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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00571571
Other study ID # 0610008834
Secondary ID
Status Recruiting
Phase N/A
First received December 11, 2007
Last updated January 3, 2011
Start date October 2007
Est. completion date December 2009

Study information

Verified date January 2011
Source Weill Medical College of Cornell University
Contact Anna E Odom, Ph.D.
Phone 914-997-5946
Email ano9021@med.cornell.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 21 Years
Eligibility Inclusion Criteria:

1. Female Adolescents, ages 14-21

2. A score of five out of nine critical items on the Borderline Personality Disorder Dimension Interview Scale.

3. Have interpersonal difficulties in school, family, and/or peer functioning.

4. Live at home with family.

5. Willingness to attend evaluation sessions and weekly, individual therapy.

Exclusion Criteria:

1. 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.

2. The need for hospitalization for symptom management.

3. Significant cognitive impairment (Full Scale IQ <85).

4. The presence of a life-threatening medical illness.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychotherapy
Individual psychotherapy with parent collateral/psychoeducation as necessary.
Individual Psychotherapy
Individual psychotherapy and family interventions (as needed)

Locations

Country Name City State
United States New York-Presbyterian Hospital White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Subjects will be assessed at entry, 2 month, 4 months, 6 months, 8 months 10 months, and 12 months Yes
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