Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child (PBS)
|ClinicalTrials.gov Identifier: NCT00447174|
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : November 3, 2016
|First Submitted Date ICMJE||March 13, 2007|
|First Posted Date ICMJE||March 14, 2007|
|Last Update Posted Date||November 3, 2016|
|Study Start Date ICMJE||January 2007|
|Actual Primary Completion Date||January 2011 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||complicated grief symptom change [ Time Frame: change from pretreatment to 3 month follow-up ]
Inventory of Complicated Grief
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00447174 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||marital adjustment change [ Time Frame: change from pretreatment to 3 month follow-up ]
Dyadic Adjustment Scale
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child|
|Official Title ICMJE||Dyadic Therapy Assessment Among Couples Coping With Traumatic Loss of a Child|
RESEARCH DESIGN AND METHODS
Treatment Manual Development: Psychoeducation, Dyadic Communication in Adversity, Stress inoculation training and skills building, Cognitive processing and restructuring, Exposure through constructive narrative.Reconstruction of a positive future and relapse prevention..
WAIT-LIST CONTROL STUDY Once the treatment manual is developed, we will move immediately into pilot testing of the treatment in bereaved families. The design for this pilot study is repeated measures that compares two groups at three time points of assessment: (pre-treatment, immediately post-treatment, 3 months post-treatment). Although other outcomes will be assessed, the primary outcomes will be a measure of bereavement and a measure of marital adjustment. The three month follow-up results will be compared to the pre-treatment results using an intent-to-treat analysis with the last observation carried forward. As treatment can last from 13 to 16 sessions, the wait-list control group's welfare is of concern. We will use weekly phone conversations to check in with wait-list participants. If they appear to be deteriorating, they will be immediately referred for treatment. Wait-list participants will be offered treatment at the end of the wait-list period. It should be noted that this contact during the wait-list period represents attention provided to wait-list participants, and thus makes our design somewhat conservative. It is the primary purpose of this study to establish preliminary efficacy through investigating effect sizes associated with the treatment, and to develop a treatment manual, and other required tools to conduct a full efficacy trial.
Participants. Participants will be parents living in Israel who have lost a child, are at least 6 months post loss (following Shear), are over the age of 21, can provide informed consent, and score > 30 on the Inventory of Complicated Grief. Subjects meeting these criteria will undergo a structured clinical interview to assess for inclusion and exclusion criteria. Participants will be provided free treatment, and if needed because of income restrictions will be provided with aid to defray transportation costs to the clinic.
Subject Recruitment. We will be using various methods of recruitment, including press as well as working with partnering organizations who deal with parental bereavement , and recruitment through the trained therapists who work in different clinical settings.
Assessor Training. Assessors will be trained on all measures They are psychometric measures and will be used as specified in the manuals that pertain to their use.
Independent Assessment. Assessors will be kept unaware of what treatment condition the person is in.
Demographics and Bereavement History. In addition to standard demographic information, we will obtain detailed information about the circumstances surrounding the child's death .
Psychiatric History. Axis I disorders will be assessed using the Structured Clinical Interview for DSM-III-R (SCID-1).The SCID is a semi-structured interview commonly used in research settings to assess a subject's psychiatric history. Bereavement. Adaptation to bereavement will be measured using the Inventory of Complicated Grief (ICG).This is a 19 item self report measure of maladaptive symptoms of loss as described by the authors. Responses are given on a Likert scale.
PTSD. PTSD will be measured with both a clinician administered measure (CAPS) and a self-report measure (PDS).The CAPS is a 30 item interview that provides a diagnosis of PTSD based on all 17 symptoms of the DSM-IV defined disorder including frequency and intensity of symptoms. It also provides a measure of the impact of the symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, the patient's global improvement since baseline, and the validity of ratings obtained.
Depression. Depression will be measured with the SCID-I32 (described above) and the Beck Depression Inventory (BDI- II). The BDI (and subsequently, the BDI-II) is the most widely used instrument for measuring the severity of depression and a `gold standard' among self-report measures of depression. It is a 21-item scale, with possible scores ranging from 0 to 63 (higher values correspond to higher depressive symptomatology).
Suicidality. Will be assessed with the Beck Scale for Suicide Assessment (BSS). This is a 21-item self-report instrument measuring the presence and severity of suicide ideation. Similar in format to the BDI, each item consists of three statements ranked in intensity from 0 to 2 Marital Impairment. The quality of adjustment in the marital relationship will be measured using the Dyadic Adjustment Scale (DAS). This 32 item measure is widely used in clinical and research settings and consists of four subscales: Dyadic Consensus, Dyadic Satisfaction, Dyadic Cohesion and Affectional Expression.
Social Impairment. Impairment in social functioning will be measured using the Social Adjustment Scale-Self Report which provides scores in the following domains: work, social and leisure activities, relations with extended family, primary relationship, parenthood, family life and economic.
Treatment Procedures. Referred persons will be screened and if they meet criteria will be matched as noted above for randomization. If persons do not meet criteria they will be referred for alternative treatment or to the community. Assessments will be conducted by our assessor/outreach coordinator. Each case will be reviewed at a consensus conference chaired by the PI.
Suicidal ideation and plans will be clinically assessed throughout the treatment protocol. Any participant identified at increased risk because of suicidal ideation will be monitored closely. A clinical consensus conference will be held and additional treatment will be recommended and provided as needed.
Treatment Fidelity. Treatment sessions will be audiotaped. Treatment fidelity raters will be trained to an 85% reliability level. Twenty-five percent of sessions will be randomly reviewed (stratifying for session number) and rated for adherence to protocol. Ten percent of sessions will be rated by a second rater to insure that reliability is maintained, guarding against rater drift.
DATA ANALYSES The design is a repeated measures (pre-treatment, post-treatment, 3 month follow-up) comparison of intervention and wait-list control conditions. We will assess treatment efficacy by examining the change from pre-treatment to the three-month follow-up score using an intent-to-treat analysis (carrying last observation forward). To avoid the loss of power associated with testing many hypotheses, we have selected a-priori as primary outcomes to be analyzed (1) complicated grief symptoms (ICG) and (2) marital adjustment. An analysis of change scores is equivalent to a repeated measures analysis comparing only baseline to three-month follow-up. For each outcome measure, an analysis of covariance using a change score will compare the intervention and wait-list conditions, controlling for the baseline score on the measure.
HUMAN SUBJECTS RESEARCH Sources of Data Baseline assessments will include demographic data, psychiatric history, current psychiatric diagnoses, description of the death of the child, relationship information, and social functioning information. Only staff working on the parental bereavement project will have access to subject identities. Any identifying subject data will be stored separately from the rest of the data. All data will be collected through in-person interviews and self-report questionnaires. All interviews will be videotaped for treatment adherence factors. This data will be collected specifically for this research project.
Potential Risks The principal risks for subjects participating in this study include possible emotional distress as they recall the painful story of the death of their child. The goal of the present clinical trial is to alleviate emotional distress on a long-term basis. It is also possible that subjects randomized to the wait-list control will have a deterioration of symptoms prior to participating in the research protocol. We will monitor this through weekly 15-minute phone check-ins to assess psychiatric status. Immediate treatment referral will be provided in the event of deterioration.
Recruitment and Informed Consent A referral system will be set-up through area churches and synagogues, parental bereavement support groups, different departments in Mt. Sinai Hospital (e.g. pediatrics, oncology, emergency medicine, etc), area funeral homes and Sloan Kettering Memorial Hospital. Members of the parent bereavement referral network will be provided with detailed descriptions of the program. Informed consent will be obtained in person after the research clinician presents a description of the treatment as well as the regulations regarding informed consent. They will be provided with written documentation of the above information. Ample time will be provided for potential subjects to ask questions. When it is clear that they understand the purpose of the study and the process of informed consent, they will be asked to sign and date the consent form if they agree to be in the study.
Protection of Subjects Well-Being While bereavement treatment research to date has shown no harm to subjects and some benefit, a system of monitoring the well being of participants will be put into place including the following procedures:
Protection of Data Any identifying subject data will be stored separately from all other patient data. While stored separately, both sets of data will be stored in a locked cabinet which will be in a locked room. Scientific presentations and publications will not use subject names and will only use aggregate data. Data entry will be done twice and compared to establish accuracy. After entry, data will be checked for variable ranges and internal consistency using SPSS.
Data and Safety Monitoring Plan A DSMB will be established to monitor the project. In addition, during all phases of the project, data collection will be monitored monthly by the PI through individual supervision, project team meetings and random review of session audiotapes and written transcripts. Monthly reports will be generated noting any problems encountered in treatment and the drop out of any participants. Any adverse events that occur during consent or treatment phases will be reported immediately to the PI. Adverse events will also be reported to the IRB and the NIH. Specifically, all serious adverse events associated with the study procedures, and/or any incidents involving the conduct of the study or patient participation, including problems with the consent processes will be reported. Summaries of safety and study performance information from reports will be provided to the IRB at the Mt. Sinai School of Medicine.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Condition ICMJE||Bereaved Parents|
|Intervention ICMJE||Behavioral: Dyadic treatment for parental bereavement|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||January 2012|
|Actual Primary Completion Date||January 2011 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||21 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00447174|
|Other Study ID Numbers ICMJE||BromD1CTIL|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Herzog Hospital|
|Study Sponsor ICMJE||Herzog Hospital|
|Collaborators ICMJE||Icahn School of Medicine at Mount Sinai|
|PRS Account||Herzog Hospital|
|Verification Date||November 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP