Suicidal IdeationBRAVANCT01925807
Building Resilience and Attachment in Vulnerable Adolescents
A study testing Group Intervention in people with Suicidal Ideation, run by Allison Kennedy at 1 site in Canada.
Trial summary
Suicide is the second leading cause of mortality for Canadian adolescents. Mental health complaints are one of the leading reasons for an emergency department visit at the Children's Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mild to moderate suicidal ideation
- Recently presented for services in response to a psycho-social crisis (Emergency Department, MH Urgent Care)
- One or two caregiver(s) committed to attending the majority of sessions
Who cannot join
- Presence of a suicidal plan and/or recent gesture/attempt
- Psychosis
- Schizophrenia
- Dual diagnosis
- Developmental disability or delay
- "Behavioural problem" as primary concern
Show all 11Show fewer
- Major substance abuse
- Currently receiving mental health services (once every two weeks or more frequently)
- Inability to commit to majority of sessions (minimum 4 of 6 sessions)
- Children's aid society involvement
- Inability of at least one caregiver to commit to attending the majority of sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Group Intervention for Adolescents With Mild to Moderate Suicidal Ideation and Their Caregivers: Preliminary Investigation for a Novel Treatment Approach
Suicide is the second leading cause of mortality for Canadian adolescents. Mental health complaints are one of the leading reasons for an emergency department visit at the Children's Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the present investigation is to test the efficacy of a brief group intervention for adolescents with passive suicidal ideation and their caregivers that will focus on coping, familial support, and emotional regulation. The investigators hypothesize that a brief group intervention, delivered in the weeks following presentation for crisis services, will reduce suicidal ideation and improve coping and familial support.
- Conditions
- Suicidal Ideation
- Being tested
- Group Intervention
- Keywords
- Adolescent, Suicidal Ideation, Emergency Department, Crisis, Attachment, Coping
- Medical subject headings
- Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group InterventionBehavioural
The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation.
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention | Experimental | The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation. Receives: Behavioral: Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation
Suicidal ideation will be measured using the Suicidal Ideation Questionnaire Junior (SIQ-JR; Reynolds, 1988).
Repeated Measures ANOVA or ANCOVA will be used to compare differences in suicidal ideation within groups (pre-post changes). Further comparisons using clinical cut-off will be conducted via McNemar test for matched pairs.
Measured: 6 weeks
Secondary outcomes (1)
Familial Support
Familial support will be measured using questionnaires for both caregivers and youth. Youth will respond to the Family Environment Scale (Koren, DeChillo, \& Friesen, 1992) and the Inventory of Parent and Peer Attachment (Armsden \& Greenberg, 1987). Caregivers will respond to the Family Environment Scale and and Relationship Scale Questionnaire (Griffine \& Gartholomew, 1994).
Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allison Kennedy
- Sponsor type
- University, hospital or other
- Collaborators
- Mach Gaensslen Foundation, AFP Innovation Fund
- Responsible party
- Sponsor-investigator, Allison Kennedy, Children's Hospital of Eastern Ontario
- Investigators
- Allison Kennedy, Ph.D., Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925807
- Sponsor's protocol ID
- CHAMO_SI_Group_001
- Acronym
- BRAVA
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2013
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Diamond GS, Wintersteen MB, Brown GK, Diamond GM, Gallop R, Shelef K, Levy S. Attachment-based family therapy for adolescents with suicidal ideation: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):122-31. doi: 10.1097/00004583-201002000-00006.
PubMed 20215934Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.
PubMed 12079031Armsden GC, Greenberg MT. The inventory of parent and peer attachment: Individual differences and their relationship to psychological well-being in adolescence. J Youth Adolesc. 1987 Oct;16(5):427-54. doi: 10.1007/BF02202939.
PubMed 24277469Cloutier, P. F., Kennedy, A., & Glennie, E. (2008, June). Coping behaviors and intensity of non-suicidal self-harm in Canadian adolescents presenting to emergency mental health services. Poster presented at the third annual meeting of the International Society for the Study of Self-Injury (ISSS), Harvard University, Cambridge, MA.
Kovacs, M. (2010). Children's Depression Inventory Manual. Toronto, ON: Multi-Health Systems Inc.
March, J.S. (2013). Manual for the Multidimensional Anxiety Scale for Children - 2nd Edition (MASC-2). Toronto, ON: MHS Inc.
Moos, R. H., & Moos, B. S. (1981). Family environment scale manual
Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
Griffine, D. W., & Garthholomew, K. (1994). The metaphysics of measurement: The case of adult attachment. (pp. 17-52).
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Group Intervention for Adolescents With Mild to Moderate Suicidal Ideation and Their Caregivers: Preliminary Investigation for a Novel Treatment Approach
- ClinicalTrials.gov ID
- NCT01925807
- Acronym / sponsor ID
- BRAVA / CHAMO_SI_Group_001
- Conditions
- Suicidal Ideation
- Keywords
- Adolescent, Suicidal Ideation, Emergency Department, Crisis, Attachment, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Allison KennedyUniversity, hospital or other
- Collaborators
- Mach Gaensslen Foundation, AFP Innovation Fund
- Study start
- Feb 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suicide is the second leading cause of mortality for Canadian adolescents. Mental health complaints are one of the leading reasons for an emergency department visit at the Children's Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the present investigation is to test the efficacy of a brief group intervention for adolescents with passive suicidal ideation and their caregivers that will focus on coping, familial support, and emotional regulation. The investigators hypothesize that a brief group intervention, delivered in the weeks following presentation for crisis services, will reduce suicidal ideation and improve coping and familial support.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Intervention | Experimental | Behavioral: Group InterventionThe intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mild to moderate suicidal ideation
- Recently presented for services in response to a psycho-social crisis (Emergency Department, MH Urgent Care)
- One or two caregiver(s) committed to attending the majority of sessions
Key exclusion criteria (11 listed)
- Presence of a suicidal plan and/or recent gesture/attempt
- Psychosis
- Schizophrenia
- Dual diagnosis
- Developmental disability or delay
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 |
|---|---|---|
| Group InterventionThe intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation. | Behavioural | Group Intervention |
Primary outcome
Suicidal Ideation
Time frame: 6 weeks
Suicidal ideation will be measured using the Suicidal Ideation Questionnaire Junior (SIQ-JR; Reynolds, 1988). Repeated Measures ANOVA or ANCOVA will be used to compare differences in suicidal ideation within groups (pre-post changes). Further comparisons using clinical cut-off will be conducted via McNemar test for matched pairs.
1 secondary outcome
Familial Support
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Background: PubMed 20215934Diamond GS, Wintersteen MB, Brown GK, Diamond GM, Gallop R, Shelef K, Levy S. Attachment-based family therapy for adolescents with suicidal ideation: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):122-31. doi: 10.1097/00004583-201002000-00006.
- Background: PubMed 12079031Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.
- Background: PubMed 24277469Armsden GC, Greenberg MT. The inventory of parent and peer attachment: Individual differences and their relationship to psychological well-being in adolescence. J Youth Adolesc. 1987 Oct;16(5):427-54. doi: 10.1007/BF02202939.
- BackgroundCloutier, P. F., Kennedy, A., & Glennie, E. (2008, June). Coping behaviors and intensity of non-suicidal self-harm in Canadian adolescents presenting to emergency mental health services. Poster presented at the third annual meeting of the International Society for the Study of Self-Injury (ISSS), Harvard University, Cambridge, MA.
- BackgroundKovacs, M. (2010). Children's Depression Inventory Manual. Toronto, ON: Multi-Health Systems Inc.
- BackgroundMarch, J.S. (2013). Manual for the Multidimensional Anxiety Scale for Children - 2nd Edition (MASC-2). Toronto, ON: MHS Inc.
- BackgroundMoos, R. H., & Moos, B. S. (1981). Family environment scale manual
- BackgroundReynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
- BackgroundGriffine, D. W., & Garthholomew, K. (1994). The metaphysics of measurement: The case of adult attachment. (pp. 17-52).
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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.
Allison Kennedy, Ph.D. principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Intervention in people with Suicidal Ideation, run by Allison Kennedy at 1 site in Canada.
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 3 inclusion and 11 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 14 Aug 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Suicidal Ideation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01925807, which also lists 9 linked publications.
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 14 Aug 2017.