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

This study has been completed.
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00447174
First received: March 13, 2007
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
  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 Intervention
Bereaved Parents
Behavioral: Dyadic treatment for parental bereavement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dyadic Therapy Assessment Among Couples Coping With Traumatic Loss of a Child

Resource links provided by NLM:


Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • complicated grief symptom change [ Time Frame: change from pretreatment to 3 month follow-up ] [ Designated as safety issue: No ]
    Inventory of Complicated Grief


Secondary Outcome Measures:
  • marital adjustment change [ Time Frame: change from pretreatment to 3 month follow-up ] [ Designated as safety issue: No ]
    Dyadic Adjustment Scale


Enrollment: 64
Study Start Date: January 2007
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
treatment manual
Behavioral: Dyadic treatment for parental bereavement
No Intervention: control group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Herzog Hospital
ClinicalTrials.gov Identifier: NCT00447174     History of Changes
Other Study ID Numbers: BromD1CTIL 
Study First Received: March 13, 2007
Last Updated: November 2, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by Herzog Hospital:
Grief
parental bereavement

ClinicalTrials.gov processed this record on December 06, 2016