Major DepressionPhase 1NCT00619411
Interpersonal Psychotherapy for Depressed Adolescents and Parents
A Phase 1 study testing Interpersonal Therapy for Depressed Adolescents & Parents in people with Major Depression and Dysthymic Disorder, run by New York State Psychiatric Institute.
Trial summary
The purpose of this study is to examine the feasibility and acceptability of an adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more structured involvement of the parents in the treatment. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Major Depression, Dysthymic Disorder, Adjustment Disorders
- What is being tested?
- Interpersonal Therapy for Depressed Adolescents & Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to May 2009
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
- Score between 10 and 28 on the HRSD
- Score of 65 or less on the C-GAS
- English-speaking adolescent
- Parental or legal guardian consent to participate
Who cannot join
- Actively suicidal
- Score greater than 28 on the HRSD
- Mentally retarded
- Meets diagnostic criteria for current substance abuse, schizophrenia, bipolar disorder, psychosis, conduct disorder, or eating disorder
- Currently in active treatment for depression
- Taking antidepressant medication at the time of baseline assessment
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- Medical illness likely to complicate or interfere with treatment
- Victim of ongoing or previously undisclosed child abuse
- Parent psychiatrically hospitalized within the past 3 months
About this study
Official title: An Open Clinical Trial of Interpersonal Psychotherapy for Depressed Adolescence and Parents
The purpose of this study is to examine the feasibility and acceptability of an adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more structured involvement of the parents in the treatment.
Read the detailed description
Adolescent depression is a significant public health problem, and it increases the risk of poor psychosocial outcomes in adolescence and adulthood. Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) has been found to be an effective treatment for reducing adolescents' depressive symptoms and improving their global and social functioning. The purpose of the current study is to examine the feasibility and acceptability of IPT-A when it is delivered with greater and more structured involvement of the parents in the treatment.
Participants will receive 15 weeks of Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP). Eight the therapy sessions are conducted with the adolescent individually, two are with the parent(s) individually, and five are conducted with the adolescent and parent(s) together. At the end of the 15 weeks, participants who have demonstrated at least a 50% reduction in depressive symptoms will participate in three booster sessions delivered on a monthly basis. All participants will be assessed at baseline, week 5, week 10, week 15 (post-treatment), and 3 months post-treatment to measure depressive symptoms, global and social functioning, and attitudes toward treatment.
- Conditions
- Major Depression, Dysthymic Disorder, Adjustment Disorders, Depressive Disorder Not Otherwise Specified
- Being tested
- Interpersonal Therapy for Depressed Adolescents & Parents
- Keywords
- Major Depression, Dysthymic Disorder, Adjustment Disorder, With Depressed Mood, Depressive, Disorder Not, Otherwise, Specified, Adolescent, Psychotherapy
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Therapy for Depressed Adolescents & ParentsBehavioural
15 weekly psychotherapy sessions
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Behavioral: Interpersonal Therapy for Depressed Adolescents & Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D)
Measured: baseline, week 5, 10, 15
Secondary outcomes (1)
Global Assessment Scale for Children (C-GAS), Social Adjustment Scale - Self-report (SAS-SR), Conflict Behavior Questionnaire (CBQ-20), Observational assessment of parent-adolescent communication
Measured: baseline, week 5, 10, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Meredith Gunlicks-Stoessel, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619411
- Sponsor's protocol ID
- 5549
- Status last verified
- Mar 2012
- First submitted
- 11 Feb 2008
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Trial of Interpersonal Psychotherapy for Depressed Adolescence and Parents
- ClinicalTrials.gov ID
- NCT00619411
- Acronym / sponsor ID
- 5549
- Conditions
- Major Depression, Dysthymic Disorder, Adjustment Disorders, Depressive Disorder Not Otherwise Specified
- Keywords
- Major Depression, Dysthymic Disorder, Adjustment Disorder, With Depressed Mood, Depressive, Disorder Not, Otherwise, Specified
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Feb 2008 (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 purpose of this study is to examine the feasibility and acceptability of an adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more structured involvement of the parents in the treatment.
Detailed description
Adolescent depression is a significant public health problem, and it increases the risk of poor psychosocial outcomes in adolescence and adulthood. Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) has been found to be an effective treatment for reducing adolescents' depressive symptoms and improving their global and social functioning. The purpose of the current study is to examine the feasibility and acceptability of IPT-A when it is delivered with greater and more structured involvement of the parents in the treatment.
Participants will receive 15 weeks of Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP). Eight the therapy sessions are conducted with the adolescent individually, two are with the parent(s) individually, and five are conducted with the adolescent and parent(s) together. At the end of the 15 weeks, participants who have demonstrated at least a 50% reduction in depressive symptoms will participate in three booster sessions delivered on a monthly basis. All participants will be assessed at baseline, week 5, week 10, week 15 (post-treatment), and 3 months post-treatment to measure depressive symptoms, global and social functioning, and attitudes toward treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Interpersonal Therapy for Depressed Adolescents & Parents |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
- Score between 10 and 28 on the HRSD
- Score of 65 or less on the C-GAS
- English-speaking adolescent
- Parental or legal guardian consent to participate
Key exclusion criteria (9 listed)
- Actively suicidal
- Score greater than 28 on the HRSD
- Mentally retarded
- Meets diagnostic criteria for current substance abuse, schizophrenia, bipolar disorder, psychosis, conduct disorder, or eating disorder
- Currently in active treatment for depression
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 Therapy for Depressed Adolescents & Parents15 weekly psychotherapy sessions | Behavioural | I |
Primary outcome
Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D)
Time frame: baseline, week 5, 10, 15
1 secondary outcome
Global Assessment Scale for Children (C-GAS), Social Adjustment Scale - Self-report (SAS-SR), Conflict Behavior Questionnaire (CBQ-20), Observational assessment of parent-adolescent communication
Time frame: baseline, week 5, 10, 15
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 9 Mar 2012.
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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.
Meredith Gunlicks-Stoessel, Ph.D. principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interpersonal Therapy for Depressed Adolescents & Parents in people with Major Depression and Dysthymic Disorder, run by New York State Psychiatric Institute.
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 5 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 9 Mar 2012. 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.
What does the primary outcome measure?
Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D) (time frame: baseline, week 5, 10, 15). 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 9 Mar 2012.