6-Year Follow-up of a Prevention Program for Bereaved Families

November 3, 2009 updated by: Arizona State University

Six-years following participation in the Family Bereavement Program (FBP) participants in the program as compared to a self-study control group will have lower levels of mental health problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower use of substances, higher levels of competence at achieving developmentally appropriate tasks in academic achievement and social competence, and better self-esteem. The effects of the FBP will be moderated by baseline levels of mental health problems and gender. Bereaved caregivers who participated in the program will also show lower levels of mental health problems as compared with controls.

Program effects will be mediated by theoretical mediators targeted by the program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85287
        • Prevention Research Center Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Experienced parental death in prior 30 months
  • Youth age 8-16 years old

Exclusion Criteria:

  • Not currently in other treatment for mental health problems
  • Caregiver not meet criteria for clinical depression
  • Youth not meet criteria for externalizing problems
  • Not currently suicidal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self study comparison group
Caregivers and children and adolescents each received three books about coping with grief after the death of a loved one and a syllabus to guide reading
Behavioral: Self- study comparison group
Caregivers, children and adolescents each received three books about coping with grief following the death of a loved one plus a syllabus to guide reading
Experimental: Family Bereavement Program
12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions
Behavioral: Family Bereavement Program
12 session groups for caregivers and bereaved children and adolescents plus two individual sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic Interview Schedule for Children (DISC)
Time Frame: One year
One year
Child Behavior Checklist and Young Adult Behavior Checklist
Time Frame: one year
one year
Youth Self Report (YSR)and Young Adult Self Report (YASR)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Monitoring the Future - substance use
Time Frame: one year
one year
Rosenberg Self-esteem scale
Time Frame: one year
one year
Beck Depression Inventory for parents
Time Frame: One week
One week
Social and academic competence
Time Frame: one year
one year
Grade point average
Time Frame: one year
one year
Cortisol
Time Frame: 45 minutes
45 minutes
Parent and child report of parenting
Time Frame: One year
One year
Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Irwin N Sandler, Ph.D., Arizona State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2009

Last Update Submitted That Met QC Criteria

November 3, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH049155 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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