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SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning (SAFER)

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ClinicalTrials.gov Identifier: NCT03034863
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE January 11, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE July 3, 2017
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Beck Scale for Suicidal Ideation [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Suicidality will be measured using the Beck Scale for Suicide Ideation (BSS), a 21-item self-report scale designed to assess severity of suicidal attitudes and plans for suicide. The BSS is internally consistent (Cronbach's coefficients range from .87-.97) and has been used extensively in treatment studies for suicidal individuals, including recent studies. A principal components factor analysis identified 3 factors for the BSS: desire for death, preparation for suicide and actual suicide desire.
  • Caregiver Burden Inventory [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Caregiver burden will be evaluated by the Caregiver Burden Inventory (CBI), a 24-item scale assessing caregiver burden in four areas: physical, social, emotional and time dependence burden. Investigators found a large effect size in the pilot multifamily group study on this scale (Cohen's d = 1.03).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03034863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Beck Hopelessness Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Suicidal cognitions and coping measures are: hopelessness, perceived burdensomeness and thwarted belongingness, suicide-related coping and use of social supports. Hopelessness will be assessed with the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients.
  • Suicide Related Coping Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner & Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: "I am at the mercy of my suicidal thoughts", "I have several things I can do to get through a suicidal crisis".
  • Interpersonal Needs Questionnaire [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Perceived burden and thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-12). The INQ is has demonstrated good internal consistency for both thwarted belongingness TB ( =.85) and Perceived Burdensomeness (PB) ( = .89).
  • Beck Depression Inventory-II [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Veteran mental health will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92).
  • Columbia Suicide Severity Rating Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The Columbia Suicide Severity Rating Scale (C-SSRS) will record lifetime suicide attempts & methods, including lethality, precipitant and surrounding circumstances. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies.
  • Family Empowerment Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    In addition, caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies.
  • Short-Form Health Survey (SF-8) [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Veteran health will be evaluated by the 8-item Short-Form Health Survey (SF-8) which assesses self-reported general health, physical functioning, role limitations due to physical health problems, bodily pain and vitality.
  • Self-Harm and Suicide Disclosure Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The Self-Harm and Suicide Disclosure Scale will be used to assess the degree to which Veterans disclose past suicide-type harming behavior to their family. Veterans are first asked to select a family member with whom they talk the most about life's challenges. Then, they are asked to indicate whether they had shared each of ten possible topics with the target family member, such as "when I am thinking about hurting myself on purpose" or "the reason why I attempted suicide." Response options are no (0) and yes (1).
  • Family Quality Reaction Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The Family Quality Reaction Scale (FQRS) measures how the target family member's reaction to suicide disclosure was perceived. Veterans are asked the degree to which they agree with five statements regarding the target family member's reaction to their suicide disclosure, such as "I felt more comfortable with this person after I told him or her." Response options range from strongly disagree (1) to strongly agree (4), and total scores are summed with higher scores indicating more positive reactions to suicide disclosure. Internal reliability of this scale yielded a Cronbach's alpha of .87.
  • PROMIS Pain Interference - Short Form [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The 6-item Pain Interference Short Form (PROMIS PI-SF) from PROMIS will be used to assess important health domains not addressed by the SF-8.
  • Insomnia Severity Index [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The 7-item Insomnia Severity Index (ISI) will be used to assess important health domains not addressed by the SF-8.
  • Family Suicide-related Coping Measure [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    We have developed a family counterpart to the Stanley Suicide-related Coping Scale for Veterans that taps family members' appraisal of their ability to participate effectively in Veteran safety planning. Items include, "I recognize the triggers and warning signs for suicidal ideation/urges for my Veteran" and "I know the numbers for the mobile crisis team to contact and nearest hospital or urgent care facility to accompany my Veteran to in a crisis." This measure will be validated against the more general Family Empowerment Scale.
  • Devaluation of Consumer Families Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Family members will complete the Devaluation of Consumer Families Scale (DCFS) (counterpart to DCS).
  • Family Assessment Device [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The Family Assessment Device (FAD), based on the McMaster Model of Family Functioning (MMFF), will measure structural, organizational, and transactional characteristics of families. It consists of 6 scales that assess the 6 dimensions of the MMFF - affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles - as well as a 7th scale measuring general family functioning. For the purposes of this study, we will only administer the communication and problem-solving scales. Veterans are asked to rate how well each statement describes their own family. The FAD is scored by adding the responses (1-4) for each scale and dividing by the number of items in each scale (6-12). Higher scores indicate worse levels of family functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Beck Hopelessness Inventory [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Suicidal cognitions and coping measures are: hopelessness, perceived burdensomeness and thwarted belongingness, suicide-related coping and use of social supports. Hopelessness will be assessed with the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients.
  • Stanley Suicide-related Coping Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner & Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: "I am at the mercy of my suicidal thoughts", "I have several things I can do to get through a suicidal crisis".
  • Interpersonal Needs Questionnaire [ Time Frame: CChange from baseline to 1 month; change from 1 month to 3 months ]
    Perceived burden and thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-12). The INQ is has demonstrated good internal consistency for both thwarted belongingness TB ( =.85) and Perceived Burdensomeness (PB) ( = .89).
  • PROMIS Emotional Support & Abbreviated Duke Social Support Scale [ Time Frame: CChange from baseline to 1 month; change from 1 month to 3 months ]
    The 4-item short form of the PROMIS Emotional Support Scale will be used to evaluate subjective social support, a well-established buffer against severity of depressive symptoms over time, and a specific treatment target for the SAFER intervention. In addition, the first 5 -items from the Abbreviated Duke Social Support Scale will be used to measure social network interactions, i.e., telephone and face-to-face interaction patterns and attendance at clubs and religious events during the past week outside of work. This aspect of social support, not included in the PROMIS, was found to increase dramatically in the pilot MFG study described above (Cohen's d = .85).
  • Beck Depression Inventory [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Veteran mental health will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92).
  • Columbia Suicide History Form [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The Columbia Suicide History Form (CSHF) will record lifetime suicide attempts & methods, including lethality, precipitant and surrounding circumstances. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies.
  • Family Empowerment Scale [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    In addition, caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies.
  • Communication Patterns Questionnaire [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    The Communication Patterns Questionnaire (CPQ) will be used to evaluate changes in communication patterns resulting from communication skills training which is a core intervention component of SAFER. The CPQ evaluates three factor-analytically-derived types of communication patterns dyads employ during a discussion: Conflict, Demand-Withdraw and Positive Interaction. Individual scores from each member of dyad are combined to derive scores on each of these communication patterns. Heavey et al. (54) found high internal consistency with Cronbach's 's between .81 and .84.
  • Short-Form Health Survey [ Time Frame: Change from baseline to 1 month; change from 1 month to 3 months ]
    Veteran health will be evaluated by the 8-item Short-Form Health Survey (SF-8) which assesses self-reported general health, physical functioning, role limitations due to physical health problems, bodily pain and vitality.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning
Official Title  ICMJE SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning
Brief Summary The management of suicide risk is a pressing national public health issue especially among Veterans, and there exist no guidelines of how best to involve family members in this effort. This proposal will integrate family and couples communication skills training with suicide safety planning. The goal is for the sharing of Veteran suicide safety plans with family members and the construction of a parallel family member safety plan, in efforts to mobilize and support family involvement.
Detailed Description

Psychological models of suicidality emphasize the role of social factors in the development and intensification of suicidal thoughts and behavior, including feeling like a burden on family and friends, feelings of isolation and not belonging, and perceptions of diminished support from one's family and social network. Despite the critical role of family factors in protecting against suicidality, families lack education on how their behavior can help avert or unwittingly aggravate suicidal thoughts/ behavior. Families worry about their relative but feel uncertain of how to help and need professional guidance. Family worries about suicidality are associated with compromised family physical and mental health and consequently, diminished ability to offer needed support. Because suicide safety plans rely on mobilizing support in times of crisis, families need to be equipped to provide needed support.

Family recommendations from the VA Behavioral Health Autopsy Program (BHAP) Annual Report 6/30/15 based on interviews with 114 family members highlighted the importance of:

  1. educating families about suicide warning signs:
  2. improving communication between the veteran and family member
  3. involving the family in the veterans' treatment to enhance support and trust
  4. providing families with coaching on how to assist their loved one to seek help.

Management of suicidal behavior is covered in comprehensive family psychoeducation programs, but there is an urgent need for a brief family-based intervention specifically focused on suicide prevention that can be used in conjunction with the currently mandated SSP and as a part of routine care.

Despite the enrichment of VA suicide prevention services and implementation of the national suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts numbered over 15,000 in 2012. These data underscore the urgency of developing additional interventions targeting suicidal Veterans. One potential avenue to further suicide treatment and rehabilitation efforts is to develop strategies that maximize family support, however almost no family interventions exist for suicidal Veterans. The construction of a Suicide Safety Plan (SSP); a "best practice," is mandated throughout the VA system, and a vital component of the VA's coordinated effort at suicide prevention and recovery. The pilot data on patterns of SSP use in suicidal Veterans highlighted the importance of sharing the plan with family or close friends. However, respondents also noted significant obstacles in their ability to reach out to others when in distress. To the knowledge of Investigators, there are currently no recommended guidelines or mechanisms for involving family in safety planning, despite its inclusion as a step of the plan. "Safe Actions for Families to Encourage Recovery" (SAFER) a novel suicide safety planning family intervention has been designed to fill this critical gap and provide a mechanism to communicate about safety planning. SAFER, a 4-session, family intervention, combines education about suicide and suicide safety planning with communication skills training from evidence-based practices. The aim is to facilitate communication about suicide safety planning and to develop both a Veteran and family member safety plan.

Data from this project will test the intervention's feasibility, acceptability and preliminary efficacy in a Stage II small-scale randomized clinical trial in 60 moderate suicide risk Veterans and their family members. The comparison condition will be safety planning without family involvement plus weekly check-in phone calls. Primary Veteran outcomes include reducing suicidal ideation/behavior. Secondary Veteran outcomes include reducing suicidal cognitions (hopelessness, perceived burdensomeness, thwarted belongingness) and depression and improving subjective social support. Family member primary outcomes include reducing caregiver burden and secondary outcomes of improving suicide-related coping and family empowerment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Masking Description:
The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.
Primary Purpose: Treatment
Condition  ICMJE Suicide
Intervention  ICMJE
  • Behavioral: Safe Actions for Families to Encourage Recovery
    A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
    Other Name: SAFER
  • Behavioral: Treatment-as-Usual
    The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).
    Other Name: TAU
Study Arms  ICMJE
  • Experimental: Treatment
    SAFER: A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
    Intervention: Behavioral: Safe Actions for Families to Encourage Recovery
  • Active Comparator: Control
    The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating weekly scripted check-in phone calls to review mood symptoms and use of the safety plan, which will then be given as feedback to the Veteran?s primary mental health provider.
    Intervention: Behavioral: Treatment-as-Usual
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria-Veterans:

  • Eligible Veterans must be identified as at moderate risk for suicide, defined as:

    • evidence of current (within the past week) suicidal ideation
    • plan or intent on the Columbia Suicide Severity Rating Scale (C-SSRS), but scoring less than or equal to 4 on the C-SSRS Behavior Scale, and without history of a lethal suicide attempt in the last 3 months.

Inclusion criteria also include the availability of a consenting, qualifying family member or spouse/cohabiting partner.

Inclusion criteria-family member/significant others:

  • Family members/friends must meet at least three (two for nonrelatives) of five criteria:

    • is a spouse, co-habiting significant other or parent
    • has more frequent contact than any other caregiver
    • helps to support the patient financially
    • is contacted by treatment staff for emergencies
    • has been involved in the patient's treatment

Exclusion Criteria:

Exclusion criteria for Veterans and family/partners are:

  • untreated or un-medicated psychosis
  • current alcohol or drug abuse or dependence defined by a PHQ for Alcohol & Drug Use
  • for couples, "severe" intimate-partner violence as defined by the revised 20-item Conflict Tactics Scale Short Form (CTS2S)
  • medical condition or life event, e.g.,
  • participation in another family-based psychosocial intervention trial six months prior to study
  • limited English proficiency. Participants will be screened for inclusion/exclusion as described above immediately after giving consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marianne S Goodman, MD (718) 584-9000 ext 5188 marianne.goodman@va.gov
Contact: Sarah R Sullivan (718) 584-9000 Sarah.Sullivan@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034863
Other Study ID Numbers  ICMJE D2432-R
RX002432-01 ( Other Grant/Funding Number: VA ORD )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marianne S. Goodman, MD James J. Peters Veterans Affairs Medical Center
PRS Account VA Office of Research and Development
Verification Date October 2019

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