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Brief Intervention for Suicide Risk Reduction in High Risk Adolescents (ASAP)

Primary Purpose

Adolescent Behavior

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
As Safe As Possible
Brite
Treatment as Usual
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Behavior focused on measuring adolescence, suicidality, depression

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child participants will be adolescents (aged 12-17.11 years) admitted to an inpatient unit for a recent suicide attempt or significant suicidal ideation with a plan or intent. We define a suicide attempt, as per the Columbia Clinical Algorithm for Suicide Assessment (C-CASA), as "self-destructive behavior with inferred or stated intent to die."
  • Participants must be English-speaking.
  • Participants can have unipolar or bipolar disorder, conduct or oppositional disorder, eating disorder, or alcohol or substance use or abuse or dependence.

Exclusion Criteria:

  • Child participants to be excluded will be those with current psychosis, mania, <90% of ideal body weight, or IQ<70 (based on the age-appropriate Wechsler Intelligence Scale if concerns about intellectual capabilities are evident at assessment), as these conditions may require more intensive interventions or limit comprehension of the intervention components.

Sites / Locations

  • University of Pittsburgh
  • University of Texas Southwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASAP Treatment and Brite

Treatment as Usual

Arm Description

Participants in the experimental arm received the ASAP treatment, during their transition from inpatient to outpatient care, as well as the Brite app for distress tolerance/emotion regulation and safety planning.

Participants in this grouping were studied as they proceed from inpatient to outpatient care, per usual treatment protocols at each site. Participants completed paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.

Outcomes

Primary Outcome Measures

Suicidal behavior and ideation
Suicidal attempts were the major outcome and secondarily, suicidal ideation. Information about past and current suicidal behavior was obtained using the Columbia Suicide History Form, with ideation and behavior classified using the Columbia Suicide Severity Rating Scale (CSSRS). Self-reported ideation was assessed using the Suicidal Ideation Questionnaire - Junior (SIQ-Jr). The two main outcomes, assessing recurrent suicidal behavior and change in suicidal ideation, was assessed at weeks 4, 12, and 24.

Secondary Outcome Measures

Course of disorder and AC treatment.
Attendance to treatment and type of treatment was documented by the Treatment History Form. The electronic medical record and Youth Self Report will also be used to document the presence of psychiatric disorders. The Treatment History Form derives forms of treatment demonstrated on the Child and Adolescent Services Assessment (CASA) using the structure of the Adolescent Longitudinal Interval Follow-up (A-LIFE).
Treatment target: motivation for treatment
Participants rated readiness on a 1-10 scale to assess Readiness to change, Importance of change, and Confidence in ability To Change with regard to coping with suicidal urges [RICTC].
Treatment target: positive and negative affect
Positive and negative affect was monitored by the Positive and Negative Affect Scale [PANAS]).
Treatment target: emotion regulation
Emotion regulation was measured by the Regulation of Emotions Questionnaire.
Treatment target: distress tolerance
Distress tolerance was measured by the Distress Tolerance Scale.
Treatment target: social support
Perceived social support was assessed using the Multidimensional Scale of Perceived Social Support (MSPSS).
Client Satisfaction
Client Satisfaction about ASAP was obtained from the patient and a caretaking parent using the Client Satisfaction Questionnaire-8 (CSQ-8), which has been used in other adolescent treatment studies and has high internal consistency (coefficient α = .93). We also adapted the Computer System Usability Scale (CSUQ) to assess satisfaction with the phone app. The CSUQ was completed by the participant, and is based on earlier measures designed to predict the adoption of technology, based on two main factors: ease of use (easy to learn, access, flexibility, quality of sound, quality of visual display) and usefulness (able to access when needed, helpful when used), scored along 7-point Likert Scales.
Qualitative Interviews
With Dr. Lee's guidance, we conducted brief semi-structured exit interviews following the intervention with both the parent and teen, which were developed and coded on the basis of our original qualitative interviews, to assess the acceptability of treatment. In these interviews, we obtained feedback about perceived effectiveness of the components of treatment, the appropriateness of treatment targets, identification of other targets or approaches that would have been more helpful, barriers to participation, and utility of the phone apps. The phone app was designed to track how often the participant used the apps and what components were accessed. We obtained similar feedback from the ASAP clinicians and from the outpatient aftercare therapists. Based on exit interviews, participant satisfaction, and outcome data from the open trial, we modified the manual and app.

Full Information

First Posted
October 20, 2014
Last Updated
December 18, 2018
Sponsor
University of Pittsburgh
Collaborators
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02272179
Brief Title
Brief Intervention for Suicide Risk Reduction in High Risk Adolescents
Acronym
ASAP
Official Title
Brief Intervention for Suicide Risk Reduction in High Risk Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adolescent suicide is the 2nd leading cause of death in this age group. There are no validated treatments to decrease the risk of adolescent suicidal behavior, and there are especially no interventions to target the highest risk period for adolescent suicide and suicidal behavior, namely during the time of transition from inpatient to outpatient care. This purpose of this project was to develop a novel, brief intervention that can be delivered on an inpatient unit prior to the transition to outpatient care, and augment known factors to protect adolescents from suicidal behavior, and extend the impact of treatment by liaison with the outpatient therapist and the development of a personalized safety plan phone application. This treatment, ASAP, focuses on augmenting adherence to the components of ASAP and outpatient aftercare, development of a personalized Safety Plan, and Affect Protection, through helping the teen and family promote a positive mood, tolerate distress, engage in healthy emotion regulation and access social support.
Detailed Description
This 2-site R34 project developed a brief, flexible, manualized intervention with supporting phone app with the purpose of reducing the risk of suicidal behavior in adolescents with high suicidal ideation or a recent suicide attempt, during the transition from inpatient to outpatient care. This transition period is the highest risk period for attempted and completed suicide. Suicide is the 2nd leading cause of adolescent mortality, and there are currently no established interventions for suicidal teens. By developing a treatment that can be delivered on an inpatient unit prior to the transition to outpatient treatment, we anticipated being able to lower suicidal risk and increase the likelihood that participants will attend subsequent outpatient treatment. In keeping with the priorities of NIMH, this intervention aimed at reducing the risk of suicide and suicidal behavior was trans-diagnostic. We term the intervention ASAP, with anticipated components: (1) Adherence-promoting engagement and adherence to treatment through motivational interviewing; (2) Safety planning; and (3) Affect Protection- selecting from a menu of techniques for maintaining positive affect (e.g. savoring and switching strategies, mobilizing social support, engaging in emotion regulation and distress tolerance skills). Each of these components was delivered within a Motivational Interviewing framework for enhancing intrinsic motivation for change. Treatment was brief (3-5 hours), and flexibly delivered on inpatient units prior to initiation of outpatient treatment. ASAP included the family in the treatment, and a safety plan phone app to extend the impact of treatment was also developed. Innovative features included: (1) delivery of an intervention at a time and place when suicidal risk is highest; (2) augmentation of protective factors against recurrent suicidal behavior, specifically by promoting development of positive affect, emotion regulation, distress tolerance, and social support; (3) a Safety plan phone app to extend the impact of treatment; and (4) liaison with the outpatient therapist to ensure continuity of care. This project conducted an RCT of ASAP followed by Aftercare (AC) vs. AC alone to determine ASAP's feasibility, acceptability, impact on proximal targets (e.g., adherence to outpatient care, sleep, positive affect, substance use), suicidal ideation and behavior. In total 68 suicidal adolescents were enrolled, 2 of whom were withdrawn following baseline assessment and were excluded from analyses, resulting in the final study sample size of 66. ASAP, developed with and intended for community clinicians, has the potential to be a sustainable intervention to reduce the burden of adolescent suicidality. Data analyses have been completed and results are being finalized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior
Keywords
adolescence, suicidality, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASAP Treatment and Brite
Arm Type
Experimental
Arm Description
Participants in the experimental arm received the ASAP treatment, during their transition from inpatient to outpatient care, as well as the Brite app for distress tolerance/emotion regulation and safety planning.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Participants in this grouping were studied as they proceed from inpatient to outpatient care, per usual treatment protocols at each site. Participants completed paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth.
Intervention Type
Behavioral
Intervention Name(s)
As Safe As Possible
Other Intervention Name(s)
ASAP
Intervention Description
The ASAP (As Safe As Possible) treatment is a brief, intensive intervention initiated during inpatient care and transitioning to outpatient care. The intervention focuses on 1) using motivational interviewing (MI) strategies throughout care; 2) developing a safety plan, including adapting the plan to an interactive safety plan phone app, Brite); and 3) using treatment modules to target specific risk factors that are selected based on individual need.
Intervention Type
Behavioral
Intervention Name(s)
Brite
Intervention Description
Brite is a HIPAA-compliant mobile application designed to provide the participants with emotion regulation and distress tolerance skills, social support, and convenient access to safety plan resources via the patients' phone.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Participants received usual treatment for suicidal adolescents as they transition from inpatient hospitalization to outpatient therapy, which included a paper safety plan.
Primary Outcome Measure Information:
Title
Suicidal behavior and ideation
Description
Suicidal attempts were the major outcome and secondarily, suicidal ideation. Information about past and current suicidal behavior was obtained using the Columbia Suicide History Form, with ideation and behavior classified using the Columbia Suicide Severity Rating Scale (CSSRS). Self-reported ideation was assessed using the Suicidal Ideation Questionnaire - Junior (SIQ-Jr). The two main outcomes, assessing recurrent suicidal behavior and change in suicidal ideation, was assessed at weeks 4, 12, and 24.
Time Frame
Weeks 4, 12, and 24
Secondary Outcome Measure Information:
Title
Course of disorder and AC treatment.
Description
Attendance to treatment and type of treatment was documented by the Treatment History Form. The electronic medical record and Youth Self Report will also be used to document the presence of psychiatric disorders. The Treatment History Form derives forms of treatment demonstrated on the Child and Adolescent Services Assessment (CASA) using the structure of the Adolescent Longitudinal Interval Follow-up (A-LIFE).
Time Frame
Weeks 4, 12, and 24
Title
Treatment target: motivation for treatment
Description
Participants rated readiness on a 1-10 scale to assess Readiness to change, Importance of change, and Confidence in ability To Change with regard to coping with suicidal urges [RICTC].
Time Frame
Weeks 4, 12, and 24
Title
Treatment target: positive and negative affect
Description
Positive and negative affect was monitored by the Positive and Negative Affect Scale [PANAS]).
Time Frame
Weeks 4, 12, and 24
Title
Treatment target: emotion regulation
Description
Emotion regulation was measured by the Regulation of Emotions Questionnaire.
Time Frame
Weeks 4, 12, and 24
Title
Treatment target: distress tolerance
Description
Distress tolerance was measured by the Distress Tolerance Scale.
Time Frame
Weeks 4, 12, and 24
Title
Treatment target: social support
Description
Perceived social support was assessed using the Multidimensional Scale of Perceived Social Support (MSPSS).
Time Frame
Weeks 4, 12, and 24
Title
Client Satisfaction
Description
Client Satisfaction about ASAP was obtained from the patient and a caretaking parent using the Client Satisfaction Questionnaire-8 (CSQ-8), which has been used in other adolescent treatment studies and has high internal consistency (coefficient α = .93). We also adapted the Computer System Usability Scale (CSUQ) to assess satisfaction with the phone app. The CSUQ was completed by the participant, and is based on earlier measures designed to predict the adoption of technology, based on two main factors: ease of use (easy to learn, access, flexibility, quality of sound, quality of visual display) and usefulness (able to access when needed, helpful when used), scored along 7-point Likert Scales.
Time Frame
Weeks 4, 12, and 24
Title
Qualitative Interviews
Description
With Dr. Lee's guidance, we conducted brief semi-structured exit interviews following the intervention with both the parent and teen, which were developed and coded on the basis of our original qualitative interviews, to assess the acceptability of treatment. In these interviews, we obtained feedback about perceived effectiveness of the components of treatment, the appropriateness of treatment targets, identification of other targets or approaches that would have been more helpful, barriers to participation, and utility of the phone apps. The phone app was designed to track how often the participant used the apps and what components were accessed. We obtained similar feedback from the ASAP clinicians and from the outpatient aftercare therapists. Based on exit interviews, participant satisfaction, and outcome data from the open trial, we modified the manual and app.
Time Frame
Weeks 4, 12, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child participants will be adolescents (aged 12-17.11 years) admitted to an inpatient unit for a recent suicide attempt or significant suicidal ideation with a plan or intent. We define a suicide attempt, as per the Columbia Clinical Algorithm for Suicide Assessment (C-CASA), as "self-destructive behavior with inferred or stated intent to die." Participants must be English-speaking. Participants can have unipolar or bipolar disorder, conduct or oppositional disorder, eating disorder, or alcohol or substance use or abuse or dependence. Exclusion Criteria: Child participants to be excluded will be those with current psychosis, mania, <90% of ideal body weight, or IQ<70 (based on the age-appropriate Wechsler Intelligence Scale if concerns about intellectual capabilities are evident at assessment), as these conditions may require more intensive interventions or limit comprehension of the intervention components.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brent, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26977137
Citation
Kennard BD, Biernesser C, Wolfe KL, Foxwell AA, Craddock Lee SJ, Rial KV, Patel S, Cheng C, Goldstein T, McMakin D, Blastos B, Douaihy A, Zelazny J, Brent DA. Developing a Brief Suicide Prevention Intervention and Mobile Phone Application: a Qualitative Report. J Technol Hum Serv. 2015 Oct 1;33(4):345-357. doi: 10.1080/15228835.2015.1106384. Epub 2015 Dec 14.
Results Reference
result
PubMed Identifier
30021457
Citation
Kennard BD, Goldstein T, Foxwell AA, McMakin DL, Wolfe K, Biernesser C, Moorehead A, Douaihy A, Zullo L, Wentroble E, Owen V, Zelazny J, Iyengar S, Porta G, Brent D. As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents. Am J Psychiatry. 2018 Sep 1;175(9):864-872. doi: 10.1176/appi.ajp.2018.17101151. Epub 2018 Jul 19. Erratum In: Am J Psychiatry. 2019 Sep 1;176(9):764.
Results Reference
result
PubMed Identifier
33677832
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
Results Reference
derived
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived

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Brief Intervention for Suicide Risk Reduction in High Risk Adolescents

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