Identity PathologyTFP-ANCT00571571
Application and Evaluation of Transference Focused Psychotherapy Modified for Adolescents
A study testing Psychotherapy and Individual Psychotherapy in people with Identity Pathology and Behavior Problems, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women only
- Conditions the study is for
- Identity Pathology, Behavior Problems
- What is being tested?
- Psychotherapy and Individual Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2009
- 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 14 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pamela A Foelsch, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
New York-Presbyterian Hospital
White Plains, New York, 10605
Maura L Lehr, LCSW, 914-997-5866, mll9001@nyp.org
Anna E Odom, Ph.D.
About this study
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.
Read more
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).
- Conditions
- Identity Pathology, Behavior Problems
- Being tested
- Psychotherapy, Individual Psychotherapy
- Keywords
- Identity difussion, Adolescent psychotherapy, Transference Focused Psychotherapy for Adolescents, Identity, Identity crisis, Identity pathology
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Also called TFP-A, Transference Focused Psychotherapy for Adolescents
Individual psychotherapy with parent collateral/psychoeducation as necessary.
Individual PsychotherapyBehavioural
Individual psychotherapy and family interventions (as needed)
| Study group | Role | What they receive |
|---|---|---|
| TFP-A | Experimental | 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. Receives: Behavioral: Psychotherapy |
| Control | Active comparator | 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. Receives: Behavioral: Individual Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Subjects will be assessed at entry, 2 month, 4 months, 6 months, 8 months 10 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Identity PathologyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Anna E Odom, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571571
- Sponsor's protocol ID
- 0610008834
- Acronym
- TFP-A
- Status last verified
- Jan 2011
- First submitted
- 11 Dec 2007
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11778390Clarkin 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.
PubMed 17541052Clarkin 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.
PubMed 15061344
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Evaluation of Transference Focused Psychotherapy Modified for Adolescents
- ClinicalTrials.gov ID
- NCT00571571
- Acronym / sponsor ID
- TFP-A / 0610008834
- Conditions
- Identity Pathology, Behavior Problems
- Keywords
- Identity difussion, Adolescent psychotherapy, Transference Focused Psychotherapy for Adolescents, Identity, Identity crisis, Identity pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 12 Dec 2007 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFP-A | Experimental | Behavioral: PsychotherapySpecific 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. |
| Control | Active comparator | Behavioral: Individual PsychotherapyThe 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. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| PsychotherapyAlso: TFP-A, Transference Focused Psychotherapy for AdolescentsIndividual psychotherapy with parent collateral/psychoeducation as necessary. | Behavioural | TFP-A |
| Individual PsychotherapyIndividual psychotherapy and family interventions (as needed) | Behavioural | Control |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
- Background: PubMed 11778390Clarkin 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.
- Background: PubMed 17541052Clarkin 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.
- Background: PubMed 15061344Clarkin 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.
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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.
Pamela A Foelsch, Ph.D. contact
Anna E Odom, Ph.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy and Individual Psychotherapy in people with Identity Pathology and Behavior Problems, run by Weill Medical College of Cornell University 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jan 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna E Odom, Ph.D. (914-997-5946, ano9021@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT00571571, which also lists 3 linked publications.
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 4 Jan 2011.