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

NCT ID: NCT01008189

Last Updated: 2009-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Mental Disorders Diagnosed in Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Self- study comparison group

Intervention Type BEHAVIORAL

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

Family Bereavement Program

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

Group Type EXPERIMENTAL

Family Bereavement Program

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Family Bereavement Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Arizona State University

Principal Investigators

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Irwin N Sandler, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Prevention Research Center Arizona State University

Tempe, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12795581 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36898606 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32720190 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27427807 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20921347 (View on PubMed)

Other Identifiers

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R01MH049155

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH049155

Identifier Type: NIH

Identifier Source: org_study_id

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