DepressionNCT03308864
Strong Connections
A study testing Interpersonal Psychotherapy for Adolescents and Treatment as usual in people with Depression, run by University of Rochester at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal Psychotherapy for Adolescents and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2012to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 12-18
- scoring in the clinically elevated range for depression using the Beck Depression Inventory for Youth
Who cannot join
- currently psychotic
- do not speak English
- currently participating in another form of mental health treatment
- considered to need inpatient hospitalization
- IQ less than 70
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Behavior Health and Wellness
Rochester, New York, 14620
About this study
Official title: Strong Connections-Interpersonal Psychotherapy for Adolescents
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.
- Conditions
- Depression
- Being tested
- Interpersonal Psychotherapy for Adolescents, Treatment as usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for AdolescentsBehavioural
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.
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 5 months
Secondary outcomes (8)
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.
Measured: Baseline to 5 months
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.
Measured: Baseline to 8 months
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.
Measured: Baseline to 5 months
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.
Measured: Baseline to 8 months
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.
Measured: Baseline to 5 months
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.
Measured: Baseline to 8 months
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.
Measured: Baseline to 5 months
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.
Measured: Baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start1 Nov 2012
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Handley, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308864
- Sponsor's protocol ID
- RSRB44140
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Connections-Interpersonal Psychotherapy for Adolescents
- ClinicalTrials.gov ID
- NCT03308864
- Acronym / sponsor ID
- RSRB44140
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy for Adolescents (IPT-A) | Experimental | Behavioral: Interpersonal Psychotherapy for AdolescentsAll adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as usualAll adolescents who present at Child and Adolescent Outpatient Service (CAOS) for a diagnostic intake evaluation and who report any symptoms of depression. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age 12-18
- scoring in the clinically elevated range for depression using the Beck Depression Inventory for Youth
Key exclusion criteria (5 listed)
- currently psychotic
- do not speak English
- currently participating in another form of mental health treatment
- considered to need inpatient hospitalization
- IQ less than 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Psychotherapy for AdolescentsExperimental: 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. | Behavioural | Interpersonal Psychotherapy for Adolescents (IPT-A) |
| Treatment as usualTreatment 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. | Behavioural | Treatment as Usual |
Primary outcome
Change in Mean Beck Depression Inventory score
Time frame: 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.
Change in Mean Beck Depression Inventory score
Time frame: 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.
8 secondary outcomes
Change in the mean score in suicide ideation.
Time frame: Baseline to 5 months
Change in the mean score in suicide ideation.
Time frame: Baseline to 8 months
Change in mean perceived stress
Time frame: Baseline to 5 months
Change in mean perceived stress
Time frame: Baseline to 8 months
Change in mean social adjustment
Time frame: Baseline to 5 months
Change in mean social adjustment
Time frame: Baseline to 8 months
Mean change in social support
Time frame: Baseline to 5 months
Mean change in social support
Time frame: Baseline to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy for Adolescents and Treatment as usual in people with Depression, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Beck Depression Inventory score (time frame: Baseline to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.