- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01195740
Family Therapy as Hospital Aftercare for Adolescent Suicide Attempters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Annually, more adolescents and young adults in the United States die from suicide than from cancer, heart disease, AIDS, birth defects, stroke, pneumonia, influenza and chronic lung disease combined (U.S. Public Health Service, 1999). Each year approximately 1 in 5 teenagers seriously consider killing themselves, over one million teenagers attempt suicide, and between 1,600 and 2,000 die by suicide (U.S. Public Health Service, 1999). Clearly, the need for more empirically based treatment models is urgently needed.
Typically, after a suicide attempt or reporting of suicidal ideation with an intent or plan to kill themselves, adolescents are treated in a psychiatric hospital. In the past, an inpatient stay could provide intensive individual, group, family, and or medication therapy. However, managed care has shifted the goal of hospitalizations from treatment to stabilization. Adolescents are discharged when they are deemed to be no longer a threat to themselves, leaving the treatment of precipitating factors to outpatient aftercare. In a recent review of 21 studies on compliance with aftercare, Daniel and colleagues (2004) found that a majority of youth do received aftercare, but that noncompliance is very high. Very little evidence was found to support the effectiveness of aftercare. Surprisingly there are no studies on preventing adolescent reattempts of suicide after hospitalization. Important studies by Harrington et al. (1998) and King et al. (2007) have shown some promising results for aftercare reducing suicidal ideation, but no published studies have looked at preventing reattempts. Given the dearth of treatment studies for youth attempting suicide in general, it is not surprising that there are even fewer studies of aftercare for this population. Yet, given the high cost of even a short inpatient treatment, developing and testing effective aftercare programs that build on the gains made in inpatient treatment for youth who attempt suicide seems warranted.
One promising outpatient treatment approach for this population is Attachment-Based Family Therapy (ABFT; Diamond et al., 2002). ABFT is a manualized, brief (i.e., 12 to 16 week) family-based model designed specifically for treating depressed and suicidal adolescents. The model aims to reduce adolescent depression, suicidal ideation, family conflict, parental criticism, and adolescent isolation and hopelessness; all factors associated with adolescent suicide attempts (e.g., Brent et al., 1988). To accomplish these goals with the parent, ABFT aims to increase parental warmth, communication skills, and appropriate monitoring. For the adolescent, treatment aims to improve interpersonal problem solving, emotional regulation, and reengagement with positive prosocial activities (e.g., school, job, peers). As communication improves and trust is rebuilt, the parents reclaim their position as a secure base for adolescent development. The family becomes a context where adolescents learn to express their emotions and thoughts (including their suicidal ideation) in a differentiated and regulated manner, problem solve, and control their impulses. In many families, repairing the attachment rupture requires a "working through" of prior traumatic events (e.g., loss, divorce, abuse) often associated with the suicidal behavior. As adolescents become less preoccupied with suicide ideation and family conflict, treatment focuses on parents helping their adolescent navigate the challenges of school, peer relations and other life domains.
ABFT has recently proven effective in reducing suicidal ideation and depressive symptoms in a non-hospitalized population identified in primary care (Diamond et al., 2007). This grant will set the foundation for a programmatic look at treating adolescents who have been psychiatrically hospitalized for attempting suicide. This study will have two improvements over current aftercare services. First, it will improve the quality of aftercare by using an empirically based, family-based, manualized treatment. Second, it will rely on a continuity of care model where aftercare treatment begins while families are still in the hospital, potentially enhancing treatment compliance once the adolescent leaves the hospital.
- Objective 1: Develop a collaborative relationship with Belmont Psychiatric hospital and their Therapeutic Bridge Program to foster a research infrastructure that can support future adolescent suicide clinical trials research. This will include integrating standardized assessment tools into the inpatient procedures and establishing procedures for making referrals to the research program.
- Objective 2: Evaluate the feasibility and acceptability of ABFT outpatient aftercare for youth with a suicide attempt, after discharge from inpatient care. This will be evaluated by our ability to make contact with at least 80% of eligible patients, collect weekly follow up data, obtain at least 90% post treatment data, meet our recruitment goals, retain patients in treatment for at least 10 sessions, and be rated high on patient report of treatment acceptability and satisfaction.
- Objective 3: In an exploratory fashion, examine the differential effect sizes between Enhanced Usual Care (EUC) and ABFT at 14 weeks post hospital discharge for a) preventing future suicide attempts, b) reducing associated risk factors (suicide ideation, depression, and family conflict) and c) increasing treatment compliance (e.g., time to first session, number of sessions attended).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- in inpatient mental health treatment
- report a suicide attempt in the past month
- have a primary caretaker willing to participate in aftercare
- are able to travel to CHOP
- have no history of psychosis or low intellectual capacity
- speak adequate English.
Exclusion Criteria:
- being discharged to a residential placement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enhanced Usual Care
|
Belmont offers the Therapeutic Bridge Program, funded by the Pew Charitable Trusts, which helps adolescents make the transition from the hospital back to home, school and community behavioral health services.
The program serves as a "bridge" between inpatient and outpatient care during the first 90 days after discharge, linking them to supportive services.
Aftercare begins at the point of intake.
Several discharge planning meetings are held with the adolescent and parents during the inpatient stay.
The range of services are based on the patient and families' need, and may include meeting with school personnel , conducting home visits or making referrals to other community services agencies.
The main objective is to secure outpatient mental health services for the patient.
These services will be enhanced by the weekly research tracking, assessment and 24-hour crisis phone line which will call into a cell phone rotated among the licensed mental health professionals on the research team.
|
Experimental: Attachment Based Family Therapy
|
ABFT has three phases.
In phase one, treatment focuses on helping the adolescent identify past and present family conflicts that have strained the attachment bond and damaged trust.
Adolescents and parents are taught new communication and affect regulation skills in preparation for reparative conversations in phase two.
This phase of treatment involves adolescents and parents discussing these past and present conflicts using their new communication skills.
The final phase of treatment focuses on promoting adolescent autonomy (i.e., improving school productivity, finding a job, etc.).
For the suicidal/depressed adolescent, this can decrease isolation and increase exposure to positive experiences.
To accomplish these goals, there are five ABFT treatment tasks.
Each task may take one or several sessions.
Youth randomized to this condition will receive approximately 14 weeks of ABFT.
One orientation meeting will occur, whenever possible, on the inpatient unit prior to discharge.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client Satisfaction Questionnaire (CSQ)
Time Frame: 14 weeks
|
The CSQ is a 31 item questionnaire with responses on a 4-point scale.
There are no subscales, and a total score is computed by summing scores across items.
Higher scores indicate higher levels of satisfaction.
In a variety of studies, the CSQ has demonstrated good internal consistency and predictive validity and has been reviewed favorably by several independent sources (Attkisson & Greenfield, 1994; Ogles et al., 2002).
The CSQ has 8 items, and takes approximately 5 minutes to complete
|
14 weeks
|
Cornell Services Index (CSI)
Time Frame: baseline, 14 weeks
|
The CSI is a self-report measure of medical and psychological services received (treatment utilization).
We will complete information on type of provider, site of service, time to first session, and frequency of service, psychiatric assessments, pharmacotherapy, and individual and family therapy.
The Cornell Services Index has been found to have good test-retest and interrater reliability.
The Cornell has 32 items, and takes approximately 10 minutes to complete.
|
baseline, 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory (BDI)
Time Frame: baseline, weekly, 14 weeks
|
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 high internal reliability (alpha = .91)
and is highly and positively correlated with other measures of depression.
The sensitivity and specificity for detecting depression in psychiatric patients has been established.
With the original BDI, we found an alpha of .85 for 97 African American adolescents screened for a depression treatment pilot study.
The BDI-II has 21 items, and takes approximately 5 minutes to complete.
|
baseline, weekly, 14 weeks
|
Relatedness Scale (RS)
Time Frame: baseline, 14 weeks
|
The relatedness scale is a 23-item measure assessing the relationships between children and their mother and father.
There are two subscales: psychological proximity and emotional quality of the relationship.
The psychological proximity seeking section of the measure has 12 statements each with a four point likert scale ranging from not at all true to very true.
Similarly, the emotional quality section has 11 statements with a four-point response set ranging from almost never to almost always.
The total score for the measure is the sum of the responses in each section.
|
baseline, 14 weeks
|
Relationship Structures Questionnaire (RSQ)
Time Frame: Baseline, 14 weeks
|
The RS is a self-report measure assessing attachment patterns in four domains: mother, father, romantic partner, and best friend.
Each domain has ten items assessed on a 7-point likert scale ranging from strongly disagree to strongly agree.
Each domain generates two scores: one for attachment related avoidance and the other for attachment related anxiety.
The RS measures one component of attachment (i.e., avoidance and anxiety), which is a central change mechanism of ABFT.
|
Baseline, 14 weeks
|
Suicide Ideation Questionnaire (SIQ-JR)
Time Frame: baseline, weekly, 14 weeks
|
The SIQ-JR is a 15-item version of the Suicidal Ideation Questionnaire.
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.
It was originally designed for younger adolescents but has been frequently used in studies with older adolescents.
|
baseline, weekly, 14 weeks
|
Columbia Suicide-Severity Scale (C-SSRS)
Time Frame: baseline, 14 weeks (if attempt made during treatment)
|
The C-SSRS is an interview-based rating scale designed to create a topology of suicidal behavior and ideation.
It assesses type of behavior, lethality of suicide attempts, and suicidal ideation, each scored as independent continuous measures.
The C-SSRS is the prospective counterpart to the FDA suicide reclassification analysis and is currently being used in the National Institute of Mental Health (NIMH)funded multi-site trial, Treatment of Adolescent Suicide Attempters (TASA).
The C-SSRS has 26 items
|
baseline, 14 weeks (if attempt made during treatment)
|
Suicide Intent Scale (SIS)
Time Frame: baseline, weekly and 14 week as needed
|
The SIS is a 20-item, interviewer-administered assessment of the intensity of the attempter's wish to die at the time of the index attempt.
Major constructs of the SIS have been found to be predictive both of future suicide attempts and suicide completions.
The SIS has 20 items, and takes approximately 10 minutes to complete.
The SIS is only given at the weekly and post treatment assessments if there has been a suicide attempt since the last assessment.
|
baseline, weekly and 14 week as needed
|
Lethality of Suicide Attempt Rating Scale
Time Frame: baseline, weekly and 14 weeks as needed
|
Lethality of past suicide attempts will be assessed using this 11-item scale that assesses the medical lethality of attempts.
The scale has high inter-rater reliability, excellent six-month test-retest reliability, and evidence of concurrent validity.
The Lethality Scale has 7 items, and takes approximately 7 minutes to complete.
The Lethality Scale is only given at the weekly and post treatment assessments if there has been a suicide attempt since the last assessment.
|
baseline, weekly and 14 weeks as needed
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Guy S. Diamond, PhD, Children's Hospital of Philadelphia
Publications and helpful links
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.
- Diamond GS, Levy S. Bindungsorientierte Familientherapie als ambulante Nachsoge fur Jugendliche nach Suizidversuch. Psychotherapie im Dialog 13: 41-45, 2012.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-006296
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.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Attachment Based Family Therapy
-
Drexel UniversityUnknownBinge-Eating Disorder | Bulimia Nervosa | Other Specified Feeding or Eating DisorderUnited States
-
Pennsylvania Department of HealthChildren's Hospital of Philadelphia; University of Pittsburgh; Lehigh Valley...Terminated
-
Drexel UniversityNational Institute of Mental Health (NIMH)CompletedDepression | Suicide | Family RelationshipsUnited States
-
Children's Hospital of PhiladelphiaCompleted
-
Helse Stavanger HFThe Research Council of NorwayTerminatedDepressive Disorder | Major Depression | Mood DisorderNorway
-
University Hospital, AkershusUniversity of Oslo; Children's Hospital of Philadelphia; Helse Sor-OstTerminatedDepressive Disorder | Major Depression | Mood DisorderNorway
-
University of DelawareSidney Kimmel Cancer Center at Thomas Jefferson University; Helen F. Graham...RecruitingAnxiety | Depressive Symptoms | Parental StressUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...KU Leuven; ZonMw: The Netherlands Organisation for Health Research and Development and other collaboratorsRecruiting
-
Ohio State UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Universitat Jaume IEuropean Social Fund; Generalitat ValencianaCompletedCompassion | Mental Health Wellness 1Spain