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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272179
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
David Brent, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 20, 2014
First Posted Date  ICMJE October 22, 2014
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
Suicidal behavior and ideation [ Time Frame: Weeks 4, 12, and 24 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Suicidal ideation and behavior. [ Time Frame: Weeks 4, 12, and 24 ]
Information about past and current suicidal behavior and non-suicidal self-injury will be obtained using the Columbia Suicide History Form, with ideation and behavior classified using the Columbia Suicide Severity Rating Scale (C-SSRS). Self-reported ideation will be assessed using the Suicidal Ideation Questionnaire - Junior (SIQ-Jr). The two main outcomes, assessing recurrent suicidal behavior and change in suicidal ideation, to be assessed at weeks 4, 12, and 24.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Course of disorder and AC treatment. [ Time Frame: Weeks 4, 12, and 24 ]
    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 [ Time Frame: Weeks 4, 12, and 24 ]
    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 [ Time Frame: Weeks 4, 12, and 24 ]
    Positive and negative affect was monitored by the Positive and Negative Affect Scale [PANAS]).
  • Treatment target: emotion regulation [ Time Frame: Weeks 4, 12, and 24 ]
    Emotion regulation was measured by the Regulation of Emotions Questionnaire.
  • Treatment target: distress tolerance [ Time Frame: Weeks 4, 12, and 24 ]
    Distress tolerance was measured by the Distress Tolerance Scale.
  • Treatment target: social support [ Time Frame: Weeks 4, 12, and 24 ]
    Perceived social support was assessed using the Multidimensional Scale of Perceived Social Support (MSPSS).
  • Client Satisfaction [ Time Frame: Weeks 4, 12, and 24 ]
    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 [ Time Frame: Weeks 4, 12, and 24 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
  • Course of disorder and AC treatment. [ Time Frame: Weeks 4, 12, and 24 (A-LIFE Week 24 only) ]
    Attendance to treatment and type of treatment will be documented by the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) and Child and Adolescent Services Assessment (CASA). The A-LIFE will also be used to document the course of ongoing psychiatric disorders. The CASA is commonly used for assessing service use for health economic evaluations.
  • Treatment targets of the intervention are motivation for treatment, positive affect, sleep, drug and alcohol use, and perceived support. [ Time Frame: Weeks 4, 12, and 24 ]
    Participants will use readiness rulers (1-10 scale) to rate Readiness to change, Importance of change, and Confidence in ability To Change with regard to coping with suicidal urges [RICTC], positive and negative affect is monitored by the Positive and Negative Affect Scale [PANAS]); sleep by the Insomnia Severity Index [ISI]); drug and alcohol use by the TLFB; support by the Perceived Emotional / Personal Support Scale [PEPSS] and Family Adaptability and Cohesion Evaluation Scale [FACES-IV]).
  • Client Satisfaction [ Time Frame: Weeks 4, 12, and 24 ]
    Client Satisfaction about ASAP will be 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 adapt the Post-Study Satisfaction and Usability Questionnaire (PSSUQ) to assess satisfaction with the phone app. The PSSUQ will be filled out 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 [ Time Frame: Weeks 4, 12, and 24 ]
    With Dr. Lee's guidance, we will conduct brief semi-structured exit interviews following the intervention with both the parent and teen, which will be developed and coded on the basis of our original qualitative interviews, to assess the acceptability of treatment. In these interviews, we will obtain 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 will be designed to track how often they were used. We will obtain 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, the manual and app can be modified.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Intervention for Suicide Risk Reduction in High Risk Adolescents
Official Title  ICMJE Brief Intervention for Suicide Risk Reduction in High Risk Adolescents
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adolescent Behavior
Intervention  ICMJE
  • Behavioral: As Safe As Possible
    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.
    Other Name: ASAP
  • Behavioral: Brite
    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.
  • Behavioral: Treatment as Usual
    Participants received usual treatment for suicidal adolescents as they transition from inpatient hospitalization to outpatient therapy, which included a paper safety plan.
Study Arms  ICMJE
  • Experimental: ASAP Treatment and Brite
    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.
    Interventions:
    • Behavioral: As Safe As Possible
    • Behavioral: Brite
  • Active Comparator: Treatment as Usual
    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: Behavioral: Treatment as Usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2018)
68
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2014)
110
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272179
Other Study ID Numbers  ICMJE R34MH100451( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Brent, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE University of Texas Southwestern Medical Center
Investigators  ICMJE
Principal Investigator: David Brent, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP