Family Therapy as Hospital Aftercare for Adolescent Suicide Attempters
This study has been completed.
Sponsor:
Children's Hospital of Philadelphia
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01195740
First received: September 3, 2010
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
Few empirically-based treatment models exist for adolescent suicide attempters post psychiatric hospitalization, despite the fact that managed care has limited the role of hospitalization to stabilization, rather than remission. This study will test the efficacy and initial outcomes of Attachment Based Family Therapy (ABFT) as an aftercare model to further gains made in inpatient treatment and reduce risk factors for future suicide attempts.
| Condition | Intervention | Phase |
|---|---|---|
|
Suicide Ideation Depression Family Conflict |
Behavioral: Attachment Based Family Therapy Behavioral: Enhanced Usual Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Family Therapy as Hospital Aftercare for Adolescent Suicide Attempters |
Resource links provided by NLM:
Further study details as provided by Children's Hospital of Philadelphia:
Primary Outcome Measures:
- Client Satisfaction Questionnaire (CSQ) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]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
- Cornell Services Index (CSI) [ Time Frame: baseline, 14 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Beck Depression Inventory (BDI) [ Time Frame: baseline, weekly, 14 weeks ] [ Designated as safety issue: No ]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.
- Relatedness Scale (RS) [ Time Frame: baseline, 14 weeks ] [ Designated as safety issue: No ]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.
- Relationship Structures Questionnaire (RSQ) [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]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.
- Suicide Ideation Questionnaire (SIQ-JR) [ Time Frame: baseline, weekly, 14 weeks ] [ Designated as safety issue: Yes ]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.
- Columbia Suicide-Severity Scale (C-SSRS) [ Time Frame: baseline, 14 weeks (if attempt made during treatment) ] [ Designated as safety issue: Yes ]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
- Suicide Intent Scale (SIS) [ Time Frame: baseline, weekly and 14 week as needed ] [ Designated as safety issue: Yes ]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.
- Lethality of Suicide Attempt Rating Scale [ Time Frame: baseline, weekly and 14 weeks as needed ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 20 |
| Study Start Date: | July 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Attachment Based Family Therapy |
Behavioral: 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:
|
| Active Comparator: Enhanced Usual Care |
Behavioral: 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.
Other Name: Enhanced Usual Care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195740
Locations
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Children's Hospital of Philadelphia
American Foundation for Suicide Prevention
Investigators
| Principal Investigator: | Guy S. Diamond, PhD | Children's Hospital of Philadelphia |
More Information
No publications provided
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01195740 History of Changes |
| Other Study ID Numbers: | 08-006296 |
| Study First Received: | September 3, 2010 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Philadelphia:
|
Suicide Ideation Depression Family Conflict |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Suicide Behavioral Symptoms |
Mood Disorders Mental Disorders Self-Injurious Behavior |
ClinicalTrials.gov processed this record on May 16, 2013