Mental Disorders Diagnosed in ChildhoodPhase 3NCT01008189
6-Year Follow-up of a Prevention Program for Bereaved Families
A Phase 3 study testing Self- study comparison group and Family Bereavement Program in people with Mental Disorders Diagnosed in Childhood, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders Diagnosed in Childhood
- What is being tested?
- Self- study comparison group and Family Bereavement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Experienced parental death in prior 30 months
- Youth age 8-16 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Research Center Arizona State University
Tempe, Arizona, 85287
About this study
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.
- Conditions
- Mental Disorders Diagnosed in Childhood
- Being tested
- Self- study comparison group, Family Bereavement Program
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self- study comparison groupBehavioural
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 ProgramBehavioural
12 session groups for caregivers and bereaved children and adolescents plus two individual sessions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Self- study comparison group |
| Family Bereavement Program | Experimental | 12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions Receives: Behavioral: Family Bereavement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Interview Schedule for Children (DISC)
Measured: One year
Child Behavior Checklist and Young Adult Behavior Checklist
Measured: one year
Youth Self Report (YSR)and Young Adult Self Report (YASR)
Measured: one year
Secondary outcomes (8)
Monitoring the Future - substance use
Measured: one year
Rosenberg Self-esteem scale
Measured: one year
Beck Depression Inventory for parents
Measured: One week
Social and academic competence
Measured: one year
Grade point average
Measured: one year
Cortisol
Measured: 45 minutes
Parent and child report of parenting
Measured: One year
Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 1996
- Primary completionJul 2005
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental Disorders Diagnosed in ChildhoodStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Irwin N Sandler, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008189
- Sponsor's protocol ID
- R01MH049155
- Other IDs
- R01MH049155
- Status last verified
- Nov 2009
- First submitted
- 24 Sep 2009
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1037/0022-006x.71.3.587.
PubMed 12795581Sandler 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.
PubMed 36898606Danvers 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.
PubMed 32720190Sandler 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.
PubMed 27427807Sandler 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.
PubMed 20921347
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6-Year Follow-up of a Prevention Program for Bereaved Families
- ClinicalTrials.gov ID
- NCT01008189
- Acronym / sponsor ID
- R01MH049155
- Conditions
- Mental Disorders Diagnosed in Childhood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 1996
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self study comparison group | Active comparator | Behavioral: Self- study comparison groupCaregivers 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 | Experimental | Behavioral: Family Bereavement Program12- session group for caregivers and bereaved children and adolescents plus 2 individual sessions |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Experienced parental death in prior 30 months
- Youth age 8-16 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self- study comparison groupCaregivers, children and adolescents each received three books about coping with grief following the death of a loved one plus a syllabus to guide reading | Behavioural | Self study comparison group |
| Family Bereavement Program12 session groups for caregivers and bereaved children and adolescents plus two individual sessions | Behavioural | Family Bereavement Program |
Primary outcome
Diagnostic Interview Schedule for Children (DISC)
Time frame: One year
Child Behavior Checklist and Young Adult Behavior Checklist
Time frame: one year
Youth Self Report (YSR)and Young Adult Self Report (YASR)
Time frame: one year
8 secondary outcomes
Monitoring the Future - substance use
Time frame: one year
Rosenberg Self-esteem scale
Time frame: one year
Beck Depression Inventory for parents
Time frame: One week
Social and academic competence
Time frame: one year
Grade point average
Time frame: one year
Cortisol
Time frame: 45 minutes
Parent and child report of parenting
Time frame: One year
Grief - TRIG, Intrusive Grief Thoughts Scale, Inventory of Complicated Grief
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
- Background: PubMed 12795581Sandler 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.
- Derived from this study: PubMed 36898606Sandler 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.
- Derived from this study: PubMed 32720190Danvers 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.
- Derived from this study: PubMed 27427807Sandler 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.
- Derived from this study: PubMed 20921347Sandler 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irwin N Sandler, Ph.D. principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self- study comparison group and Family Bereavement Program in people with Mental Disorders Diagnosed in Childhood, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Interview Schedule for Children (DISC) (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008189, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2009; AzTrials last refreshed its copy on 6 Nov 2026.