NCT03308864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

5.8 years

First QC Date

October 9, 2017

Last Update Submit

October 12, 2018

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline to 8 months

  • 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.

    Baseline to 5 months

Secondary Outcomes (8)

  • Change in the mean score in suicide ideation.

    Baseline to 5 months

  • Change in the mean score in suicide ideation.

    Baseline to 8 months

  • Change in mean perceived stress

    Baseline to 5 months

  • Change in mean perceived stress

    Baseline to 8 months

  • Change in mean social adjustment

    Baseline to 5 months

  • +3 more secondary outcomes

Study Arms (2)

Interpersonal Psychotherapy for Adolescents (IPT-A)

EXPERIMENTAL

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

Behavioral: Interpersonal Psychotherapy for Adolescents

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Interventions

Interpersonal Psychotherapy for AdolescentsBEHAVIORAL

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.

Interpersonal Psychotherapy for Adolescents (IPT-A)
Treatment as usualBEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 12-18
  • scoring in the clinically elevated range for depression using the Beck Depression Inventory for Youth

You may not qualify if:

  • currently psychotic
  • do not speak English
  • currently participating in another form of mental health treatment
  • considered to need inpatient hospitalization
  • IQ less than 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Behavior Health and Wellness

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Interpersonal PsychotherapyTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

November 1, 2012

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)