DepressionIPTNCT01534377
Interpersonal Psychotherapy for Adolescent Girls
A study testing Interpersonal Psychotherapy for Adolescents and Enhanced Care in people with Depression, run by University of Rochester at 1 site in United States.
Trial summary
This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for the treatment of depression and prevention of depression in maltreated and nonmaltreated girls between the ages of 13-15 years old. Read more about this study
- Who is it for?
- Ages 13 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal Psychotherapy for Adolescents and Enhanced Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2018
- 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 13 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- girls
- ages 13-15 years old
- low SES status
- live in Rochester or surrounding counties
- girls in the maltreated depressive symptom group will have CPS-documented child maltreatment
- girls in the nonmaltreated depressive symptom group will not have CPS- documented child maltreatment
- girls in the nonmaltreated nonsymptomatic comparison group will have no current or past mental illness and no documented child maltreatment
Who cannot join
- taking antidepressants or prescription medications for anxiety
- already receiving mental health treatment
- actively suicidal
- diagnosed with a severe mental disorder
- abusing drugs or alcohol
- evidence of compromised cognitive ability
Show all 9Show fewer
- evidence of a pervasive developmental disorder
- evidence of a major physical or neurological disorder
- non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Depression in Maltreated and Nonmaltreated Adolescents
This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for the treatment of depression and prevention of depression in maltreated and nonmaltreated girls between the ages of 13-15 years old.
Read the detailed description
Child maltreatment poses a serious public health problem and heightens the risk of psychopathology across the life course. Adolescence also represents a peak time for the emergence of depressive disorders particularly in girls. Effective interventions to prevent and treat depression in low income adolescent girls with or without histories of maltreatment are needed.
Three groups will be recruited: Maltreated Depressive Symptoms (MDS), Nonmaltreated Depressive Symptoms (NDS), and a Nonmaltreated Nonsymptomatic Comparison (NNC), comparable in SES, race/ethnicity, and household composition. The MDS and NDS groups will be randomized into IPT-A or Enhanced Care (EC). Adolescent girls in these groups will receive 13 sessions of therapy. Girls in the NNC group will only complete research visits.
Research assessments will be conducted at T1 (baseline/prior to intervention), T2 (6-weeks mid-intervention), T3 (end of intervention), T4 (1-year post) and T5 (18 months post). Girls and their mothers will participate in these research sessions. A multi-level-of-analysis approach, integrating genotyping, hormone assays, cognitive testing, adolescent- and maternal-report, mother-teen observation, and DHS and school records will be utilized to assess the effectiveness of the interventions.
- Conditions
- Depression
- Being tested
- Interpersonal Psychotherapy for Adolescents, Enhanced Care
- Keywords
- Depression, Adolescents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for AdolescentsBehavioural
Also called IPT-A
Adolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context.
Enhanced CareBehavioural
Also called EC
Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression. Receives: Behavioral: Interpersonal Psychotherapy for Adolescents |
| Enhanced Care | Experimental | Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression. Receives: Behavioral: Enhanced Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adolescent depressive symptoms from baseline to post-intervention
To evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for decreasing depressive symptoms and preventing depression in low-income ethnically and culturally diverse adolescent girls with and without histories of child maltreatment
Measured: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2018
- Study completionJun 2018
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.
- More trials run by University of RochesterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sheree Toth, University of Rochester
- Investigators
- Sheree Toth, PhD, Principal investigator, University of RochesterDante Cicchetti, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534377
- Sponsor's protocol ID
- 035457
- Other IDs
- 1R01MH091070-01A1
- Acronym
- IPT
- Status last verified
- Aug 2018
- First submitted
- 2 Feb 2012
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Depression in Maltreated and Nonmaltreated Adolescents
- ClinicalTrials.gov ID
- NCT01534377
- Acronym / sponsor ID
- IPT / 035457
- Conditions
- Depression
- Keywords
- Depression, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2011 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Feb 2012 (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 evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for the treatment of depression and prevention of depression in maltreated and nonmaltreated girls between the ages of 13-15 years old.
Detailed description
Child maltreatment poses a serious public health problem and heightens the risk of psychopathology across the life course. Adolescence also represents a peak time for the emergence of depressive disorders particularly in girls. Effective interventions to prevent and treat depression in low income adolescent girls with or without histories of maltreatment are needed.
Three groups will be recruited: Maltreated Depressive Symptoms (MDS), Nonmaltreated Depressive Symptoms (NDS), and a Nonmaltreated Nonsymptomatic Comparison (NNC), comparable in SES, race/ethnicity, and household composition. The MDS and NDS groups will be randomized into IPT-A or Enhanced Care (EC). Adolescent girls in these groups will receive 13 sessions of therapy. Girls in the NNC group will only complete research visits.
Research assessments will be conducted at T1 (baseline/prior to intervention), T2 (6-weeks mid-intervention), T3 (end of intervention), T4 (1-year post) and T5 (18 months post). Girls and their mothers will participate in these research sessions. A multi-level-of-analysis approach, integrating genotyping, hormone assays, cognitive testing, adolescent- and maternal-report, mother-teen observation, and DHS and school records will be utilized to assess the effectiveness of the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Behavioral: Interpersonal Psychotherapy for AdolescentsAdolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression. |
| Enhanced Care | Experimental | Behavioral: Enhanced CareAdolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- girls
- ages 13-15 years old
- low SES status
- live in Rochester or surrounding counties
- girls in the maltreated depressive symptom group will have CPS-documented child maltreatment
Key exclusion criteria (9 listed)
- taking antidepressants or prescription medications for anxiety
- already receiving mental health treatment
- actively suicidal
- diagnosed with a severe mental disorder
- abusing drugs or alcohol
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 |
|---|---|---|
| Interpersonal Psychotherapy for AdolescentsAlso: IPT-AAdolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context. | Behavioural | Interpersonal Psychotherapy |
| Enhanced CareAlso: ECAdolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression. | Behavioural | Enhanced Care |
Primary outcome
Change in adolescent depressive symptoms from baseline to post-intervention
Time frame: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
To evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for decreasing depressive symptoms and preventing depression in low-income ethnically and culturally diverse adolescent girls with and without histories of child maltreatment
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 3 Aug 2018.
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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.
Sheree Toth, PhD principal investigator
University of Rochester
Dante Cicchetti, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy for Adolescents and Enhanced Care in people with Depression, run by University of Rochester 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 7 inclusion and 9 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 3 Aug 2018. 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?
Change in adolescent depressive symptoms from baseline to post-intervention (time frame: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention). 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 3 Aug 2018.