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Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents (IPCAS)

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ClinicalTrials.gov Identifier: NCT03001245
Recruitment Status : Unknown
Verified December 2016 by Dr. Klaus Ranta, Hospital District of Helsinki and Uusimaa.
Recruitment status was:  Recruiting
First Posted : December 22, 2016
Last Update Posted : December 22, 2016
Sponsor:
Collaborators:
Ministry of Social Affairs and Health; Finland
National Institute for Health and Welfare, Finland
City of Espoo
Information provided by (Responsible Party):
Dr. Klaus Ranta, Hospital District of Helsinki and Uusimaa

Brief Summary:

The aim of this cluster randomized trial is to investigate whether the brief, 1+6 session psychosocial intervention, Interpersonal Counseling (IPC) is more effective than standard professional treatment (ST) in the treatment of mild or moderate depression among 12 to 17-year-old adolescents in services provided by school health care and counseling professionals (school nurses, school psychologists and school social workers). The clients are identified from the pool of adolescents routinely seen in school health care and counseling services.

A total of 54 school nurses, social workers, and psychologists from all public secondary schools in the standard education system of City of Espoo, Finland will be trained in IPC in a three-day workshop in two waves. Each school (plus the one primary care level health care unit for adolescents in Espoo) is represented by 1-3 trial IPC counselors. In the first wave the schools are cluster randomized to provide either A) 1+6 sessions of IPC, or B) 1+6 sessions of standard treatment (ST), which consists of psychosocial work as guided by the workers' own standard professional principles and methods. The workers randomized to deliver IPC get the IPC training immediately. In the second wave those who delivered ST in the first wave will be trained in IPC. The data for this trial will be collected from the first wave. The data collection period is one school year plus follow-up of clients after 3 and 6 months.

The clients are adolescents who have either self-referred themselves, are referred by other school personnel, or by parents to the services offered in the school due to emotional symptoms in the school year 2016 -2017 in the participating schools. They are screened with the BDI at the initial visit to identify depressive symptoms. A diagnostic interview will be administered to those exceeding a clinical cutoff. Main inclusion criterion is DSM-5 depressive disorder of either mild or moderate severity. Those with current harmful alcohol use, acute suicidal ideation or behavior, severe depression or anxiety disorder, psychotic symptoms or very low global level of functioning are excluded and offered other treatment.

The clients will complete self-report questionnaires (BDI) as outcome measures. Their level of depression symptoms will also be assessed with ADRS scale and their level of global psychosocial functioning with the CGAS by the project IPC counselors / ST providers. Moreover, the clients will complete the Young Person's Clinical Outcomes for Routine Evaluation (YP-CORE) as a measure of global symptomatology after each session. A follow-up interview at 3 months and 6 months after treatment termination will be arranged. The K-SADS-PL will be used for diagnostic evaluation, the ADRS and the C-GAS to assess level of depressive symptoms and global functioning, and the adolescent completes both the BDI and YP-CORE as self-reports of symptomatology.


Condition or disease Intervention/treatment Phase
Depressive Disorder Behavioral: Interpersonal Counseling Behavioral: Standard treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents: Implementation and Effectiveness Study in School Health Care
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPC
Interpersonal Counseling
Behavioral: Interpersonal Counseling
Interpersonal Counseling 1+6 sessions

Active Comparator: ST
Standard treatment
Behavioral: Standard treatment
Psychosocial treatment 1+6 sessions guided by the professional's standard professional principles and routinely available methods




Primary Outcome Measures :
  1. Change from Baseline in Adolescent Depression Rating Scale after six scheduled treatment sessions [ Time Frame: 6 weeks ]
  2. Change from Baseline in Children's Global Assessment of Functioning after six scheduled treatment sessions [ Time Frame: 6 weeks ]
  3. Change from Baseline in Beck Depression Inventory after six scheduled treatment sessions [ Time Frame: 6 weeks ]
  4. Change from Baseline in Young Person's Clinical Outcomes for Routine Evaluation after six scheduled treatment sessions [ Time Frame: one, two, three, four, five, and six weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in diagnostic status regarding depressive disorder assessed with Kiddie-Sads-Present and Lifetime Version 3 months after treatment termination [ Time Frame: 3 months after treatment termination ]
  2. Change from Baseline in diagnostic status regarding depressive disorder assessed with Kiddie-Sads-Present and Lifetime Version 6 months after treatment termination [ Time Frame: 6 months after treatment termination ]
  3. Change from Baseline in Adolescent Depression Rating Scale 3 months after treatment termination [ Time Frame: 3 months after treatment termination ]
  4. Change from Baseline in Adolescent Depression Rating Scale 6 months after treatment termination [ Time Frame: 6 months after treatment termination ]
  5. Change from Baseline in Beck Depression Inventory 3 months after treatment termination [ Time Frame: 3 months after treatment termination ]
  6. Change from Baseline in Beck Depression Inventory 6 months after treatment termination [ Time Frame: 6 months after treatment termination ]
  7. Change from Baseline in Children's Global Assessment Scale 3 months after treatment termination [ Time Frame: 3 months after treatment termination ]
  8. Change from Baseline in Children's Global Assessment Scale 6 months after treatment termination [ Time Frame: 6 months after treatment termination ]
  9. Change from Baseline in Young Person's Clinical Outcomes for Routine Evaluation 3 months after treatment termination [ Time Frame: 3 months after treatment termination ]
  10. Change from Baseline in Young Person's Clinical Outcomes for Routine Evaluation 6 months after treatment termination [ Time Frame: 6 months after treatment termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of DSM-5 Depressive Disorder (severity mild or moderate)

Exclusion Criteria:

  • current harmful alcohol use
  • acute suicidal ideation or behavior
  • severe depressive disorder
  • severe anxiety disorder
  • psychotic symptoms
  • very low global level of functioning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001245


Contacts
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Contact: Klaus Y Ranta, M.D., Ph.D. +358-50-4284185 klaus.ranta@hus.fi

Locations
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Finland
Department of Adolescent Psychiatry, Helsinki University Central Hospital Recruiting
Helsinki, Finland, P. O.Box 590, FI-00029
Contact: Klaus Y Ranta, M.D., Ph.D.    +358-44-4284185    klaus.ranta@hus.fi   
Contact: Tarja Dorsch, Secretary       tarja.dorsch@hus.fi   
Sponsors and Collaborators
Hospital District of Helsinki and Uusimaa
Ministry of Social Affairs and Health; Finland
National Institute for Health and Welfare, Finland
City of Espoo
Investigators
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Study Chair: Klaus Y Ranta, M.D., Ph.D. Hospital District of Helsinki and Uusimaa, Helsinki University Central Hospital
Study Director: Mauri Marttunen, M.D., Ph.D. University of Helsinki, Department of Adolesecent Psychiatry

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Responsible Party: Dr. Klaus Ranta, Head of Department, Department of Adolescent Psychiatry, Helsinki University Central Hospital, Hospital District of Helsinki and Uusimaa
ClinicalTrials.gov Identifier: NCT03001245     History of Changes
Other Study ID Numbers: HUS 1277/2016
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Klaus Ranta, Hospital District of Helsinki and Uusimaa:
adolescents
depression
psychotherapy
interpersonal therapy

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders