- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308864
Strong Connections
October 12, 2018 updated by: Elizabeth Handley, University of Rochester
Strong Connections-Interpersonal Psychotherapy for Adolescents
The purpose of this study is to compare two talking forms of therapy designed to help reduce depressive symptoms in teenagers: Interpersonal Psychotherapy for Adolescents and Treatment as Usual.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Interpersonal Psychotherapy for Adolescents (IPT-A) is a manualized short-term therapeutic intervention that has been shown to be efficacious in a number of randomized control trials for adolescent depression.
The primary aim of the present study is to evaluate the feasibility of incorporating Interpersonal Psychotherapy for Adolescents (IPT-A) into routine psychotherapeutic treatment at Strong Behavioral Health: Child and Adolescent Outpatient.
The second aim of the present investigation is to examine changes in adolescent symptomatology, interpersonal functioning, perceived stress, and social support throughout the course of treatment.
The third aim of the present study is to compare the effectiveness of IPT-A versus treatment as usual (TAU) at reducing depressive symptoms among adolescents.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14620
- Pediatric Behavior Health and Wellness
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 12-18
- scoring in the clinically elevated range for depression using the Beck Depression Inventory for Youth
Exclusion Criteria:
- currently psychotic
- do not speak English
- currently participating in another form of mental health treatment
- considered to need inpatient hospitalization
- IQ less than 70
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interpersonal Psychotherapy for Adolescents (IPT-A)
All adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression.
|
Experimental: Interpersonal Psychotherapy for Adolescents (IPT-A) IPT-A is a manualized intervention for depression that targets adolescents' interpersonal context and social supports as mechanisms of change.
It will be provided in accordance with the treatment manual by Child and Adolescent Outpatient Service clinicians over the course of 12-16 50-minute sessions.
|
|
Active Comparator: Treatment as Usual
All adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression.
|
Treatment as usual will consist of the standard care for adolescent depressive symptoms at CAOS.
TAU is not manualized; it is consistent with care typically provided in community settings.
Therapists establish a working alliance, are empathetic, reflect expressed affect, and discuss options for coping with concerns as initiated by the adolescent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Beck Depression Inventory score
Time Frame: Baseline to 8 months
|
Adolescents' depressive symptomatology will be measured using adolescent-report of the Beck Depression Inventory-Youth.
It is a 20-item scale ranging from 0 to 100 with higher scores indicating worse health outcomes.
|
Baseline to 8 months
|
|
Change in Mean Beck Depression Inventory score
Time Frame: Baseline to 5 months
|
Adolescents' depressive symptomatology will be measured using adolescent-report of the Beck Depression Inventory-Youth.
It is a 20-item scale ranging from 0 to 100 with higher scores indicating worse health outcomes.
|
Baseline to 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the mean score in suicide ideation.
Time Frame: Baseline to 5 months
|
The Beck Suicide Scale will be used to measure suicide ideation.
It is a 21-item scale ranging from 0-2 with higher scores higher levels of suicide ideation.
|
Baseline to 5 months
|
|
Change in the mean score in suicide ideation.
Time Frame: Baseline to 8 months
|
The Beck Suicide Scale will be used to measure suicide ideation.
It is a 21-item scale ranging from 0-2 with higher scores higher levels of suicide ideation.
|
Baseline to 8 months
|
|
Change in mean perceived stress
Time Frame: Baseline to 5 months
|
The Perceived Stress Scale will be used to measure perceived stress.
It is a 14-item scale ranging from 0-4 with higher scores higher levels of stress.
|
Baseline to 5 months
|
|
Change in mean perceived stress
Time Frame: Baseline to 8 months
|
The Perceived Stress Scale will be used to measure perceived stress.
It is a 14-item scale ranging from 0-4 with higher scores higher levels of stress.
|
Baseline to 8 months
|
|
Change in mean social adjustment
Time Frame: Baseline to 5 months
|
The Social Adjustment Scale-SR will be used to measure social adjustment.
It is a 23-item scale ranging from 0-5 with higher scores higher levels of social adjustment.
|
Baseline to 5 months
|
|
Change in mean social adjustment
Time Frame: Baseline to 8 months
|
The Social Adjustment Scale-SR will be used to measure social adjustment.
It is a 23-item scale ranging from 0-5 with higher scores higher levels of social adjustment.
|
Baseline to 8 months
|
|
Mean change in social support
Time Frame: Baseline to 5 months
|
The Social Support Behaviors Scale will be used to measure social support.
There are two domains, one for family and one for friends.
It is a 45-item scale ranging from 0-5 with higher scores indicating higher levels of social support.
|
Baseline to 5 months
|
|
Mean change in social support
Time Frame: Baseline to 8 months
|
The Social Support Behaviors Scale will be used to measure social support.
There are two domains, one for family and one for friends.
It is a 45-item scale ranging from 0-5 with higher scores indicating higher levels of social support.
|
Baseline to 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2012
Primary Completion (Actual)
August 22, 2018
Study Completion (Actual)
August 22, 2018
Study Registration Dates
First Submitted
October 9, 2017
First Submitted That Met QC Criteria
October 9, 2017
First Posted (Actual)
October 13, 2017
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSRB44140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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