Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447174
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2007-03-13
Brief Title:
Parental Bereavement Study Among Couples Coping Traumatic Loss of a Child
Sponsor:
Herzog Hospital
Organization:
Herzog Hospital
Study Overview
Official Title:
Dyadic Therapy Assessment Among Couples Coping With Traumatic Loss of a Child
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBS
Brief 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
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 narrativeReconstruction 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 groups 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 childs death
Psychiatric History Axis I disorders will be assessed using the Structured Clinical Interview for DSM-III-R SCID-1The SCID is a semi-structured interview commonly used in research settings to assess a subjects psychiatric history Bereavement Adaptation to bereavement will be measured using the Inventory of Complicated Grief ICGThis 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 PDSThe 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 patients social and occupational functioning the overall severity of the symptom complex the patients 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 assessoroutreach 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 eg 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 andor 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
Treatment Manual Development Psychoeducation Dyadic Communication in Adversity Stress inoculation training and skills building Cognitive processing and restructuring Exposure through constructive narrativeReconstruction 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 groups 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 childs death
Psychiatric History Axis I disorders will be assessed using the Structured Clinical Interview for DSM-III-R SCID-1The SCID is a semi-structured interview commonly used in research settings to assess a subjects psychiatric history Bereavement Adaptation to bereavement will be measured using the Inventory of Complicated Grief ICGThis 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 PDSThe 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 patients social and occupational functioning the overall severity of the symptom complex the patients 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 assessoroutreach 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 eg 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None