Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01748760
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2012-12-11
Brief Title:
Coping Long Term With Attempted Suicide - Adolescents
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Coping Long Term With Attempted Suicide - Adolescents
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASP-A
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 hisher parentguardian in the hospital and c a series of scheduled telephone contacts with the patient and parentguardian 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
1 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
2 Develop and implement adherence and competence rating scales to evaluate provider adherence to the intervention manual and their competence in delivering the intervention
3 Improve the clarity structure content acceptability and feasibility of the intervention using information gathered from a small open trial n20 of adolescents ages 12-18 who have made a recent suicide attempt
The pilot study aims of this R34 proposal are to
1 Conduct a randomized controlled pilot study in a sample of adolescent inpatients n50 ages 12-18 with a recent suicide attempt to assess the feasibility and acceptability of the proposed intervention and the randomization process
2 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
1 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
2 lower suicidal ideation and less chronic suicidal ideation
3 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 ie 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 patientfamily 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 ie 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
The development aims of this R34 proposal are to
1 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
2 Develop and implement adherence and competence rating scales to evaluate provider adherence to the intervention manual and their competence in delivering the intervention
3 Improve the clarity structure content acceptability and feasibility of the intervention using information gathered from a small open trial n20 of adolescents ages 12-18 who have made a recent suicide attempt
The pilot study aims of this R34 proposal are to
1 Conduct a randomized controlled pilot study in a sample of adolescent inpatients n50 ages 12-18 with a recent suicide attempt to assess the feasibility and acceptability of the proposed intervention and the randomization process
2 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
1 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
2 lower suicidal ideation and less chronic suicidal ideation
3 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 ie 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 patientfamily 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None