DepressionFDPNCT02021578
A Family Depression Prevention Program
A study testing Family Cognitive Behavioral Prevention and Written information in people with Depression, run by Vanderbilt University at 2 sites in United States.
Trial summary
The primary aim is to prevent depression in youth and parents in a single, integrated family intervention. Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the… Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Depression
- What is being tested?
- Family Cognitive Behavioral Prevention 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
- 2 sitesUnited 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent with a current or history of a depressive disorder within child's life
- Children ages 9- to 15-years-old
Who cannot join
- Bipolar I (parent or child)
- Schizophrenia (parent or child)
- Current alcohol or drug abuse (parent or child)
- Conduct disorder; developmental disability (child)
- Current diagnosis of a depressive disorder (child)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University
Nashville, Tennessee, 37203-5721
San Diego State University
San Diego, California, 92120-4913
About this study
Official title: Family Cognitive Behavioral Prevention of Depression in Youth and Parents
The primary aim is to prevent depression in youth and parents in a single, integrated family intervention.
Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition.
Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.
Read the detailed description
Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This "dual prevention" approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (10 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.
- Conditions
- Depression
- Being tested
- Family Cognitive Behavioral Prevention, Written information
- Keywords
- Depression, Mood disorder
- Medical subject headings
- Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Cognitive Behavioral PreventionBehavioural
Also called Cognitive behavioral intervention, Coping skills training, Parent training
Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
Written informationBehavioural
Also called Psychoeducation, Self-help
Reading materials about depression
| Study group | Role | What they receive |
|---|---|---|
| Family Cognitive Behavioral Prevention | Experimental | A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills. Receives: Behavioral: Family Cognitive Behavioral Prevention |
| Written Information | Active comparator | Families receive written materials about depression and the effects of parental depression on children. Receives: Behavioral: Written information |
What is being measured
The primary outcome is the main question the study is designed to answer.
In children, the primary outcome is level of symptoms on the Youth Self-report form.
For child participants, we will assess change in their levels of symptoms on the Youth Self-report form at 12-month follow-up. T-scores range from 0 to 100; higher scores indicate more symptoms (i.e., worse outcome).
Measured: twelve months post baseline
Secondary outcomes (3)
In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child
For child participants, we will assess change in their levels of symptoms on the Child Behavior checklist at 12-month follow-up.
Measured: 12 months
Parents: Patient Health Questionnaire - 9 (PHQ-9)
Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.
Measured: 12 months
Children: depressive diagnoses
Children and parents are interviewed about the child's depressive symptoms with the Longitudinal Interval Follow-up Evaluation, which yields scores 1-6 for each week.
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 posted27 Dec 2013 (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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Judith Garber, Vanderbilt University
- Investigators
- Judy Garber, PhD, Principal investigator, Vanderbilt UniversityBruce Compas, PhD, Principal investigator, Vanderbilt UniversityRobin Weersing, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021578
- Sponsor's protocol ID
- 8482529
- Acronym
- FDP
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2013
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data reported in publications will be made available to researchers upon request.
Publications
Kado-Walton M, Vreeland A, Henry L, Gruhn M, Compas B, Garber J, Weersing VR. Racial/ethnic differences in parenting behaviors among depressed parents. J Fam Psychol. 2023 Sep;37(6):763-773. doi: 10.1037/fam0001125. Epub 2023 Jun 26.
PubMed 37358525
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Cognitive Behavioral Prevention of Depression in Youth and Parents
- ClinicalTrials.gov ID
- NCT02021578
- Acronym / sponsor ID
- FDP / 8482529
- Conditions
- Depression
- Keywords
- Depression, Mood disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Dec 2013 (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.
The primary aim is to prevent depression in youth and parents in a single, integrated family intervention.
Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition.
Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.
Detailed description
Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This "dual prevention" approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (10 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Cognitive Behavioral Prevention | Experimental | Behavioral: Family Cognitive Behavioral PreventionA family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills. |
| Written Information | Active comparator | Behavioral: Written informationFamilies receive written materials about depression and the effects of parental depression on children. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parent with a current or history of a depressive disorder within child's life
- Children ages 9- to 15-years-old
Key exclusion criteria (5 listed)
- Bipolar I (parent or child)
- Schizophrenia (parent or child)
- Current alcohol or drug abuse (parent or child)
- Conduct disorder; developmental disability (child)
- Current diagnosis of a depressive disorder (child)
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 Cognitive Behavioral PreventionAlso: Cognitive behavioral intervention, Coping skills training, Parent trainingParent training and cognitive behavioral intervention with parents. Coping skills training with children. | Behavioural | Family Cognitive Behavioral Prevention |
| Written informationAlso: Psychoeducation, Self-helpReading materials about depression | Behavioural | Written Information |
Primary outcome
In children, the primary outcome is level of symptoms on the Youth Self-report form.
Time frame: twelve months post baseline
For child participants, we will assess change in their levels of symptoms on the Youth Self-report form at 12-month follow-up. T-scores range from 0 to 100; higher scores indicate more symptoms (i.e., worse outcome).
3 secondary outcomes
In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child
Time frame: 12 months
Parents: Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 12 months
Children: depressive diagnoses
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 1 Feb 2024.
- Background: PubMed 37358525Kado-Walton M, Vreeland A, Henry L, Gruhn M, Compas B, Garber J, Weersing VR. Racial/ethnic differences in parenting behaviors among depressed parents. J Fam Psychol. 2023 Sep;37(6):763-773. doi: 10.1037/fam0001125. Epub 2023 Jun 26.
- Link to PMC10613481Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data reported in publications will be made available to researchers upon request.
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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.
Judy Garber, PhD principal investigator
Vanderbilt University
Bruce Compas, PhD principal investigator
Vanderbilt University
Robin Weersing, PhD principal investigator
San Diego State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Cognitive Behavioral Prevention and Written information in people with Depression, run by Vanderbilt University at 2 sites 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 5 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
In children, the primary outcome is level of symptoms on the Youth Self-report form. (time frame: twelve months post baseline). 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 NCT02021578, 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 1 Feb 2024.