Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child (PBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447174
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : November 3, 2016
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Herzog Hospital

Brief Summary:
  1. 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,
  2. 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
  3. Develop a proposal for a randomized controlled trial of the treatment, based on the results of aim 2.

Condition or disease Intervention/treatment Phase
Bereaved Parents Behavioral: Dyadic treatment for parental bereavement Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dyadic Therapy Assessment Among Couples Coping With Traumatic Loss of a Child
Study Start Date : January 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arm Intervention/treatment
Experimental: treatment
treatment manual
Behavioral: Dyadic treatment for parental bereavement
No Intervention: control group

Primary Outcome Measures :
  1. complicated grief symptom change [ Time Frame: change from pretreatment to 3 month follow-up ]
    Inventory of Complicated Grief

Secondary Outcome Measures :
  1. marital adjustment change [ Time Frame: change from pretreatment to 3 month follow-up ]
    Dyadic Adjustment Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Suffered the loss of a child between the ages of 0 and 25
  • Loss occurred at least 6 months prior to beginning of study
  • Score over 30 on the Inventory of Complicated Grief (ICG)
  • Spouse living with identified patient and scoring less than 30 on the ICG

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447174

The Israel Center for the Treatment of Psychotrauma
Jerusalem, Israel
Sponsors and Collaborators
Herzog Hospital
Icahn School of Medicine at Mount Sinai
Principal Investigator: Claude M Chemtob, Ph.D Mount Sinai Medical School

Responsible Party: Herzog Hospital Identifier: NCT00447174     History of Changes
Other Study ID Numbers: BromD1CTIL
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Herzog Hospital:
parental bereavement