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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01925807
Other study ID # CHAMO_SI_Group_001
Secondary ID
Status Completed
Phase N/A
First received August 14, 2013
Last updated August 10, 2017
Start date February 2014
Est. completion date May 2017

Study information

Verified date August 2017
Source Children's Hospital of Eastern Ontario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group Intervention
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.

Locations

Country Name City State
Canada Children's Hospital of Eastern Ontario Ottawa Ontario

Sponsors (3)

Lead Sponsor Collaborator
Allison Kennedy AHSC AFP Innovation Fund, Mach Gaensslen Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

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.

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. — View Citation

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

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

Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Coping Strategies Youth coping strategies will be measured using the Youth Stress and Coping Questionnaire (Cloutier et al., 2008).
Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
6 weeks
Other Depression Youth depression will be measured using the Children's Depression Inventory-2 Self report (CDI-2; Kovaks, 2010).
Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
6 weeks
Other Anxiety Youth anxiety symptoms will be measured using the Multidimensional Anxiety Scale for Children (MASC-2; March, 1997).
Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
6 weeks
Primary 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 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).
6 weeks
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