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CompletedNCT03308864Updated Oct 15, 2018

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An interventional study of Interpersonal Psychotherapy for Adolescents and Treatment as usual in Depression, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Depression

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03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralInterpersonal 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.

  • BehavioralTreatment 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 8 months

  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.

    Time frame: Baseline to 5 months

Secondary outcomes

  1. 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.

    Time frame: Baseline to 5 months

  2. 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.

    Time frame: Baseline to 8 months

  3. 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.

    Time frame: Baseline to 5 months

  4. 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.

    Time frame: Baseline to 8 months

  5. 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.

    Time frame: Baseline to 5 months

  6. 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.

    Time frame: Baseline to 8 months

  7. 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.

    Time frame: Baseline to 5 months

  8. 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.

    Time frame: Baseline to 8 months

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Study locations

1 site
  • Pediatric Behavior Health and Wellness
    Rochester, New York 14620, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03308864
Lead sponsor
University of Rochester
Responsible party
Elizabeth Handley (Research Associate, University of Rochester) — Principal investigator
First posted
Oct 13, 2017
Start date
Nov 1, 2012
Primary completion
Aug 22, 2018
Completion
Aug 22, 2018
Last update
Oct 15, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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