomes and measures are also included. The RCT uses rigorous scientific methods in its design, measures, and statistics.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Treatment Innovations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatient
  • meets criteria for substance use disorder per the treatment site
  • has a smartphone (either Android or iOS)
  • has not attended and is not currently attending Seeking Safety treatment

Exclusion Criteria:

  • current uncontrolled psychotic or bipolar disorder
  • currently criminal-justice involved such that we would need to report substance use or other possible criminal behavior (e.g., to a parole or probation officer)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Grounding enhanced app
A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
Behavioral: Grounding enhanced app
A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
Active Comparator: Grounding text-only app
A mobile app that uses the Seeking Safety grounding chapter content in text format only
Behavioral: Grounding text-only app
A mobile app that uses the Seeking Safety grounding chapter content in text format only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Grounding Knowledge Test
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total time spent on the app
Time Frame: 6 weeks
6 weeks
BASIS-32 Impulsive and Addictive Behavior subscale
Time Frame: 6 weeks
6 weeks
Difficulties in Emotion Regulation Scale
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Brief Addiction Monitor
Time Frame: 6 weeks
6 weeks
Coping Self-Efficacy Scale
Time Frame: 6 weeks
6 weeks
BASIS-32 total score
Time Frame: 6 weeks
6 weeks
Perceived Stress Scale
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Treatment Innovations

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Najavits, PhD, Treatment Innovations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R44AA026746-02A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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