DepressionPhase 1NCT01267773
Treatment of Conduct Problems and Depression
A Phase 1 study testing Integrated Treatment in people with Depression and Oppositional Defiant Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Depression, Oppositional Defiant Disorder, Conduct Disorder
- What is being tested?
- Integrated Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2013
- Phase
- Phase 1
- 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 14 years
- All sexes
- Child
Who may be able to join
- 8-14 years old
- Diagnosis of ODD or CD
- Diagnosis of Depression
- Speaks English
Who cannot join
- Developmental/cognitive delays
- Substance dependence
- Psychotic disorder or symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Jennifer C Wolff, PhD, 401-444-3790, jwolff2@lifespan.org
About this study
Official title: Treatment of Youth Comorbid Conduct Problems and Depression
Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be administered over the course of six months. Youth with comorbid conduct problems and depression will be assigned to the experimental condition or treatment as usual in a community care setting. The treatment manual will be revised as needed. Youth will be assessed before and after treatment to examine program potential. The goal of this research is to develop a more comprehensive outpatient treatment for youth with both conduct problems and depression.
- Conditions
- Depression, Oppositional Defiant Disorder, Conduct Disorder
- Being tested
- Integrated Treatment
- Keywords
- depression, conduct problems
- Medical subject headings
- Depression, Oppositional Defiant Disorder, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated TreatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sequential Treatment | Active comparator | Not described Receives: Behavioral: Integrated Treatment |
| Integrated Treatment | Experimental | Not described Receives: Behavioral: Integrated Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms
Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory
Measured: baseline to week 24
oppositional symptoms
change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Jennifer Wolff, Rhode Island Hospital
- Investigators
- Jennifer C Wolff, PhD, Principal investigator, Rhode Island Hospital/Brown UniversityAnthony Spirito, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267773
- Sponsor's protocol ID
- MH086606
- Status last verified
- Mar 2013
- First submitted
- 16 Nov 2010
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Youth Comorbid Conduct Problems and Depression
- ClinicalTrials.gov ID
- NCT01267773
- Acronym / sponsor ID
- MH086606
- Conditions
- Depression, Oppositional Defiant Disorder, Conduct Disorder
- Keywords
- depression, conduct problems
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Aug 2010
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 29 Dec 2010 (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.
Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be administered over the course of six months. Youth with comorbid conduct problems and depression will be assigned to the experimental condition or treatment as usual in a community care setting. The treatment manual will be revised as needed. Youth will be assessed before and after treatment to examine program potential. The goal of this research is to develop a more comprehensive outpatient treatment for youth with both conduct problems and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Treatment | Active comparator | Behavioral: Integrated Treatment |
| Integrated Treatment | Experimental | Behavioral: Integrated Treatment |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8-14 years old
- Diagnosis of ODD or CD
- Diagnosis of Depression
- Speaks English
Key exclusion criteria (3 listed)
- Developmental/cognitive delays
- Substance dependence
- Psychotic disorder or symptoms
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 |
|---|---|---|
| Integrated Treatment | Behavioural | Integrated Treatment, Sequential Treatment |
Primary outcome
Depression Symptoms
Time frame: baseline to week 24
Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory
oppositional symptoms
Time frame: baseline to week 24
change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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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.
Jennifer C Wolff, PhD principal investigator
Rhode Island Hospital/Brown University
Anthony Spirito, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Integrated Treatment in people with Depression and Oppositional Defiant Disorder, run by Rhode Island Hospital 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer C Wolff, PhD (4014443790, jwolff2@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptoms (time frame: baseline to week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2013.