Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child

NCT00447174 | Completed DMC

• 1 other identifier: BromD1CTIL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Develop a treatment for clinically significant parental bereavement. The proposed treatment development activities include:
2. 2.Development of a treatment manual, associated fidelity rating forms, and training aids,
3. 3.Pre-testing the treatment manual with bereaved parents, and revision in consultation with treatment development experts,
4. 4.Conduct a randomized, wait-list control, pilot study of the proposed treatment:
5. 5.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.
6. 6.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
7. 7.Estimate effect sizes of these differences in changes in outcomes
8. 8.Develop a proposal for a randomized controlled trial of the treatment, based on the results of aim 2.

Conditions

Bereaved Parents

Keywords

Grief; parental bereavement

Outcome Measures

Primary Outcomes (1)

• complicated grief symptom change

  Inventory of Complicated Grief

  change from pretreatment to 3 month follow-up

Secondary Outcomes (1)

• marital adjustment change

  change from pretreatment to 3 month follow-up

Study Arms (2)

treatment

EXPERIMENTAL

treatment manual

Behavioral: Dyadic treatment for parental bereavement

control group

NO INTERVENTION

Interventions

Dyadic treatment for parental bereavement BEHAVIORAL

treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herzog Hospital: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

The Israel Center for the Treatment of Psychotrauma

Jerusalem, Israel

Location

Study Officials

• Claude M Chemtob, Ph.D

  Mount Sinai Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

IL (1)