PTSDNCT03795818

IPT-A for Adolescents With PTSD Symptoms

A study testing Interpersonal Psychotherapy for Adolescents in people with PTSD, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 18 years
Conditions the study is for: PTSD
What is being tested?: Interpersonal Psychotherapy for Adolescents
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2019to 12 Jun 2023
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 13 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Adolescents who meet criteria for DSM-5 diagnosis of PTSD or have elevated PTSD symptoms
English speaking adolescent and parent
Males and Females ages 13-18 years
Mild to moderate impairment in functioning

Who cannot join

Severe impairment in functioning
Diagnoses of substance abuse, Schizophrenia, Bipolar Disorder, Conduct Disorder, primary eating disorder, psychotic symptoms
Engagement in significant self-injurious behavior in the past 3 months
Active suicidality - presence of plan and/or intent
Intellectual disability or severe learning disability
Medical illness that may interfere with treatment

Show all 9Show fewer

Current physical or sexual abuse
Open Administration for Children's Services (ACS) case
Currently receiving treatment for depression and/or PTSD or have begun a medication trial for another diagnosis within the previous three months

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Official title: An Open Clinical Trial of Interpersonal Psychotherapy for Adolescents With PTSD Symptoms

In the present study, the investigators propose to 1) adapt Interpersonal Psychotherapy for Adolescents (IPT-A) as an intervention for adolescents who report elevated symptoms of posttraumatic stress disorder (PTSD) and/or meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD; and 2) conduct a small open pilot study of IPT-A for PTSD. Ten adolescents ages 13 to 18 who meet DSM-5 criteria for a PTSD diagnosis or have elevated symptoms of PTSD (Child PTSD Symptom Scale [CPSS-5] ≥ 31) will be treated with 14-16 weeks of an adapted version of IPT-A. If participants have evidenced a decrease in PTSD symptoms (CPSS-5 < 31) they will also receive 3 months of once a month maintenance treatment and be assessed by a clinician evaluator at the conclusion of the 3 monthly sessions. If participants have not evidenced a decrease in PTSD symptoms (CPSS-5 ≥ 31), they will be referred for alternative treatments in the community and be assessed by a clinician evaluator 3 months following the completion of IPT-A. All evaluations and therapy sessions will be done over telehealth platform until able to be done in person.

Read the detailed description

Please see the brief summary for study description.

Conditions: PTSD
Being tested: Interpersonal Psychotherapy for Adolescents
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interpersonal Psychotherapy for AdolescentsBehavioural
Also called IPT-A
IPT-A is a psychosocial intervention for adolescents that focuses on improving interpersonal relationships that seem to be associated with the psychiatric symptoms.

Study groups in NCT03795818
Study group	Role	What they receive
IPT-A	Other	Interpersonal psychotherapy for adolescents (IPT-A) is a psychosocial treatment for adolescents. It has been shown to be effective for adolescents with depression. It is now being studied as to its benefit for adolescents who meet criteria for PTSD or have subthreshold PTSD symptoms. Receives: Behavioral: Interpersonal Psychotherapy for Adolescents

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Child PTSD Symptom Scale (CPSS-5)
The Child Post-Traumatic Stress Disorder (PTSD) Symptom Scale (CPSS-5) is a self-report scale designed to assess PTSD symptoms in children and adolescents ages 8-18. The measure screens for stressful life events and asks about the emotional impact of these events in the 4 weeks prior to the assessment. Items are rated on a 5-point scale from 0 (not at all) to 4 (almost always) for how often the problem bothers the youth in the prior 4 weeks. A total symptom severity rating is calculated by summing the ratings of all 20 items and ranges from 0-80, with a higher score indicating greater symptom severity. The CPSS-5 will be used to assess change in PTSD symptoms through study completion at the 3-month follow-up assessment. The scale will be completed at baseline about the prior 4 weeks, at week 7 about the prior 4 weeks, between weeks 14-16 (post-intervention) about the prior 4 weeks, and at the 3-month follow-up assessment about the prior 4 weeks.
Measured: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.
Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5)
The Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DMS-5) - Child/Adolescent Version (CAPS-CA-5) is a 30-item scale that assesses PTSD in children and adolescents ages 7 and older based on the 20 DSM-5 PTSD symptoms. Each item is given a severity rating based on symptom frequency and intensity. Ratings are given for the 4 weeks prior to each assessment timepoint. A total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms and ranges from 0-80, with a higher score indicating greater symptom severity. The CAPS-CA-5 will be used to assess change in symptoms through study completion at the 3-month follow-up assessment. The measure will be administered at baseline rating the prior 4 weeks, between weeks 14-16 (post-intervention) rating the prior 4 weeks, and at the 3-month follow-up assessment rating the prior 4 weeks.
Measured: baseline, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.
Change in Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S)
The Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S) is a 2-item clinician-rated instrument that assesses change in global illness severity and global improvement from baseline prior to treatment to study completion at the 3-month follow-up assessment. The improvement item is scored on a 7-point scale and ranges from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). The severity item is scored on a 7-point scale and ranges from 1 (normal) to 7 (among the most extremely ill patients). It will be administered at baseline rating the prior 2 weeks, at week 7 rating the prior 2 weeks, between weeks 14-16 (post-intervention) rating the prior 2 weeks, and at the 3-month follow-up assessment rating the prior 2 weeks.
Measured: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date

Secondary outcomes (5)

Change in Mood and Feelings Questionnaire (MFQ)
The Mood and Feelings Questionnaire (MFQ) is a 33-item self-report measure completed by the parent and adolescent to identify symptoms of depression in children and adolescents ages 6-17. Items are scored from 0 (not true) to 2 (true). A total score is calculated by summing the point values of all items and ranges from 0 to 66, with higher scores indicating more severe depressive symptoms. The measure will be completed at baseline about the prior 2 weeks, at week 7 about the prior 2 weeks, between weeks 14-16 (post-intervention) about the prior 2 weeks, and at the 3-month follow-up assessment about the prior 2 weeks. Scores at these timepoints will enable assessment of change in symptoms through completion of the study at the 3-month follow-up assessment.
Measured: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date
Change in Social Adjustment Scale-Self Report (SAS-SR)
The Social Adjustment Scale-Self Report (SAS-SR) is a 23-item scale that assesses social adjustment/functioning for the past 2 weeks in 5 areas: overall adjustment, school behavior, relationships with friends, relationships with family, and dating. Items are scored on a Likert scale from 1 to 5. A total score is calculated by averaging all items. Subscale scores are calculated by averaging all items within each subscale. The total and subscale scores range from 1-5, with higher scores indicating more impaired social adjustment. The SAS-SR will be completed at baseline about the prior 2 weeks, at week 7 about the prior 2 weeks, between weeks 14-16 (post-intervention) about the prior 2 weeks, and at the 3-month follow-up assessment about the prior 2 weeks. Ratings will provide information regarding change in social adjustment through study completion at the 3-month follow-up assessment.
Measured: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered measure that collects information on suicidal behavior, suicide attempts, and presence and intensity of suicidal ideation. The majority of the items are scored as yes or no for being present, severity items for suicidal ideation are scored regarding frequency and intensity. A numerical Suicidal Ideation Score is equivalent to the maximum category of items 1-5 that is present at the assessment, where 0 is no suicidal ideation and 5 is active suicidal ideation with specific plan or intent. The baseline version will assess lifetime of the adolescent and past 4 weeks of suicidal ideation and behavior. At week 7, between 14-16 weeks (post-intervention), and at the 3-month follow-up timepoint, it will be administered and assess suicidal ideation and behavior for the past 7 weeks at weeks 7 and 14-16 (post-intervention), and the past 36 weeks at the 3-month follow-up assessment.
Measured: lifetime from birth to baseline time period, the month (4 weeks) prior to the initial baseline assessement prior to treatment, and at weeks 7, 14-16 (post intervention) and 3 month follow-up ratings on behavior since prior assessment up to 36 weeks.
Change in Children's Global Assessment Scale (CGAS)
The Children's Global Assessment Scale (CGAS) is a clinician-rated scale that assesses overall/global impairment across aspects of the child's life for the 4 weeks prior to the assessment. It has been found to be a reliable instrument for assessing impairment in children with psychiatric disorders. Based on clinical interview, the evaluator assigns a single score for the person's level of impairment in various domains of his/her life including relationships, school, work, and symptomatology in the 4 weeks prior to the assessment. A single global rating is provided on a scale of 1-100, with 100 being no impairment. It will be completed at baseline, week 7, between weeks 14-16 (post-intervention), and at the 3-month follow-up assessment, rating the 4 weeks prior to each of these timepoints. The repeated timepoints will allow assessment of change from baseline through the study completion at the 3-month follow-up assessment.
Measured: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the past 4 weeks prior to the assessment date
Change in Conflict Behavior Questionnaire (CBQ)
The Conflict Behavior Questionnaire is a self-report that assesses the parent-child relationship for the 2 weeks prior to the assessment. It has been found to be a reliable measure of the quality of the relationship between mother and adolescent and father and adolescent. It is completed both by the adolescent about the parents and the parent about the adolescent. It is a 20-item scale scored on a true/false scale. The total score is calculated by summing the point values of all of the items and ranges from 0-20. Higher scores indicate greater conflict in the relationship. The CBQ will be completed at baseline, week 7, between weeks 14-16 (post-intervention), and at the 3-month follow-up assessment, rating the 2 weeks prior to each of these timepoints. The repeated timepoints will allow assessment of the change from baseline through the study completion at 3-month follow-up assessment.
Measured: baseline, week 7, between weeks 14-16(post-intervention), and at the 3 month follow-up, each time rating the past 2 weeks prior to the assessment date.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201912 Jun 2023

First posted8 Jan 2019
Study start1 Aug 2019
Primary completion12 Jun 2023
Study completion12 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PTSDStudies 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: Not applicable
Intervention model: Single group
Model description: This is an open clinical trial of an psychosocial intervention for adolescents
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03795818
Sponsor's protocol ID: 7717
Status last verified: Feb 2024
First submitted: 24 Dec 2018
Last updated: 2 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Clinical Trial of Interpersonal Psychotherapy for Adolescents With PTSD Symptoms
ClinicalTrials.gov ID: NCT03795818
Acronym / sponsor ID: 7717
Conditions: PTSD
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 12 Jun 2023 (actual)
Study completion: 12 Jun 2023 (actual)
First posted: 8 Jan 2019 (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.

Detailed description

Please see the brief summary for study description.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is an open clinical trial of an psychosocial intervention for adolescents

Arm	Type	Receives
IPT-A	Other	Behavioral: Interpersonal Psychotherapy for AdolescentsInterpersonal psychotherapy for adolescents (IPT-A) is a psychosocial treatment for adolescents. It has been shown to be effective for adolescents with depression. It is now being studied as to its benefit for adolescents who meet criteria for PTSD or have subthreshold PTSD symptoms.

Who may qualify

Ages: 13 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Adolescents who meet criteria for DSM-5 diagnosis of PTSD or have elevated PTSD symptoms
English speaking adolescent and parent
Males and Females ages 13-18 years
Mild to moderate impairment in functioning

Key exclusion criteria (9 listed)

Severe impairment in functioning
Diagnoses of substance abuse, Schizophrenia, Bipolar Disorder, Conduct Disorder, primary eating disorder, psychotic symptoms
Engagement in significant self-injurious behavior in the past 3 months
Active suicidality - presence of plan and/or intent
Intellectual disability or severe learning disability

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 AdolescentsAlso: IPT-AIPT-A is a psychosocial intervention for adolescents that focuses on improving interpersonal relationships that seem to be associated with the psychiatric symptoms.	Behavioural	IPT-A

Primary outcome

Change in Child PTSD Symptom Scale (CPSS-5)
Time frame: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.
The Child Post-Traumatic Stress Disorder (PTSD) Symptom Scale (CPSS-5) is a self-report scale designed to assess PTSD symptoms in children and adolescents ages 8-18. The measure screens for stressful life events and asks about the emotional impact of these events in the 4 weeks prior to the assessment. Items are rated on a 5-point scale from 0 (not at all) to 4 (almost always) for how often the problem bothers the youth in the prior 4 weeks. A total symptom severity rating is calculated by summing the ratings of all 20 items and ranges from 0-80, with a higher score indicating greater symptom severity. The CPSS-5 will be used to assess change in PTSD symptoms through study completion at the 3-month follow-up assessment. The scale will be completed at baseline about the prior 4 weeks, at week 7 about the prior 4 weeks, between weeks 14-16 (post-intervention) about the prior 4 weeks, and at the 3-month follow-up assessment about the prior 4 weeks.
Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5)
Time frame: baseline, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.
The Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DMS-5) - Child/Adolescent Version (CAPS-CA-5) is a 30-item scale that assesses PTSD in children and adolescents ages 7 and older based on the 20 DSM-5 PTSD symptoms. Each item is given a severity rating based on symptom frequency and intensity. Ratings are given for the 4 weeks prior to each assessment timepoint. A total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms and ranges from 0-80, with a higher score indicating greater symptom severity. The CAPS-CA-5 will be used to assess change in symptoms through study completion at the 3-month follow-up assessment. The measure will be administered at baseline rating the prior 4 weeks, between weeks 14-16 (post-intervention) rating the prior 4 weeks, and at the 3-month follow-up assessment rating the prior 4 weeks.
Change in Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S)
Time frame: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date
The Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S) is a 2-item clinician-rated instrument that assesses change in global illness severity and global improvement from baseline prior to treatment to study completion at the 3-month follow-up assessment. The improvement item is scored on a 7-point scale and ranges from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). The severity item is scored on a 7-point scale and ranges from 1 (normal) to 7 (among the most extremely ill patients). It will be administered at baseline rating the prior 2 weeks, at week 7 rating the prior 2 weeks, between weeks 14-16 (post-intervention) rating the prior 2 weeks, and at the 3-month follow-up assessment rating the prior 2 weeks.

5 secondary outcomes

Change in Mood and Feelings Questionnaire (MFQ)
Time frame: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date
Change in Social Adjustment Scale-Self Report (SAS-SR)
Time frame: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: lifetime from birth to baseline time period, the month (4 weeks) prior to the initial baseline assessement prior to treatment, and at weeks 7, 14-16 (post intervention) and 3 month follow-up ratings on behavior since prior assessment up to 36 weeks.
Change in Children's Global Assessment Scale (CGAS)
Time frame: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the past 4 weeks prior to the assessment date
Change in Conflict Behavior Questionnaire (CBQ)
Time frame: baseline, week 7, between weeks 14-16(post-intervention), and at the 3 month follow-up, each time rating the past 2 weeks prior to the assessment date.

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 2 Feb 2024.
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.

Laura Mufson, Ph.D. principal investigator

Columbia University/NYSPI

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 in people with PTSD, run by New York State Psychiatric Institute 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 4 inclusion and 9 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 2 Feb 2024. 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 Child PTSD Symptom Scale (CPSS-5) (time frame: baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03795818.

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 2 Feb 2024.