Attachment Based Family Therapy for Suicidal Adolescents

January 8, 2018 updated by: Drexel University

Attachment Based Family Therapy (ABFT) for Suicidal Adolescents

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment
Time Frame: 16 weeks (end of treatment)
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. The scale ranges from 0 to 90, with a score of 0 being representative of no suicidal ideation, and a score of 31 or greater indicating severe suicidal ideation.
16 weeks (end of treatment)
Change in the Severity of Depression Symptoms Between Intake and End of Treatment
Time Frame: 16 weeks (end of treatment)
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. The scale ranges from 0 to 63, with a higher score being representative of a greater clinical magnitude of depression: a total score of 0-13 is considered minimal depression, 14-19 is mild depression, 20-28 is moderate depression, and 29-63 is severe depression.
16 weeks (end of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment
Time Frame: 16 weeks (end of treatment)
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). The scale ranges from 10 to 40, with a score of 10 being representative of no family conflict and a score of 40 being representative of the greatest magnitude of family conflict. Therefore, a decrease in score represents and decrease in self-reported family conflict.
16 weeks (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Drexel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guy Diamond, PhD, Drexel University
  • Principal Investigator: Roger Kobak, PhD, University of Delaware

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1304001985
  • R01MH091059-01A1 (U.S. NIH Grant/Contract)

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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