NCT01925807

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

3.2 years

First QC Date

August 14, 2013

Last Update Submit

August 10, 2017

Conditions

Keywords

AdolescentSuicidal IdeationEmergency DepartmentCrisisAttachmentCoping

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (1)

  • Familial Support

    6 weeks

Other Outcomes (3)

  • Coping Strategies

    6 weeks

  • Depression

    6 weeks

  • Anxiety

    6 weeks

Study Arms (1)

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.

Behavioral: Group Intervention

Interventions

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.

Group Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of a suicidal plan and/or recent gesture/attempt
  • Psychosis
  • Schizophrenia
  • Dual diagnosis
  • Developmental disability or delay
  • "Behavioural problem" as primary concern
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

Related Publications (9)

  • 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.

    PMID: 20215934BACKGROUND
  • Rathus 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.

    PMID: 12079031BACKGROUND
  • Armsden 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.

    PMID: 24277469BACKGROUND
  • Cloutier, 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.

    BACKGROUND
  • Kovacs, M. (2010). Children's Depression Inventory Manual. Toronto, ON: Multi-Health Systems Inc.

    BACKGROUND
  • March, J.S. (2013). Manual for the Multidimensional Anxiety Scale for Children - 2nd Edition (MASC-2). Toronto, ON: MHS Inc.

    BACKGROUND
  • Moos, R. H., & Moos, B. S. (1981). Family environment scale manual

    BACKGROUND
  • Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).

    BACKGROUND
  • Griffine, D. W., & Garthholomew, K. (1994). The metaphysics of measurement: The case of adult attachment. (pp. 17-52).

    BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationEmergencies

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Allison Kennedy, Ph.D.

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 20, 2013

Study Start

February 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations