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| Name | Class |
|---|---|
| Butler Hospital | OTHER |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLASP-A intervention | Experimental | Adolescent participants and parents will receive adjunctive psychosocial intervention. |
|
| Treatment as Usual | Active Comparator | Adolescent participants and parents will not receive study intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLASP-A intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Yen, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
Please contact PI for data.
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Adolescent Psychiatric Inpatient Unit
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| ID | Title | Description |
|---|---|---|
| FG000 | CLASP-A Intervention | Adolescent participants and parents will receive adjunctive psychosocial intervention. CLASP-A intervention: 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. |
| FG001 | Treatment as Usual | Adolescent participants and parents will not receive study intervention Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CLASP-A Intervention | Adolescent participants and parents will receive adjunctive psychosocial intervention. CLASP-A intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLASP-A Intervention | Adolescent participants and parents will receive adjunctive psychosocial intervention. CLASP-A intervention: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Non lethal suicide attempts and subsequent psychiatric hospitalization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shirley Yen, Ph.D. | Brown University | 401-444-1915 | Shirley_Yen_PhD@Brown.edu |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Other | Referral to outpatient treatment as part of routine discharge planning. |
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| BG001 | Treatment as Usual | Adolescent participants and parents will not receive study intervention Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Number | participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 11 |
| 19 |
| 0 |
| 19 |
| EG001 | Treatment as Usual | Adolescent participants and parents will not receive study intervention Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning. | 9 | 23 | 0 | 23 |
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| Hospitalization for suicidal ideation | Psychiatric disorders |
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| ED visit for suicidal ideation | Psychiatric disorders |
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| ED for drug overdose | Psychiatric disorders |
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| ED for medical evaluation (e.g. frostbite) | Skin and subcutaneous tissue disorders |
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| Legal Issues | Social circumstances |
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