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Strong Connections

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Adolescents
Treatment as usual
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Behavior Health and Wellness

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy for Adolescents (IPT-A)

Treatment as Usual

Arm Description

All adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression.

All adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression.

Outcomes

Primary Outcome Measures

Change in Mean Beck Depression Inventory score
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.
Change in Mean Beck Depression Inventory score
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.

Secondary Outcome Measures

Change in the mean score in suicide ideation.
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.
Change in the mean score in suicide ideation.
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.
Change in mean perceived stress
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.
Change in mean perceived stress
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.
Change in mean social adjustment
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.
Change in mean social adjustment
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.
Mean change in social support
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.
Mean change in social support
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.

Full Information

First Posted
October 9, 2017
Last Updated
October 12, 2018
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03308864
Brief Title
Strong Connections
Official Title
Strong Connections-Interpersonal Psychotherapy for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy for Adolescents (IPT-A)
Arm Type
Experimental
Arm Description
All adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
All adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Adolescents
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Mean Beck Depression Inventory score
Description
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.
Time Frame
Baseline to 8 months
Title
Change in Mean Beck Depression Inventory score
Description
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.
Time Frame
Baseline to 5 months
Secondary Outcome Measure Information:
Title
Change in the mean score in suicide ideation.
Description
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.
Time Frame
Baseline to 5 months
Title
Change in the mean score in suicide ideation.
Description
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.
Time Frame
Baseline to 8 months
Title
Change in mean perceived stress
Description
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.
Time Frame
Baseline to 5 months
Title
Change in mean perceived stress
Description
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.
Time Frame
Baseline to 8 months
Title
Change in mean social adjustment
Description
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.
Time Frame
Baseline to 5 months
Title
Change in mean social adjustment
Description
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.
Time Frame
Baseline to 8 months
Title
Mean change in social support
Description
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.
Time Frame
Baseline to 5 months
Title
Mean change in social support
Description
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.
Time Frame
Baseline to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pediatric Behavior Health and Wellness
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Strong Connections

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