SuicideCLASP-ANCT01748760
Coping Long Term With Attempted Suicide - Adolescents
A study testing CLASP-A intervention and Treatment as Usual in people with Suicide, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicide
- What is being tested?
- CLASP-A intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admission to an inpatient unit due to suicide risk
- English speaking
Who cannot join
- Active psychosis
- Cognitive Disability
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- CLASP-A intervention, Treatment as Usual
- Keywords
- Suicide Attempts, Suicidal Ideation
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLASP-A interventionBehavioural
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.
Treatment as UsualOther
Referral to outpatient treatment as part of routine discharge planning.
| Study group | Role | What they receive |
|---|---|---|
| CLASP-A intervention | Experimental | Adolescent participants and parents will receive adjunctive psychosocial intervention. Receives: Behavioral: CLASP-A intervention |
| Treatment as Usual | Active comparator | Adolescent participants and parents will not receive study intervention Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Butler Hospital
- Responsible party
- Principal investigator, Shirley Yen, Brown University
- Investigators
- Shirley Yen, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748760
- Sponsor's protocol ID
- R34MH090147
- Acronym
- CLASP-A
- Status last verified
- Sep 2016
- First submitted
- 11 Dec 2012
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Please contact PI for data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Long Term With Attempted Suicide - Adolescents
- ClinicalTrials.gov ID
- NCT01748760
- Acronym / sponsor ID
- CLASP-A / R34MH090147
- Conditions
- Suicide
- Keywords
- Suicide Attempts, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Butler Hospital
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 13 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLASP-A intervention | Experimental | Behavioral: CLASP-A interventionAdolescent participants and parents will receive adjunctive psychosocial intervention. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualAdolescent participants and parents will not receive study intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Admission to an inpatient unit due to suicide risk
- English speaking
Key exclusion criteria (2 listed)
- Active psychosis
- Cognitive Disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLASP-A interventionThree 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. | Behavioural | CLASP-A intervention |
| Treatment as UsualReferral to outpatient treatment as part of routine discharge planning. | Other | Treatment as Usual |
Primary outcome
Number of Participants Who Repoorted a Suicide Event
Time frame: 6 months
A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Please contact PI for data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Yen, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLASP-A intervention and Treatment as Usual in people with Suicide, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Repoorted a Suicide Event (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.