Strong Connections

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT03308864
Collaborator
(none)
34
1
2
69.7
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Interpersonal Psychotherapy for Adolescents
  • Behavioral: Treatment as usual
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Strong Connections-Interpersonal Psychotherapy for Adolescents
Actual Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Aug 22, 2018
Actual Study Completion Date :
Aug 22, 2018

Arms and Interventions

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.

Behavioral: Interpersonal Psychotherapy for Adolescents
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.

Behavioral: Treatment as usual
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Mean Beck Depression Inventory score [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.

  2. Change in Mean Beck Depression Inventory score [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.

Secondary Outcome Measures

  1. Change in the mean score in suicide ideation. [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.

  2. Change in the mean score in suicide ideation. [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.

  3. Change in mean perceived stress [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.

  4. Change in mean perceived stress [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.

  5. Change in mean social adjustment [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.

  6. Change in mean social adjustment [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.

  7. Mean change in social support [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.

  8. Mean change in social support [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pediatric Behavior Health and Wellness Rochester New York United States 14620

Sponsors and Collaborators

  • University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth Handley, Research Associate, University of Rochester
ClinicalTrials.gov Identifier:
NCT03308864
Other Study ID Numbers:
  • RSRB44140
First Posted:
Oct 13, 2017
Last Update Posted:
Oct 15, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2018