AzTrials
AzTrials

SuicideNCT01537419

Attachment Based Family Therapy for Suicidal Adolescents

A study testing Attachment-Based Family Therapy and Family-Enhanced Non-directive Supportive Therapy in people with Suicide and Depression, run by Drexel University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Suicide, Depression, Family Relationships
What is being tested?
Attachment-Based Family Therapy and Family-Enhanced Non-directive Supportive Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteUnited States
Study dates
Mar 2012to Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Drexel University

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Attachment-Based Family Therapy, Family-Enhanced Non-directive Supportive Therapy
Keywords
Suicide, Depression, Family Relationships
Medical subject headings
Suicide, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attachment-Based Family TherapyBehavioural

    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.

  • Family-Enhanced Non-directive Supportive TherapyBehavioural

    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.

Study groups in NCT01537419
Study groupRoleWhat they receive
Family-Enhanced Non-directive Supportive TherapyActive comparatorFamily-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.
Receives: Behavioral: Family-Enhanced Non-directive Supportive Therapy
Attachment-Based Family TherapyExperimentalAlthough 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.
Receives: Behavioral: Attachment-Based Family Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Intensity of Suicidal Ideation Between Intake and 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.

    Measured: 16 weeks (end of treatment)

  2. Change in the Severity of Depression Symptoms Between Intake and 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.

    Measured: 16 weeks (end of treatment)

Secondary outcomes (1)
  1. Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and 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.

    Measured: 16 weeks (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01537419
Sponsor's protocol ID
1304001985
Other IDs
R01MH091059-01A1
Status last verified
Jan 2018
First submitted
13 Feb 2012
Last updated
6 Feb 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9431735
  • 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.

    PubMed 19356833
  • 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.

    PubMed 17135990
  • 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.

    PubMed 17135991
  • 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.

    PubMed 9294380
  • 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.

    PubMed 4018243
  • 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.

    PubMed 34264700
  • 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.

    PubMed 33904589
  • 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.

    PubMed 33677832
  • 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.

    PubMed 31647277
  • 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.

    PubMed 30877051
  • 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.

    PubMed 30768418

Questions about this trial

What is this clinical trial studying?

A study testing Attachment-Based Family Therapy and Family-Enhanced Non-directive Supportive Therapy in people with Suicide and Depression, run by Drexel 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 3 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: finished, as of the sponsor's last update on 6 Feb 2018. 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?

Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment (time frame: 16 weeks (end of treatment)). The study lists 2 primary outcomes in all. 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 NCT01537419, which also lists 16 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 6 Feb 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in