DepressionPhase 1NCT00061698
Treatment for Depressed Preadolescent Girls
A Phase 1 study testing Cognitive Behavior Therapy Child Only and CBT plus Parent Training in people with Depression, run by University of Texas at Austin.
Trial summary
This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls. Read more about this study
- Who is it for?
- Ages 9 to 13 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavior Therapy Child Only and CBT plus Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Dec 2008
- 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 9 to 13 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Depressive Disorder
Who cannot join
- Learning disability or limited intellectual ability
- Health-related illness that would prevent the patient from completing the research study
About this study
Official title: CBT vs CBT Plus Parent Training for Girls With Depression
This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.
Read the detailed description
Depressive disorders during childhood are virulent, long-lasting disorders that are a risk factor for the development of future depressive episodes and other psychiatric difficulties. A dysfunctional family environment is a possible pathway to the development of depression in adolescents. The family environment is an especially salient context for the development of depression in preadolescent girls.
Depression is expressed differently between male and female adolescents; girls may not benefit as much as boys from treatments such as cognitive behavioral therapy (CBT) because the treatments may not target disturbances and skills that are specific to preadolescent girls. This study will identify effective treatments for depression in preadolescent girls.
Depressed participants are randomly assigned to receive CBT, CBT plus parent training (PT), or a minimal contact control (MCC). The CBT group receives treatment twice a week for 10 weeks. Participants in the CBT plus PT group receive therapy sessions and group treatment for 10 weeks. Participants in the MCC group meet with a research associate once a week for 10 weeks. During the control visits, the child's depressive symptoms are assessed, but no advice or treatment is given. Participants are assessed at baseline, post-treatment, and at yearly follow-up visits for up to 4 years. School performance, home environment, and the impact of the interventions on parent adjustment are evaluated.
- Conditions
- Depression
- Being tested
- Cognitive Behavior Therapy Child Only, CBT plus Parent Training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy Child OnlyBehavioural
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
CBT plus Parent TrainingBehavioural
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy Child Only | Active comparator | Participants completed 20 sessions of CBT Receives: Behavioral: Cognitive Behavior Therapy Child Only |
| CBT plus Parent training | Active comparator | Child participants completed 20 sessions of CBT and parents completed 8 sessions of parent training Receives: Behavioral: Cognitive Behavior Therapy Child Only; Behavioral: CBT plus Parent Training |
| Minimal Contact Control | No intervention | Participants waited 12 weeks for treatment but their safety and well-being were monitored during this time |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2003 (estimated)
- Study startApr 2002
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061698
- Sponsor's protocol ID
- R01MH063998
- Other IDs
- R01MH063998, DSIR 84-CTS
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2003
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cole DA, Cai L, Martin NC, Findling RL, Youngstrom EA, Garber J, Curry JF, Hyde JS, Essex MJ, Compas BE, Goodyer IM, Rohde P, Stark KD, Slattery MJ, Forehand R. Structure and measurement of depression in youths: applying item response theory to clinical data. Psychol Assess. 2011 Dec;23(4):819-33. doi: 10.1037/a0023518. Epub 2011 May 2.
PubMed 21534696Stark, K. D. (2008). Experiences Implementing the ACTION Treatment Program: Implications for Preventive Interventions. Clinical Psychology: Science and Practice, 15, 342 - 345.
Stapleton LM, Sander JB, Stark KD. Psychometric properties of the Beck Depression Inventory for Youth in a sample of girls. Psychol Assess. 2007 Jun;19(2):230-5. doi: 10.1037/1040-3590.19.2.230.
PubMed 17563204Morey, M. E., Arora, P., & Stark, K. D. (in press). Multiple-Stage Screening of Youth Depression in Schools. Psychology in the Schools.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT vs CBT Plus Parent Training for Girls With Depression
- ClinicalTrials.gov ID
- NCT00061698
- Acronym / sponsor ID
- R01MH063998
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Jun 2003 (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 compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.
Detailed description
Depressive disorders during childhood are virulent, long-lasting disorders that are a risk factor for the development of future depressive episodes and other psychiatric difficulties. A dysfunctional family environment is a possible pathway to the development of depression in adolescents. The family environment is an especially salient context for the development of depression in preadolescent girls.
Depression is expressed differently between male and female adolescents; girls may not benefit as much as boys from treatments such as cognitive behavioral therapy (CBT) because the treatments may not target disturbances and skills that are specific to preadolescent girls. This study will identify effective treatments for depression in preadolescent girls.
Depressed participants are randomly assigned to receive CBT, CBT plus parent training (PT), or a minimal contact control (MCC). The CBT group receives treatment twice a week for 10 weeks. Participants in the CBT plus PT group receive therapy sessions and group treatment for 10 weeks. Participants in the MCC group meet with a research associate once a week for 10 weeks. During the control visits, the child's depressive symptoms are assessed, but no advice or treatment is given. Participants are assessed at baseline, post-treatment, and at yearly follow-up visits for up to 4 years. School performance, home environment, and the impact of the interventions on parent adjustment are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy Child Only | Active comparator | Behavioral: Cognitive Behavior Therapy Child OnlyParticipants completed 20 sessions of CBT |
| CBT plus Parent training | Active comparator | Behavioral: Cognitive Behavior Therapy Child Only, Behavioral: CBT plus Parent TrainingChild participants completed 20 sessions of CBT and parents completed 8 sessions of parent training |
| Minimal Contact Control | No intervention | –Participants waited 12 weeks for treatment but their safety and well-being were monitored during this time |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Depressive Disorder
Key exclusion criteria (2 listed)
- Learning disability or limited intellectual ability
- Health-related illness that would prevent the patient from completing the research study
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 |
|---|---|---|
| Cognitive Behavior Therapy Child OnlyParticipants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. | Behavioural | CBT plus Parent training, Cognitive Behavior Therapy Child Only |
| CBT plus Parent TrainingParticipants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior. | Behavioural | CBT plus Parent training |
Primary outcome
Not reported in the source record.
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 12 Jun 2015.
- Background: PubMed 21534696Cole DA, Cai L, Martin NC, Findling RL, Youngstrom EA, Garber J, Curry JF, Hyde JS, Essex MJ, Compas BE, Goodyer IM, Rohde P, Stark KD, Slattery MJ, Forehand R. Structure and measurement of depression in youths: applying item response theory to clinical data. Psychol Assess. 2011 Dec;23(4):819-33. doi: 10.1037/a0023518. Epub 2011 May 2.
- BackgroundStark, K. D. (2008). Experiences Implementing the ACTION Treatment Program: Implications for Preventive Interventions. Clinical Psychology: Science and Practice, 15, 342 - 345.
- Background: PubMed 17563204Stapleton LM, Sander JB, Stark KD. Psychometric properties of the Beck Depression Inventory for Youth in a sample of girls. Psychol Assess. 2007 Jun;19(2):230-5. doi: 10.1037/1040-3590.19.2.230.
- Results publicationMorey, M. E., Arora, P., & Stark, K. D. (in press). Multiple-Stage Screening of Youth Depression in Schools. Psychology in the Schools.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive Behavior Therapy Child Only and CBT plus Parent Training in people with Depression, run by University of Texas at Austin.
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 1 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 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00061698, which also lists 4 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 12 Jun 2015.