NCT03258905

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

August 16, 2017

Last Update Submit

December 12, 2021

Conditions

Substance-Related Disorders

Keywords

transition-age youthmobile appgroundingSeeking Safety

Outcome Measures

Primary Outcomes (1)

  • Grounding Knowledge Test

    6 weeks

Secondary Outcomes (3)

  • Total time spent on the app

    6 weeks

  • BASIS-32 Impulsive and Addictive Behavior subscale

    6 weeks

  • Difficulties in Emotion Regulation Scale

    6 weeks

Other Outcomes (4)

  • Brief Addiction Monitor

    6 weeks

  • Coping Self-Efficacy Scale

    6 weeks

  • BASIS-32 total score

    6 weeks

  • +1 more other outcomes

Study Arms (2)

Grounding enhanced app

EXPERIMENTAL

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

Grounding text-only app

ACTIVE COMPARATOR

A mobile app that uses the Seeking Safety grounding chapter content in text format only

Behavioral: Grounding text-only app

Interventions

Grounding enhanced appBEHAVIORAL

A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity

Grounding enhanced app
Grounding text-only appBEHAVIORAL

A mobile app that uses the Seeking Safety grounding chapter content in text format only

Grounding text-only app

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Innovations

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Lisa Najavits, PhD

    Treatment Innovations

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 23, 2017

Study Start

November 1, 2019

Primary Completion

September 3, 2020

Study Completion

September 3, 2020

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)