Attachment Based Family Therapy for Suicidal Adolescents

Sponsor
Drexel University (Other)
Overall Status
Completed
CT.gov ID
NCT01537419
Collaborator
National Institute of Mental Health (NIMH) (NIH)
129
1
2
57
2.3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Attachment-Based Family Therapy
  • Behavioral: Family-Enhanced Non-directive Supportive Therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Attachment Based Family Therapy (ABFT) for Suicidal Adolescents
Actual Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Drexel University Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Drexel University
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Guy Diamond, PhD, Drexel University
  • Principal Investigator: Roger Kobak, PhD, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Drexel University
ClinicalTrials.gov Identifier:
NCT01537419
Other Study ID Numbers:
  • 1304001985
  • R01MH091059-01A1
First Posted:
Feb 23, 2012
Last Update Posted:
Feb 6, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Drexel University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Arm/Group Description 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. 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. 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.
Period Title: Overall Study
STARTED 63 66
COMPLETED 52 54
NOT COMPLETED 11 12

Baseline Characteristics

Arm/Group Title Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy Total
Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Participants 63 66 129
Age, Customized (Count of Participants)
<=15 Years Old
40
63.5%
36
54.5%
76
58.9%
>15 Years Old
23
36.5%
30
45.5%
53
41.1%
Sex: Female, Male (Count of Participants)
Female
52
82.5%
55
83.3%
107
82.9%
Male
11
17.5%
11
16.7%
22
17.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
9
14.3%
11
16.7%
20
15.5%
Not Hispanic or Latino
54
85.7%
55
83.3%
109
84.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
2
3.2%
0
0%
2
1.6%
Asian
1
1.6%
2
3%
3
2.3%
Native Hawaiian or Other Pacific Islander
1
1.6%
0
0%
1
0.8%
Black or African American
33
52.4%
31
47%
64
49.6%
White
16
25.4%
21
31.8%
37
28.7%
More than one race
4
6.3%
6
9.1%
10
7.8%
Unknown or Not Reported
6
9.5%
6
9.1%
12
9.3%
Sexual Orientation (Count of Participants)
Heterosexual
50
79.4%
38
57.6%
88
68.2%
Lesbian/Gay
2
3.2%
8
12.1%
10
7.8%
Bisexual
9
14.3%
13
19.7%
22
17.1%
Questioning
2
3.2%
7
10.6%
9
7%
Socioeconomic Status (Count of Participants)
Below Poverty Level
19
30.2%
21
31.8%
40
31%
Above Poverty Level
44
69.8%
45
68.2%
89
69%

Outcome Measures

1. Primary Outcome
Title Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment
Description 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.
Time Frame 16 weeks (end of treatment)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Arm/Group Description 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. 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. 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.
Measure Participants 52 54
Mean (Standard Deviation) [units on a scale]
-27.42
(2.52)
-31.55
(2.50)
2. Primary Outcome
Title Change in the Severity of Depression Symptoms Between Intake and End of Treatment
Description 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.
Time Frame 16 weeks (end of treatment)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Arm/Group Description 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. 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. 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.
Measure Participants 52 54
Mean (Standard Deviation) [units on a scale]
-4.87
(0.50)
-5.40
(0.50)
3. Secondary Outcome
Title Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment
Description 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.
Time Frame 16 weeks (end of treatment)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Arm/Group Description 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. 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. 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.
Measure Participants 53 55
Mean (Standard Deviation) [units on a scale]
-1.058
(2.95232)
-1.2538
(2.71817)

Adverse Events

Time Frame
Adverse Event Reporting Description Given the definitions of expected outcomes, the following outcomes will be reported as SAEs if it is possible that they may be related to the completion of an assessment (e.g., participant becomes suicidal during or immediately following an assessment) or participation in treatment (e.g., participant becomes suicidal during or immediately following a treatment session): suicide attempt, death by suicide, psychiatric hospitalization.
Arm/Group Title Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Arm/Group Description 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. 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. 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.
All Cause Mortality
Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/63 (0%) 0/66 (0%)
Serious Adverse Events
Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/63 (0%) 0/66 (0%)
Other (Not Including Serious) Adverse Events
Family-Enhanced Non-directive Supportive Therapy Attachment-Based Family Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 27/63 (42.9%) 27/66 (40.9%)
Psychiatric disorders
Suicide Attempt 3/63 (4.8%) 3 8/66 (12.1%) 10
Non-suicidal self-injury 7/63 (11.1%) 9 7/66 (10.6%) 11
Hospitalization 6/63 (9.5%) 6 2/66 (3%) 3
Emergency Room Visit 1/63 (1.6%) 1 3/66 (4.5%) 3
High level of suicidal ideation 11/63 (17.5%) 21 12/66 (18.2%) 23
Abuse/Neglect 5/63 (7.9%) 9 3/66 (4.5%) 3
Incarceration 0/63 (0%) 0 2/66 (3%) 2
Other 7/63 (11.1%) 8 2/66 (3%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Guy Diamond, Ph.D.
Organization Center for Family Intervention Science, Drexel University
Phone 215-571-3420
Email gd342@drexel.edu
Responsible Party:
Drexel University
ClinicalTrials.gov Identifier:
NCT01537419
Other Study ID Numbers:
  • 1304001985
  • R01MH091059-01A1
First Posted:
Feb 23, 2012
Last Update Posted:
Feb 6, 2018
Last Verified:
Jan 1, 2018