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

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:

MedlinePlus related topics: Bereavement Caregivers Child Mental Health Mental Disorders Mental Health Psychotic Disorders

U.S. FDA Resources

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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Irwin N Sandler, Ph.D.

Arizona State University

More Information

Publications:

Sandler IN, Ayers TS, Wolchik SA, Tein JY, Kwok OM, Haine RA, Twohey-Jacobs J, Suter J, Lin K, Padgett-Jones S, Weyer JL, Cole E, Kriege G, Griffin WA. The family bereavement program: efficacy evaluation of a theory-based prevention program for parentally bereaved children and adolescents. J Consult Clin Psychol. 2003 Jun;71(3):587-600.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sandler I, Ayers TS, Tein JY, Wolchik S, Millsap R, Khoo ST, Kaplan D, Ma Y, Luecken L, Schoenfelder E, Coxe S. Six-year follow-up of a preventive intervention for parentally bereaved youths: a randomized controlled trial. Arch Pediatr Adolesc Med. 2010 Oct;164(10):907-14.

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
Psychotic Disorders
Mental Disorders Diagnosed in Childhood
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 22, 2013