- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571571
Application and Evaluation of Transference Focused Psychotherapy Modified for Adolescents (TFP-A)
Normal adolescence requires a successful resolution of identity crisis, which results in the development of satisfying relationships, success in school/work pursuits, and achievement of personal goals. Adolescents, who do not resolve this crisis, are at high risk for problems in those areas of functioning. Transference Focused Psychotherapy for Adolescents (TFP-A) is a treatment that specifically addresses these issues, permitting adolescents to develop satisfying friendships, more appropriate interactions with authority, and achieve realistic life goals.
This study will evaluate the application of TFP-A, (a empirically validated treatment for adults with identity disturbance), to adolescents exhibiting the same behavioral and identity pathology. Subjects will be females; ages 14-21, with behaviors associated with identity problems, interpersonal difficulties with teachers, parents and/or peers, and live with their families. These adolescents will be randomly assigned to one of two treatment cells, TFP-A or Treatment as Usual (TAU). Subjects in TFP-A will receive weekly individual therapy for six months. The TAU group will receive standard individual therapy in the Outpatient Department. Both will receive medication as necessary. All subjects will participate in initial, weekly, and bi-monthly assessments during the six-month treatment period, and participate in a naturalistic follow-up study for an additional six months.
Hypothesis:
Adolescents with identity problems as seen in interpersonal, school, and/or family difficulties in the Transference Focused Psychotherapy for Adolescents (TFP-A) group will reduce these problem behaviors and improve management of their feelings and moods compared to adolescents with identity problems in the treatment as usual control group (TAU).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna E Odom, Ph.D.
- Phone Number: 914-997-5946
- Email: ano9021@med.cornell.edu
Study Contact Backup
- Name: Pamela A Foelsch, Ph.D.
- Phone Number: 212-213-9879
Study Locations
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New York
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White Plains, New York, United States, 10605
- Recruiting
- New York-Presbyterian Hospital
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Contact:
- Maura L Lehr, LCSW
- Phone Number: 914-997-5866
- Email: mll9001@nyp.org
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Principal Investigator:
- Anna E Odom, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female Adolescents, ages 14-21
- A score of five out of nine critical items on the Borderline Personality Disorder Dimension Interview Scale.
- Have interpersonal difficulties in school, family, and/or peer functioning.
- Live at home with family.
- Willingness to attend evaluation sessions and weekly, individual therapy.
Exclusion Criteria:
- The presence of psychosis, substance dependence, non-verbal learning disability, antisocial behavior, and/or primary diagnoses of eating disorder, bipolar disorder, and obsessive-compulsive disorder.
- The need for hospitalization for symptom management.
- Significant cognitive impairment (Full Scale IQ <85).
- The presence of a life-threatening medical illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TFP-A
Specific aspects of TFP-A involve the setting up of a treatment contract/collaboration between patient and therapist to deal with the likely threats both to the treatment and to the patient's well being that may occur in the course of the treatment.
After the behavioral symptoms of identity pathology are contained through structure and limit setting, the psychological structure that is believed to be the core of identity pathology are analyzed.
In particular, treatment would involve the family in setting up the contract parameters, provide a psychoeducational component to the family and patient, inclusion of school personnel as appropriate to reinforce contract parameters, place an emphasis on the technique of clarification to understand specific emotional states.
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Individual psychotherapy with parent collateral/psychoeducation as necessary.
Other Names:
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Active Comparator: Control
The Control Group is treatment as usual in the outpatient clinic.
Treatment in this arm will be carried out by therapists in the Outpatient Department.
Treatment will be determined by the therapist(s) and carried out according to their particular orientation and their assessment of patient's needs.
It is expected based on clinic data that the majority of patients will be seen at least one time per week.
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Individual psychotherapy and family interventions (as needed)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in interpersonal difficulties with parents, teachers, and/or peers. Improved management of their feelings and moods. Reduction in other problems behaviors (i.e. substance use, self-injurious behaviors)
Time Frame: Subjects will be assessed at entry, 2 month, 4 months, 6 months, 8 months 10 months, and 12 months
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Subjects will be assessed at entry, 2 month, 4 months, 6 months, 8 months 10 months, and 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Anna E Odom, Ph.D., Weill Medical College of Cornell University
Publications and helpful links
General Publications
- Clarkin JF, Foelsch PA, Levy KN, Hull JW, Delaney JC, Kernberg OF. The development of a psychodynamic treatment for patients with borderline personality disorder: a preliminary study of behavioral change. J Pers Disord. 2001 Dec;15(6):487-95. doi: 10.1521/pedi.15.6.487.19190.
- Clarkin JF, Levy KN, Lenzenweger MF, Kernberg OF. Evaluating three treatments for borderline personality disorder: a multiwave study. Am J Psychiatry. 2007 Jun;164(6):922-8. doi: 10.1176/ajp.2007.164.6.922.
- Clarkin JF, Levy KN, Lenzenweger MF, Kernberg OF. The Personality Disorders Institute/Borderline Personality Disorder Research Foundation randomized control trial for borderline personality disorder: rationale, methods, and patient characteristics. J Pers Disord. 2004 Feb;18(1):52-72. doi: 10.1521/pedi.18.1.52.32769.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0610008834
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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