NCT01008189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
Last Updated

November 4, 2009

Status Verified

November 1, 2009

Enrollment Period

9.5 years

First QC Date

September 24, 2009

Last Update Submit

November 3, 2009

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Monitoring the Future - substance use

    one year

  • Rosenberg Self-esteem scale

    one year

  • Beck Depression Inventory for parents

    One week

  • Social and academic competence

    one year

  • Grade point average

    one year

  • +3 more secondary outcomes

Study Arms (2)

Self study comparison group

ACTIVE COMPARATOR

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

Family Bereavement Program

EXPERIMENTAL

12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions

Behavioral: Family Bereavement Program

Interventions

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

Self study comparison group

12 session groups for caregivers and bereaved children and adolescents plus two individual sessions

Family Bereavement Program

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Experienced parental death in prior 30 months
  • Youth age 8-16 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention Research Center Arizona State University

Tempe, Arizona, 85287, United States

Location

Related Publications (5)

  • 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. doi: 10.1037/0022-006x.71.3.587.

    PMID: 12795581BACKGROUND
  • Sandler I, Tein JY, Zhang N, Wolchik SA. Developmental Pathways of the Family Bereavement Program to Prevent Major Depression 15 Years Later. J Am Acad Child Adolesc Psychiatry. 2023 Nov;62(11):1233-1244. doi: 10.1016/j.jaac.2023.02.012. Epub 2023 Mar 8.

  • Danvers AF, Scott BG, Shiota MN, Tein JY, Wolchik SA, Sandler II. Effects of Therapeutic Intervention on Parentally Bereaved Children's Emotion Reactivity and Regulation 15 Years Later. Prev Sci. 2020 Nov;21(8):1017-1027. doi: 10.1007/s11121-020-01142-2.

  • Sandler I, Tein JY, Cham H, Wolchik S, Ayers T. Long-term effects of the Family Bereavement Program on spousally bereaved parents: Grief, mental health problems, alcohol problems, and coping efficacy. Dev Psychopathol. 2016 Aug;28(3):801-18. doi: 10.1017/S0954579416000328.

  • 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. doi: 10.1001/archpediatrics.2010.173.

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Irwin N Sandler, Ph.D.

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2009

First Posted

November 4, 2009

Study Start

January 1, 1996

Primary Completion

July 1, 2005

Study Completion

July 1, 2009

Last Updated

November 4, 2009

Record last verified: 2009-11

Locations