DepressionNCT00183482
Family Cognitive Behavioral Therapy for Preventing Depression in Children
A study testing Family Group Cognitive Behavioral and Written Information in people with Depression, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Family Group Cognitive Behavioral and Written Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to 31 Dec 2023
- Phase
- Interventional
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Families with at least one parent with a history of depression during the life of his or her child
- Families with at least one child between the age of 10 and 15
- Parent or guardian willing to provide informed consent for participating children
Who cannot join
- Parent with bipolar disorder or schizophrenia
- Child with conduct disorder or pervasive developmental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder
This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.
Read the detailed description
Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents.
Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families.
Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction.
- Conditions
- Depression
- Being tested
- Family Group Cognitive Behavioral, Written Information
- Keywords
- Parents, Child, Stress, CBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Group Cognitive BehavioralBehavioural
Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
Written InformationBehavioural
Families are mailed written materials that describe depression and stress in families with a depressed parent.
| Study group | Role | What they receive |
|---|---|---|
| Family Group Cognitive Behavioral | Experimental | The intervention is a family group cognitive behavioral program for families of parents with a history of depression to teach parenting skills to parents and coping skills to children. Receives: Behavioral: Family Group Cognitive Behavioral |
| Written Information | Active comparator | The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children. Receives: Behavioral: Written Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalizing and Externalizing symptoms in children
Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome
Measured: 12 months
Secondary outcomes (4)
Depressive symptoms in parents
Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes
Measured: 12 months
Coping skills of children
Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes
Measured: 12 months
Parenting skills of parents
Parent-child interaction coded
Measured: 12 months
Onset of depressive disorders in children
Interviews
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Aug 2014
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated measures ANCOVA design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Bruce Compas, Vanderbilt University
- Investigators
- Bruce E. Compas, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183482
- Sponsor's protocol ID
- R01MH100258
- Other IDs
- R01MH100258
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2005
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ciriegio AE, Pine AE, Cole DA, McKee LG, Forehand R, Compas BE. Mediators of a randomized controlled trial of a preventive intervention for youth of parents with depressive disorders. J Consult Clin Psychol. 2025 Jan;93(1):1-13. doi: 10.1037/ccp0000928.
PubMed 39786802
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00183482
- Acronym / sponsor ID
- R01MH100258
- Conditions
- Depression
- Keywords
- Parents, Child, Stress, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Sep 2005 (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.
This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.
Detailed description
Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents.
Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families.
Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Repeated measures ANCOVA design.
| Arm | Type | Receives |
|---|---|---|
| Family Group Cognitive Behavioral | Experimental | Behavioral: Family Group Cognitive BehavioralThe intervention is a family group cognitive behavioral program for families of parents with a history of depression to teach parenting skills to parents and coping skills to children. |
| Written Information | Active comparator | Behavioral: Written InformationThe comparison arm involves providing written information about depression and stress to parents with a history of depression and their children. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Families with at least one parent with a history of depression during the life of his or her child
- Families with at least one child between the age of 10 and 15
- Parent or guardian willing to provide informed consent for participating children
Key exclusion criteria (2 listed)
- Parent with bipolar disorder or schizophrenia
- Child with conduct disorder or pervasive developmental disorder
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 |
|---|---|---|
| Family Group Cognitive BehavioralGroups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions | Behavioural | Family Group Cognitive Behavioral |
| Written InformationFamilies are mailed written materials that describe depression and stress in families with a depressed parent. | Behavioural | Written Information |
Primary outcome
Internalizing and Externalizing symptoms in children
Time frame: 12 months
Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome
4 secondary outcomes
Depressive symptoms in parents
Time frame: 12 months
Coping skills of children
Time frame: 12 months
Parenting skills of parents
Time frame: 12 months
Onset of depressive disorders in children
Time frame: 12 months
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 17 Jan 2024.
- Derived from this study: PubMed 39786802Ciriegio AE, Pine AE, Cole DA, McKee LG, Forehand R, Compas BE. Mediators of a randomized controlled trial of a preventive intervention for youth of parents with depressive disorders. J Consult Clin Psychol. 2025 Jan;93(1):1-13. doi: 10.1037/ccp0000928.
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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.
Bruce E. Compas, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Group Cognitive Behavioral and Written Information in people with Depression, run by Vanderbilt 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 3 inclusion and 2 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 17 Jan 2024. 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.
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?
Internalizing and Externalizing symptoms in children (time frame: 12 months). 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 NCT00183482, which also lists 1 linked publication.
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 17 Jan 2024.