Coping Long Term With Attempted Suicide - Adolescents (CLASP-A)
Primary Purpose
Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLASP-A intervention
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Suicide focused on measuring Suicide Attempts, Suicidal Ideation
Eligibility Criteria
Inclusion Criteria:
- Admission to an inpatient unit due to suicide risk
- English speaking
Exclusion Criteria:
- Active psychosis
- Cognitive Disability
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CLASP-A intervention
Treatment as Usual
Arm Description
Adolescent participants and parents will receive adjunctive psychosocial intervention.
Adolescent participants and parents will not receive study intervention
Outcomes
Primary Outcome Measures
Number of Participants Who Repoorted a Suicide Event
A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.
Secondary Outcome Measures
Full Information
NCT ID
NCT01748760
First Posted
December 11, 2012
Last Updated
November 17, 2016
Sponsor
Brown University
Collaborators
Butler Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01748760
Brief Title
Coping Long Term With Attempted Suicide - Adolescents
Acronym
CLASP-A
Official Title
Coping Long Term With Attempted Suicide - Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
Butler Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to develop an adjunctive intervention for acutely suicidal adolescents who have been admitted to a psychiatric inpatient unit. The study intervention is comprised of: 1) two to three individual sessions delivered in an inpatient setting or immediately upon discharge; 2) one family session; 3) six months of follow-up phone interventions. The investigators hypothesize that those who receive the study intervention will have lower rates of suicide events and greater decreases in suicidal ideation after six months.
Detailed Description
The purpose of this R34 treatment development grant is to develop the "Coping Long-term with Attempted Suicide Program - Adolescents (CLASP-A)," an integrated, adjunctive intervention program for adolescents who have made a previous suicide attempt. The goals of CLASP-A are to reduce continued suicidal behavior and ideation, reduce risk behaviors for suicide, and improve adherence to psychosocial and psychopharmacologic treatments. It is comprised of three major components: a) three individual meetings while the patient is in the hospital, b) one in-person meeting with the patient and his/her parent/guardian in the hospital and c) a series of scheduled telephone contacts with the patient and parent/guardian for six months following discharge from the hospital. CLASP-A is based on a risk reduction model, and specifically targets four generic and potentially modifiable risk factors: hopelessness, impaired family support, problem solving deficits, and treatment non-adherence. The overall aim of this proposal is to further develop the CLASP-A intervention to address the needs of adolescents and to examine the feasibility and acceptability of this intervention program in adolescents. More specifically:
The development aims of this R34 proposal are to:
Develop CLASP-A - a multi-modal intervention that integrates strategies from cognitive-behavioral and values-based psychotherapies and family interventions, for use with suicidal adolescents.
Develop and implement adherence and competence rating scales to evaluate provider adherence to the intervention manual and their competence in delivering the intervention.
Improve the clarity, structure, content, acceptability, and feasibility of the intervention using information gathered from a small open trial (n=20) of adolescents, ages 12-18, who have made a recent suicide attempt.
The pilot study aims of this R34 proposal are to:
Conduct a randomized controlled pilot study in a sample of adolescent inpatients (n=50), ages 12-18, with a recent suicide attempt to assess the feasibility and acceptability of the proposed intervention and the randomization process.
To examine in an exploratory manner, preliminary evidence for the following hypotheses. It is expected that over a 6 month intervention period, compared to an enhanced treatment as usual (E-TAU) condition, adolescents assigned to CLASP-A + ETAU will have:
fewer suicidal events, operationalized as a dichotomous composite score of suicide attempts, emergency department visits and inpatient hospital admissions due to suicide risk, and study rescue procedures due to suicide risk;
lower suicidal ideation and less chronic suicidal ideation;
To examine in exploratory analyses potential mechanisms of change including treatment adherence to other forms of treatment as well as improvement in the hypothesized risk factors (i.e., hopelessness, problem-solving, and family functioning) addressed in the intervention.
Based on the findings, CLASP-A will be revised, with the objective of creating a flexible protocol in which emphasis can be shifted based on the presenting problems of the patient/family, and strategies can be selected to accommodate the developmental stage of the patient. CLASP-A is innovative in that it targets the highest risk adolescents during their highest risk period, i.e. transition from inpatient to outpatient care. It is also innovative in employing multiple modalities (in-person sessions and phone calls) that involve both the patient and the parent, thus targeting frequently cited barriers in the treatment of adolescent patients. The availability of a low-cost, easily implemented, adjunctive intervention that successfully reduces the rate of suicide attempts in adolescents could improve quality of life and productivity on both individual and societal levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide Attempts, Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLASP-A intervention
Arm Type
Experimental
Arm Description
Adolescent participants and parents will receive adjunctive psychosocial intervention.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Adolescent participants and parents will not receive study intervention
Intervention Type
Behavioral
Intervention Name(s)
CLASP-A intervention
Intervention Description
Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Referral to outpatient treatment as part of routine discharge planning.
Primary Outcome Measure Information:
Title
Number of Participants Who Repoorted a Suicide Event
Description
A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admission to an inpatient unit due to suicide risk
English speaking
Exclusion Criteria:
Active psychosis
Cognitive Disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Yen, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Please contact PI for data.
Learn more about this trial
Coping Long Term With Attempted Suicide - Adolescents
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