Trial Outcomes & Findings for Attachment Based Family Therapy for Suicidal Adolescents (NCT NCT01537419)

Last Updated: 2018-02-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

16 weeks (end of treatment)

Results posted on

2018-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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. 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.
Overall Study STARTED	63	66
Overall Study COMPLETED	52	54
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Attachment Based Family Therapy for Suicidal Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family-Enhanced Non-directive Supportive Therapy n=63 Participants 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.	Attachment-Based Family Therapy n=66 Participants 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 n=129 Participants Total of all reporting groups
Age, Customized <=15 Years Old	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Age, Customized >15 Years Old	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sexual Orientation Heterosexual	50 Participants n=5 Participants	38 Participants n=7 Participants	88 Participants n=5 Participants
Sexual Orientation Lesbian/Gay	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Sexual Orientation Bisexual	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sexual Orientation Questioning	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Socioeconomic Status Below Poverty Level	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Socioeconomic Status Above Poverty Level	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks (end of treatment)

Outcome measures

Outcome measures
Measure	Family-Enhanced Non-directive Supportive Therapy n=52 Participants 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.	Attachment-Based Family Therapy n=54 Participants 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.
Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment	-27.42 units on a scale Standard Deviation 2.52	-31.55 units on a scale Standard Deviation 2.50

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family-Enhanced Non-directive Supportive Therapy n=52 Participants 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.	Attachment-Based Family Therapy n=54 Participants 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.
Change in the Severity of Depression Symptoms Between Intake and End of Treatment	-4.87 units on a scale Standard Deviation 0.50	-5.40 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family-Enhanced Non-directive Supportive Therapy n=53 Participants 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.	Attachment-Based Family Therapy n=55 Participants 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.
Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment	-1.058 units on a scale Standard Deviation 2.95232	-1.2538 units on a scale Standard Deviation 2.71817

Adverse Events

Family-Enhanced Non-directive Supportive Therapy

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Attachment-Based Family Therapy

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Family-Enhanced Non-directive Supportive Therapy n=63 participants at risk 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.	Attachment-Based Family Therapy n=66 participants at risk 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.
Psychiatric disorders Suicide Attempt	4.8% 3/63 • Number of events 3 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.	12.1% 8/66 • Number of events 10 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.
Psychiatric disorders Non-suicidal self-injury	11.1% 7/63 • Number of events 9 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.	10.6% 7/66 • Number of events 11 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.
Psychiatric disorders Hospitalization	9.5% 6/63 • Number of events 6 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.	3.0% 2/66 • Number of events 3 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.
Psychiatric disorders Emergency Room Visit	1.6% 1/63 • Number of events 1 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.	4.5% 3/66 • Number of events 3 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.
Psychiatric disorders High level of suicidal ideation	17.5% 11/63 • Number of events 21 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.	18.2% 12/66 • Number of events 23 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.
Psychiatric disorders Abuse/Neglect	7.9% 5/63 • Number of events 9 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.	4.5% 3/66 • Number of events 3 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.
Psychiatric disorders Incarceration	0.00% 0/63 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.	3.0% 2/66 • Number of events 2 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.
Psychiatric disorders Other	11.1% 7/63 • Number of events 8 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.	3.0% 2/66 • Number of events 2 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.

Additional Information

Guy Diamond, Ph.D.

Center for Family Intervention Science, Drexel University

Phone: 215-571-3420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place