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Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child

NCT00447174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-11-03

No results posted yet for this study

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.

Conditions

  • Bereaved Parents

Interventions

BEHAVIORAL

Dyadic treatment for parental bereavement

Sponsors & Collaborators

Principal Investigators

  • Claude M Chemtob, Ph.D · Mount Sinai Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-01-31
Completion
2012-01-31

Countries

  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447174 on ClinicalTrials.gov