Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child - Full Text View

Sponsors and Collaborators:	Herzog Hospital Mount Sinai School of Medicine
Information provided by:	Herzog Hospital
ClinicalTrials.gov Identifier:	NCT00447174

Purpose

Develop a treatment for clinically significant parental bereavement. The proposed treatment development activities include:
1. Development of a treatment manual, associated fidelity rating forms, and training aids,
2. Pre-testing the treatment manual with bereaved parents, and revision in consultation with treatment development experts,
Conduct a randomized, wait-list control, pilot study of the proposed treatment:
1. Measure treatment-related change in (a) complicated grief symptoms, the primary outcome variable, which will be assessed using the Inventory of Complicated Grief, and, (b) marital adjustment, the secondary outcome measure, to be assessed using the Dyadic Adjustment Scale. These outcomes will be assessed in treatment and control groups at baseline, at treatment conclusion, and at three month follow-up.
2. Test the difference between the treatment and control groups on changes from baseline to three month follow-up on the exploratory outcome variables of PTSD, depression, social and work impairment, and quality of life
3. Estimate effect sizes of these differences in changes in outcomes
Develop a proposal for a randomized controlled trial of the treatment, based on the results of aim 2.

Condition	Intervention	Phase
Bereaved Parents	Behavioral: Dyadic treatment for parental bereavement	Phase I

MedlinePlus related topics: Bereavement

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	Dyadic Therapy Assessment Among Couples Coping With Traumatic Loss of a Child

Further study details as provided by Herzog Hospital:

Primary Outcome Measures:

complicated grief symptoms (ICG) and
marital adjustment. An analysis of change scores is equivalent to a repeated measures analysis comparing only baseline to three-month follow-up.

Estimated Enrollment:	80
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2007

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Parents under the age of 21
Presence of overt psychosis as measured with the SCID
Active substance abuse or dependence as measured with the SCID
Suicidal or homicidal ideation as measured with the SCID and the BSS
Suicidal or homicidal plans within the previous 6 months
Initiation or change in psychotropic medication within the past 3 months
Cognitive impairment precluding informed consent or ability to participate in treatment activities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447174

Contacts

Contact: Danny Brom, Ph.D

+972-2-6449666

Locations

Israel
The Israel Center for the Treatment of Psychotrauma	Recruiting
Jerusalem, Israel
Contact: Danny Brom, Ph.D +972-2-6449666 DBROM@HERZOGHOSPITAL.ORG
Principal Investigator: Danny Brom, Ph.D

Sponsors and Collaborators

Herzog Hospital

Mount Sinai School of Medicine

Investigators

Principal Investigator:

Claude M Chemtob, Ph.D

Mount Sinai Medical School

More Information

Study ID Numbers:	BromD1CTIL
Study First Received:	March 13, 2007
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00447174
Health Authority:	Israel: Ministry of Health

Keywords provided by Herzog Hospital:

Grief
parental bereavement

ClinicalTrials.gov processed this record on January 16, 2009