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

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ClinicalTrials.gov Identifier: NCT01008189
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : November 4, 2009
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Arizona State University

Brief Summary:

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 or disease Intervention/treatment Phase
Mental Disorders Diagnosed in Childhood Behavioral: Self- study comparison group Behavioral: Family Bereavement Program Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 6-Year Follow-up of a Prevention Program for Bereaved Families
Study Start Date : January 1996
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Diagnostic Interview Schedule for Children (DISC) [ Time Frame: One year ]
  2. Child Behavior Checklist and Young Adult Behavior Checklist [ Time Frame: one year ]
  3. Youth Self Report (YSR)and Young Adult Self Report (YASR) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Monitoring the Future - substance use [ Time Frame: one year ]
  2. Rosenberg Self-esteem scale [ Time Frame: one year ]
  3. Beck Depression Inventory for parents [ Time Frame: One week ]
  4. Social and academic competence [ Time Frame: one year ]
  5. Grade point average [ Time Frame: one year ]
  6. Cortisol [ Time Frame: 45 minutes ]
  7. Parent and child report of parenting [ Time Frame: One year ]
  8. Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief [ Time Frame: one month ]


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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008189


Locations
United States, Arizona
Prevention Research Center Arizona State University
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Arizona State University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Irwin N Sandler, Ph.D. Arizona State University