Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child
Condition: Bereaved Parents
Study type: Interventional

Summary: 
      1. Develop a treatment for clinically significant parental bereavement. The proposed
           treatment development activities include:

             1. Development of a treatment manual, associated fidelity rating forms, and training
                aids,

             2. Pre-testing the treatment manual with bereaved parents, and revision in
                consultation with treatment development experts,

        2. Conduct a randomized, wait-list control, pilot study of the proposed treatment:

             1. Measure treatment-related change in (a) complicated grief symptoms, the primary
                outcome variable, which will be assessed using the Inventory of Complicated Grief,
                and, (b) marital adjustment, the secondary outcome measure, to be assessed using
                the Dyadic Adjustment Scale. These outcomes will be assessed in treatment and
                control groups at baseline, at treatment conclusion, and at three month follow-up.

             2. Test the difference between the treatment and control groups on changes from
                baseline to three month follow-up on the exploratory outcome variables of PTSD,
                depression, social and work impairment, and quality of life

             3. Estimate effect sizes of these differences in changes in outcomes

        3. Develop a proposal for a randomized controlled trial of the treatment, based on the
           results of aim 2.
    

Detailed description: 
      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:

        -  All clinicians providing the manualized treatment will be licensed and trained in the
           techniques being applied.

        -  Prior to beginning the treatment protocol, intensive training and practice of the
           manualized treatment will be provided through formalized training sessions for all
           clinicians.

        -  Ongoing supervision will be provided throughout the duration of the treatment

        -  Patients randomized to the wait-list control will be monitored through weekly phone
           conversations.

        -  Referrals for any participants (focus groups, interviews, wait-list control study
           participants, family members involved in treatment) can be made for emergency or other
           inpatient or outpatient psychiatric services at Mt Sinai School of Medicine.

      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.
    

Intervention name(s): Dyadic treatment for parental bereavement
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Grief; parental bereavement