- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537419
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
129
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
Collaborators
Investigators
- 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
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Beck AT, Brown GK, Steer RA. Psychometric characteristics of the Scale for Suicide Ideation with psychiatric outpatients. Behav Res Ther. 1997 Nov;35(11):1039-46. doi: 10.1016/s0005-7967(97)00073-9.
- Restifo K, Bogels S. Family processes in the development of youth depression: translating the evidence to treatment. Clin Psychol Rev. 2009 Jun;29(4):294-316. doi: 10.1016/j.cpr.2009.02.005. Epub 2009 Mar 4.
- Jensen PS. After TADS, can we measure up, catch up, and ante up? J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1456-60. doi: 10.1097/01.chi.0000237712.81378.9d. No abstract available.
- Brent DA. Glad for what TADS adds, but many TADS grads still sad. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1461-4. doi: 10.1097/01.chi.0000237708.28013.2a. No abstract available.
- Beck, A., Steer, R. & Brown, G. (1996) The Beck Depression Inventory-Second Edition. San Antonio, TX: Psychological Corporation.
- Garber, J., Robinson, N.S., & Valentiner, D. (1997). The relation between parenting and adolescent depression: Self-worth as a mediator. Journal of Adolescent Research, 12, 12-33.
- Brent DA, Holder D, Kolko D, Birmaher B, Baugher M, Roth C, Iyengar S, Johnson BA. A clinical psychotherapy trial for adolescent depression comparing cognitive, family, and supportive therapy. Arch Gen Psychiatry. 1997 Sep;54(9):877-85. doi: 10.1001/archpsyc.1997.01830210125017.
- Bloom BL. A factor analysis of self-report measures of family functioning. Fam Process. 1985 Jun;24(2):225-39. doi: 10.1111/j.1545-5300.1985.00225.x.
- Reynolds, W., & Mazza, J. (1999). Assessment of suicidal ideation in inner-city children and young adolescents: Reliability and validity of the Suicidal Ideation Questionnaire-JR. School Psychology Review, 28, 17-30.
- Abbott CH, Zisk A, Herres J, Diamond GS, Krauthamer Ewing S, Kobak R. Exploring the relations between interpersonal risk and adolescent suicidality during treatment. J Consult Clin Psychol. 2021 Jun;89(6):528-536. doi: 10.1037/ccp0000656.
- Ibrahim M, Levy S, Gallop B, Krauthamer Ewing S, Hogue A, Chou J, Diamond G. Therapist Adherence to Two Treatments for Adolescent Suicide Risk: Association to Outcomes and Role of Therapeutic Alliance. Fam Process. 2022 Mar;61(1):183-197. doi: 10.1111/famp.12660. Epub 2021 Apr 27.
- Zisk A, Abbott CH, Bounoua N, Diamond GS, Kobak R. Parent-teen communication predicts treatment benefit for depressed and suicidal adolescents. J Consult Clin Psychol. 2019 Dec;87(12):1137-1148. doi: 10.1037/ccp0000457. Epub 2019 Oct 24.
- Abbott CH, Zisk A, Bounoua N, Diamond GS, Kobak R. Predicting Patterns of Treatment Response and Outcome for Adolescents Who Are Suicidal and Depressed. J Am Acad Child Adolesc Psychiatry. 2019 Sep;58(9):897-906. doi: 10.1016/j.jaac.2018.12.013. Epub 2019 Mar 12.
- Diamond GS, Kobak RR, Krauthamer Ewing ES, Levy SA, Herres JL, Russon JM, Gallop RJ. A Randomized Controlled Trial: Attachment-Based Family and Nondirective Supportive Treatments for Youth Who Are Suicidal. J Am Acad Child Adolesc Psychiatry. 2019 Jul;58(7):721-731. doi: 10.1016/j.jaac.2018.10.006. Epub 2018 Oct 30.
- Bounoua N, Abbott C, Zisk A, Herres J, Diamond G, Kobak R. Emotion regulation and spillover of interpersonal stressors to postsession insight among depressed and suicidal adolescents. J Consult Clin Psychol. 2018 Jul;86(7):593-603. doi: 10.1037/ccp0000316.
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)
March 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
February 13, 2012
First Submitted That Met QC Criteria
February 17, 2012
First Posted (Estimate)
February 23, 2012
Study Record Updates
Last Update Posted (Actual)
February 6, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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