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Attachment Based Family Therapy for Suicidal Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Drexel University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Drexel University
ClinicalTrials.gov Identifier:
NCT01537419
First received: February 13, 2012
Last updated: May 1, 2014
Last verified: April 2014
  Purpose

This study will evaluate the efficacy of attachment based family therapy (ABFT) for treatment of suicidality in adolescents. The study will compare 16 weeks of treatment with ABFT to a control condition Family Enhanced Non-directive Supportive Therapy (FE-NST).


Condition Intervention Phase
Suicide
Depression
Family Relationships
Behavioral: Attachment-Based Family Therapy
Behavioral: Family-Enhanced Non-directive Supportive Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attachment Based Family Therapy (ABFT) for Suicidal Adolescents

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Change in the Intensity of Suicidal Ideation [ Time Frame: 16, 32 and 52 weeks ] [ Designated as safety issue: Yes ]
    The Suicidal Ideation Questionnaire-JR is a 15-item self-report assessment. It is based on Reynolds' theoretical notion of suicidality forming a continuum ranging from thoughts of death, thoughts of wanting to be dead, general and specific suicidal plans, preparations for carrying out plans, and actual suicide attempts.


Secondary Outcome Measures:
  • Change in the evidence of family conflict between parent and youth after intervention [ Time Frame: 16, 32 and 52 weeks ] [ Designated as safety issue: No ]
    The Self-Report of Family Functioning consists of 10 items selected from a number of well-known family assessment measures (Family Environment Scale, Family Concept Q-Sort, Family Adaptability and Cohesion Scale, and Family Assessment Measure).

  • Change in the severity of depression symptoms [ Time Frame: 16, 32 and 52 weeks ] [ Designated as safety issue: Yes ]
    Beck Depression Inventory-II. The second edition of the BDI is a widely-used, 21-item self-report instrument designed to assess the severity of depressive symptoms in adults and adolescents. The BDI-II has 21 items and takes approximately 5 minutes to complete.


Estimated Enrollment: 130
Study Start Date: March 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Family-Enhanced Non-directive Supportive Therapy
Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
Behavioral: Family-Enhanced Non-directive Supportive Therapy
Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
Experimental: Attachment-Based Family Therapy
Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.
Behavioral: Attachment-Based Family Therapy
Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.

Detailed Description:

Suicide is the third leading cause of death for American adolescents. Nearly one million adolescents a year attempt suicide and about 500,000 adolescents a year are admitted to psychiatric hospitals for suicide attempts or serious suicidal ideation. This leads to high emotional costs for families and financial cost for the health system. Yet, no medication, and less than 10 psychotherapy studies have focused on suicidal youth and findings are mixed. There has been a call for new and innovative approaches for depression treatment highlights the need for alternative interventions for suicidal youth as well. Attachment-Based Family Therapy (ABFT) offers a promising alternative to prior treatments. It is a manualized family therapy targeting processes associated with suicide and depression. ABFT seeks to improve the adolescent-caregiver relationship by increasing the family's capacity for discussing and negotiating affectively charged issues in the relationship. Improvements in the attachment relationship provide adolescents with improved capacity for affect regulation and the ability to use the caregiver as a source of protection and support. These strengths buffer adolescents against suicide and other risk behaviors. Four studies have demonstrated that ABFT can reduce suicidal ideation and depressive symptoms with an average effect size of .97. Unfortunately, interpretation of these studies is compromised by lack of a controlled comparison treatment. This study aims to test the efficacy of ABFT using a comparison group that controls for treatment dose, duration, therapist expertise, ecological factors, and family involvement. The study includes one year follow-up data, assessment staff blind to treatment condition and tests of the purported active ingredients of ABFT. Putative change processes will be tested including: a)adolescents' expectancies for parent availability, b) emotion regulation during parent-adolescent conflict discussions, and c) resolution of loss and abuse. To test this, Dr. Kobak, a leading adolescent attachment researcher, will use the Adult Attachment Interview and observational coding of the family interaction task to test these treatment mechanisms. If successful, the findings will provide evidence for both the efficacy and specificity of a family based treatment mechanism. The investigators will recruit and randomize 130 adolescents to 16 weeks of ABFT or Family-Enhanced Non-directive Supportive Therapy (FE-NST). Assessments will be conducted at baseline, 8, 16, 32 and 52 weeks. The primary and secondary aims assess whether ABFT reduces suicidal ideation, depression, family conflict, and future suicide attempts more effectively than control. Exploratory aims test a) whether ABFT can improve parent adolescent attachment, b) if attachment mediates outcome, and if a history of trauma, parental depression or family conflict moderate outcome. The study targets adolescents with severe and persistent suicidal ideation selected from inner city, minority youth.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents between the ages of 12 and 18
  • Adolescents endorse severe suicidal ideation (SIQ-JR > 31) and moderate depression (BDI-II > 20) at two time points (1 to 3 days)
  • At least one primary parent or caregiver must participate in the assessment and treatment. This could be a biological parent, stepparent, grandparent, other relative, or a foster parent, who has at least frequent contact with the subject. When possible both parents will participate in the assessment and treatment. Legal custody is always considered (e.g., divorced parents). Having all family members present at every session is not required. Many individual meetings with the subject or the parent are planned in both treatments.

Exclusion Criteria:

  • Evidence of imminent risk of harm to self or others that cannot be safely treated on an outpatient basis
  • Evidence of psychotic features [as reported on the Diagnostic Interview Schedule for Children; Voice Diagnostic Interview Schedule for Children (VDISC)]
  • Evidence of suffering from severe cognitive impairment (e.g., mental retardation, severe developmental disorders) as evidenced by educational records, parental report and/or clinical impression).
  • Subjects taking antidepressant medication for depression for less than 6 weeks prior to the screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537419

Contacts
Contact: Guy Diamond, PhD 215-571-3420 gd342@drexel.edu
Contact: Stephanie Ewing, PhD, MPH 215-571-3418 sewing@drexel.edu

Locations
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephanie Ewing, PhD, MPH    215-571-3418    sewing@drexel.edu   
Principal Investigator: Diamond Guy, PhD         
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Guy Diamond, PhD Drexel University
Principal Investigator: Roger Kobak, PhD University of Delaware
  More Information

Additional Information:
Publications:
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT01537419     History of Changes
Other Study ID Numbers: 1304001985, R01MH091059-01A1
Study First Received: February 13, 2012
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Drexel University:
Suicide
Depression
Family Relationships

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicide
Behavioral Symptoms
Mental Disorders
Mood Disorders
Self-Injurious Behavior

ClinicalTrials.gov processed this record on November 20, 2014