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

Phase 3

Completed

• Conditions: Mental Disorders Diagnosed in Childhood
• Interventions: Behavioral: Self- study comparison group; Behavioral: Family Bereavement Program

• Registration Number: NCT01008189
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-01
• Primary Completion: 2005-07
• Study Completion: 2009-07
• Study First Submitted: 2009-09-24
• Status Verified: 2009-11
• Study First Submitted QC: 2009-11-03
• Last Update Submitted: 2009-11-03
• Study First Posted: 2009-11-04
• Last Update Posted: 2009-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic Interview Schedule for Children (DISC)	One year
Child Behavior Checklist and Young Adult Behavior Checklist	one year
Youth Self Report (YSR)and Young Adult Self Report (YASR)	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prevention Research Center Arizona State University; 🇺🇸 Tempe, Arizona, United States