Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00447252 |
| Other study ID # |
Brom2CTIL |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 1
|
| First received |
March 13, 2007 |
| Last updated |
March 13, 2007 |
| Start date |
January 2007 |
Study information
| Verified date |
March 2007 |
| Source |
Herzog Hospital |
| Contact |
Danny Brom, Ph.d |
| Phone |
+972-2-6449666 |
| Email |
dbrom[@]herzoghospital.org |
| Is FDA regulated |
No |
| Health authority |
Israel: Ministry of Health |
| Study type |
Observational
|
Clinical Trial Summary
The present study will focus on several objectives in the framework of the family
perspective and systemic understanding of the mourning process:
1. Identification of the psychological, social and practical needs of families that have
lost a child to terrorism.
2. Deepening and extending the knowledge of how families cope with the loss of a child in
a violent incident of a security-related nature.
3. Identification of risk and resilience factors within the family structure, and the
nature of the relationships within the family.
Description:
Assessment of Families Who Have Undergone the Traumatic Loss of a Child Study Protocol
The present study will focus on several objectives in the framework of the family
perspective and systemic understanding of the mourning process:
1. Identification of the psychological, social and practical needs of families that have
lost a child to terrorism.
2. Deepening and extending the knowledge of how families cope with the loss of a child in
a violent incident of a security-related nature.
3. Identification of risk and resilience factors within the family structure, and the
nature of the relationships within the family.
The University of Al-Quds in East Jerusalem will be conducting an identical study in
conjunction with this one, examining Palestinian families who have lost a child in the
conflict with Israel. Collaboration between these studies will allow a cross-cultural
comparison of family coping with traumatic loss, and of the identification of resilience and
risk factors among the families.
Method of the study Participants. The assessment process will include some twenty-five
Israeli families who have lost a son or daughter below the age of 18 as a result of a
terrorist incident, at least six months previously. All family members living at home will
participate in the study. The study will not include single-parent families, or family
members who suffer from mental retardation, disturbances because of addiction, or
psychiatric disturbance from the psychotic or autistic spectra (schizophrenia,
manic-depressive illness, psychotic disturbances, PDD).
Procedure. The recruitment of families will be done by the Kobi Mandel Foundation, which is
involved in helping families that have been victims of terror. The Foundation will not
approach families who fit the criteria of ineligibility for the study, as described in the
previous paragraph. The parents will fill out a form of informed consent on their own
behalf, and on behalf of their children who are under the age of 18, after they have
received an explanation about the procedure of the study, and have been given an opportunity
to ask questions about it. Teenagers over 14 years old will sign a form of informed consent,
with parental permission. Family members over the age of 18, living at home, will fill out a
form of informed consent on their own behalf.
To carry out this stage, each family will be assigned a professional by the Israel Center
for the Treatment of Psychotrauma, who will be its liaison and responsible for the process
of assessment. The completion of the questionnaires will be coordinated with the family
members, and carried out in the presence of the liaison, who will assist in explaining the
questionnaire, and provide support in the event of emotional difficulties arising.
Every member of the family will fill out the questionnaire separately; the liaison will
focus on helping children who have difficulty doing so. The parents will fill out
questionnaires for small children (under 10 years old). In order to preserve the privacy of
the participants, each family member will receive a personal code to be written on the
questionnaire. The liaison alone will have the key to identify each participant, which is
important for the identification of needs within the family, and the ability to direct them
for appropriate treatment.
Possible risks. The main risk for the participants relates to the possible uncomfortable
feeling the questionnaire might raise by evoking memories of the deceased, and to personal
distress. For this reason, the questionnaires will be given to the participants by a trained
professional who will be able to provide support, identify distress and suggest seeking
professional treatment if necessary.
Qualifications of the Principal Investigators. The work will be carried out under the
supervision of Dr. Danny Brom, the founder and current director of the Israel Center for the
Treatment of Psychotrauma.
Description of the research instruments Demographic and organizational details. The
participants will relate to demographic details like age, sex, family status, place in the
family, occupation and socio-economic status, as well as information about the death
(circumstances and time of death, description of the loss).
McMaster Family Assessment Device (FAD): This questionnaire contains 60 self-reported items
that assess six aspects of family functioning: Problem solving, Communication, Roles,
Affective responsiveness, Affective involvement, Behavior control In addition, the
questionnaire contains a component (12 items) of general functioning (Epstein, Baldwin and
Bishop, 1983).
Couple adjustment: Dyadic Adjustment Scale (DAS) (Spanier, 1976). The quality of mutual
adjustment in the marital system will be measured by the DAS questionnaire, which contains
32 items in four subscales: Dyadic Consensus, Dyadic Satisfaction, Dyadic Cohesiveness and
Affectional Expression.
Adults Grief Response: Inventory of Complicated Grief – ICG (Prigerson and Jacobs, 2001).
The questionnaire examines adjustment to grief. Its 33 items measure non-adaptive symptoms
of response to loss. The items make up two primary distress scales – traumatic distress and
separation distress – which represent a uni-dimensional construct. The participants are
asked to grade the degree to which they experience each of the symptoms presented, on a
Likert scale of 1 (never) to 5 (always).
Exposure to trauma and post-traumatic distress. The PDS questionnaire (Foa, Feske & Murdock,
1993) will examine the history of traumatic events, subjective trauma response,
post-traumatic symptoms and functional impairment. The questionnaire includes yes/no
questions for the parent to answer regarding possible traumas in his or her past. Four
yes/no questions examine the subjective response to the event (criterion A2). The section
that examines post-traumatic symptoms includes 17 items that relate to the appearance of
different symptoms, according to DSM, within the last month: re-experiencing the event
(criterion B), avoidance (C) and hyperarousal (D). The scale of responses runs from 0 (not
relevant or happened only once) to 3 (almost all the time). A grade of 2 or more is regarded
as verifying the existence of a symptom.
Beyond this, the questionnaire contains nine yes/no questions that relate to impaired
functioning in different areas of life, like work, relations with family members, leisure
time activity, and so on.
Depression: Beck Depression Inventory (BDI-II). This widely accepted questionnaire measures
the severity of symptoms of depression. It was updated in 1996 in order to meet the criteria
of the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition). The
participants are asked to relate to 21 items that describe different depressive symptoms on
a scale of 0-3. A general score on the questionnaire can therefore lie between 0 and 63 (a
higher score indicates greater severity of depressive symptoms).
Adolescents Grief response: UCLA Trauma Psychiatry Service Grief Inventory (Layne et al,
1998). On this questionnaire, the participants are required to answer ten items that relate
to loss response, from 0 (not at all) to 4 (very much) on a Likert scale.
Post-traumatic symptoms. UCLA PTSD Reaction Index Adolescent Version (RI-R) (Rodriguez,
Steinberg, & Pynoos, 1999). The RI-R is a new version of the earlier UCLA Reaction Index
(Frederick, Pynoos, & Nader,1992), which was based on the DSM-III. The RI-R includes 22
items for self-report. It measures the frequency of post-traumatic symptoms in the previous
four weeks. Subject are asked to note the frequency of symptoms on a scale from 0 (never) to
4 (most of the time). The measure of the severity of post-traumatic symptoms will be
computed by summarizing 20 items on the questionnaire, as per Rodriguez et al (1999).
Functional impairment. This will be measured by means of items on the Diagnostic Predictive
Scale (DPS), which relates to significant impairment in different areas of functioning (APA,
2000), for example: functioning in school, social relations, family relations, activity
outside school and dangerous behavior. The participants will be asked to grade, on a scale
of 0 (not at all) to 5 (very much) the degree to which they have experienced impairment in
functioning in these areas. The severity of functioning impairment will be computed as the
sum of all the items.
Exposure to traumatic events. This self-report questionnaire is a translation of the
questionnaire by Ford et al. (1997), and works on the same basis. The subjects will be asked
to answer, yes or no, whether they were ever exposed to one or more of 17 different
traumatic events .
Strengths and difficulties. The Strength and Difficulties Questionnaire (SDQ), self-reported
or filled out by parents, contains 25 items which assess different aspects of adjustment
among children and adolescents focusing on behavioral symptoms. The questionnaire is
intended to be completed by parents (or teachers) for children aged 3-16. Adolescents aged
11-16 can fill out the questionnaire by themselves (Goodman, 1997). The participants are
asked to relate to 25 positive and negative statements, and respond as to what degree each
statement fits their children, on a Likert scale of 1 (not true) to 3 (certainly true). The
questionnaire is made up of five main factors: emotional symptoms, behavioral problems,
attentiveness and hyperactivity, relations with the peer group, and pro-social behavior.
Children (Grades 3-6) Depression. Children Depression Inventory (CDI) (Kovacz, 1992) is a
self-report questionnaire that assesses cognitive, affective, somatic and behavioral aspects
of depression in children and adolescents from age 6 to 17. The original version of the
questionnaire has 27 items, each containing three sentences. The child needs to choose the
sentence that best describes his feelings over the previous two weeks. The scoring of the
questionnaire presents a general score and five sub-scores: negative mood, interpersonal
problems, ineffectiveness, anhedonia and self-image.
Anxiety. The Screen for Child Anxiety Related Emotional Disorders (SCARED), (Birmaher et al,
1997) is a self-report questionnaire that assesses anxiety symptoms in children. A general
anxiety measure (eight items) and a separation anxiety measure (seven items) will be
computed from the questionnaire. The subjects will be asked to grade, on a scale from 0
(generally not true) to 2 (generally true), the degree to which the items describes their
situation. The general score on the two scales will be computed as the sum of the items.
Small children The report on the distress of small children in the family will be divided
into two. For children aged 2-11, the parents will answer SDQs. For children aged 2-5, the
parents will answer the Post-traumatic Stress Questionnaire. Each parent will answer a
separate questionnaire.
Post-traumatic stress. The questionnaire is based on a semi-structured interview with the
parents with respect to post-traumatic symptoms in their little children (ages 2-5)
(Scheeringa & Zeanah, 1994). The parents will be asked to mark, on a scale of 0 (never) to 3
(yes), whether each one of the symptoms were evident in their children within the previous
month.
