Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01008189
First received: September 24, 2009
Last updated: November 3, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Mental Disorders Diagnosed in Childhood
Behavioral: Self- study comparison group
Behavioral: Family Bereavement Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 6-Year Follow-up of a Prevention Program for Bereaved Families

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Diagnostic Interview Schedule for Children (DISC) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Child Behavior Checklist and Young Adult Behavior Checklist [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Youth Self Report (YSR)and Young Adult Self Report (YASR) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitoring the Future - substance use [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Rosenberg Self-esteem scale [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Beck Depression Inventory for parents [ Time Frame: One week ] [ Designated as safety issue: No ]
  • Social and academic competence [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Grade point average [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Cortisol [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]
  • Parent and child report of parenting [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief [ Time Frame: one month ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: January 1996
Study Completion Date: July 2009
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01008189

Locations
United States, Arizona
Prevention Research Center Arizona State University
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Arizona State University
Investigators
Principal Investigator: Irwin N Sandler, Ph.D. Arizona State University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irwin Sandler, Arizona State University
ClinicalTrials.gov Identifier: NCT01008189     History of Changes
Other Study ID Numbers: R01 MH49155, R01 MH49155
Study First Received: September 24, 2009
Last Updated: November 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mental Disorders
Mental Disorders Diagnosed in Childhood
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 24, 2014