An Adaptive Treatment Strategy for Adolescent Depression (PTAD)
The purpose of the study is:
- to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and
- to compare two ways of providing treatment to teenagers who have not improved enough.
This study has three phases:
The screening and eligibility phase:
Parent and child will conduct an initial evaluation that will last about 4 hours. The evaluator will ask questions and the participant will complete forms about his/her mood and behavior. This intake appointment will determine eligibility for the study.
The treatment phase: The child would begin a kind of talk therapy called interpersonal psychotherapy. The goal of the therapy is to decrease teenagers' depression by helping them improve their relationships and communication skills. The child will attend 12 therapy appointments over the course of 16 weeks. Each appointment will be 50 minutes long.
If the child is doing well with standard interpersonal therapy, it will be continued without change. If the child has not improved enough, we will change the treatment plan in one of two ways. The choice will be based on chance (sort of like flipping a coin) and will be done by a computer.
***Your child will attend 16 therapy appointments (that is four additional sessions). These additional four sessions will be scheduled so that your child will attend therapy twice a week for a period of four weeks.
***Your child will continue to attend 12 therapy appointments over the course of 16 weeks and your child will also be prescribed an antidepressant medication called fluoxetine. Fluoxetine is also known as Prozac. Prozac has been approved by the Food and Drug Administration for use in the treatment of depressed teenagers. You will be responsible for paying for the medication.
At four points during the treatment phase (week 4, week 8, week 12, and week 16), parent and child will be asked to complete forms and interviews to see how the child is doing. The evaluations at weeks 4, 8, and 12 will take approximately 1 hour. At the end of treatment, parent and child will have a longer meeting with the evaluator (4 hours) to see if the treatment your child got was helpful. During these meetings, we will also ask participants to fill out some forms about your mood and mental health treatment.
- The follow-up phase: Parent and child will be asked to return for a follow-up assessment 4 months after the child completes the treatment phase to see how he or she is doing. Parent and child will be asked to complete forms and interviews. This meeting will take approximately 4 hours.
Behavioral: Interpersonal Psychotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||An Adaptive Treatment Strategy for Adolescent Depression|
- K-SADS-PL - baseline; change from baseline in KSADS at week 16 and 32 [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]Clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.
- BDI-II-baseline; change from baseline in BDI at weeks 4/8/12/16/32 [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]A self-report measure that assesses the severity of 21 depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week.
- HRSD-baseline; change from baseline in HRSD at weeks 4/8/12/16/32 [ Time Frame: Baseline ] [ Designated as safety issue: No ]A clinician-administered semi-structured interview measure developed to assess the severity of depression symptoms. It was initially designed for use with adults, but is widely used with adolescents, as well. It will also be used by the study clinicians in the first and fourth therapy sessions to guide implementation of the adaptive treatment strategy.
- CSSR-S-baseline; change from baseline in CSSR-S at weeks 4/8/12/16/32 [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]A clinician-administered standardized suicidal rating system that is based on definitions of suicidality derived from empirical findings on the phenomenology of suicidality and identified predictive and risk factors.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Experimental: Interpersonal Psychotherapy||
Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. Sessions will include assessment of vital signs, adverse effects, safety, and symptomatic response. Adolescents will be given enough pills to last until their next scheduled appointment and will be asked to bring back the bottle of pills to each appointment. The psychiatrist will count the number of pills remaining to assess treatment adherence. If patients are tapered from medications, this will occur after the 16 week protocol
Other Name: ProzacBehavioral: Interpersonal Psychotherapy
Adolescent randomized to an increase in therapy (4 extra therapy sessions)
|Contact: Ana Bortnova, BAemail@example.com|
|Contact: Mindy Westlund, BAfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota, Department of Psychiatry||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Meredith Gunlicks-Stoessel, PhD||University of Minnesota - Clinical and Translational Science Institute|