Clinical trial NCT03795818: IPT-A for Adolescents With PTSD Symptoms
Official title: An Open Clinical Trial of Interpersonal Psychotherapy for Adolescents With PTSD Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 9
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open clinical trial of an psychosocial intervention for adolescents
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Please see the brief summary for study description.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Severe impairment in functioning
2. Diagnoses of substance abuse, Schizophrenia, Bipolar Disorder, Conduct Disorder, primary eating disorder, psychotic symptoms
3. Engagement in significant self-injurious behavior in the past 3 months
4. Active suicidality - presence of plan and/or intent
5. Intellectual disability or severe learning disability
6. Medical illness that may interfere with treatment
7. Current physical or sexual abuse
8. Open Administration for Children's Services (ACS) case
9. Currently receiving treatment for depression and/or PTSD or have begun a medication trial for another diagnosis within the previous three months

Primary outcomes:
measure: Change in Child PTSD Symptom Scale (CPSS-5)
timeFrame: 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.
measure: Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5)
timeFrame: 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.
measure: Change in Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S)
timeFrame: 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:
measure: Change in Mood and Feelings Questionnaire (MFQ)
timeFrame: 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
measure: Change in Social Adjustment Scale-Self Report (SAS-SR)
timeFrame: 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
measure: Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 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.
measure: Change in Children's Global Assessment Scale (CGAS)
timeFrame: 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
measure: Change in Conflict Behavior Questionnaire (CBQ)
timeFrame: 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.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University/NYSPI
name: Laura Mufson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: