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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

Arizona State University

ClinicalTrials.gov Identifier:

NCT01008189

First received: September 24, 2009

Last updated: November 3, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 24, 2009

Last Updated Date

November 3, 2009

Start Date ^ICMJE

January 1996

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01008189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Mental Disorders Diagnosed in Childhood

Intervention ^ICMJE

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
Behavioral: Family Bereavement Program
12 session groups for caregivers and bereaved children and adolescents plus two individual sessions

Study Arm (s)

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

Intervention: Behavioral: Self- study comparison group
Experimental: Family Bereavement Program
12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions

Intervention: Behavioral: Family Bereavement Program

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

244

Completion Date

July 2009

Primary Completion Date

July 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 16 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01008189

Other Study ID Numbers ^ICMJE

R01 MH49155, R01 MH49155

Has Data Monitoring Committee

Yes

Responsible Party

Irwin Sandler, Arizona State University

Study Sponsor ^ICMJE

Arizona State University

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Irwin N Sandler, Ph.D.

Arizona State University

Information Provided By

Arizona State University

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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