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Completed

NCT Number: NCT01008189

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

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.

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Key information

Conditions

Mental Disorders Diagnosed in Childhood Mental Disorders Neurodevelopmental Disorders

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prevention Research Center Arizona State University

Tempe, Arizona, 85287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self- study comparison group

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

Behavioral

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

Primary outcomes

  1. Diagnostic Interview Schedule for Children (DISC)

    Time frame: One year

  2. Child Behavior Checklist and Young Adult Behavior Checklist

    Time frame: one year

  3. Youth Self Report (YSR)and Young Adult Self Report (YASR)

    Time frame: one year

Secondary outcomes

  1. Monitoring the Future - substance use

    Time frame: one year

  2. Rosenberg Self-esteem scale

    Time frame: one year

  3. Beck Depression Inventory for parents

    Time frame: One week

  4. Social and academic competence

    Time frame: one year

  5. Grade point average

    Time frame: one year

  6. Cortisol

    Time frame: 45 minutes

  7. Parent and child report of parenting

    Time frame: One year

  8. Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
1996
Primary completion
2005
Study completion
2009
First posted
Nov 4, 2009
Registry last updated
Nov 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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