The objective of this study is to adapt and pilot an existing psychological intervention program (SCCIP-ND, mentioned above) to alleviate anxiety and distress and to prevent PTSS in parents of pediatric patients who are receiving stem cell…
ID
Source
Brief title
Condition
- Other condition
- Leukaemias
Synonym
Health condition
beenmergtransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The parents* and child's socio-demographic and clinical data (gender, age,
level of education) will be recorded during the first round of questionnaires
at baseline. Clinical information will include the primary disease and the
nature of treatment given. After the final session, participant satisfaction
with the intervention (both the structure and content) will be recorded through
a short evaluation form.
Several questionnaires will be used to measure the effects of the intervention:
The Pediatric Inventory for Parents (PIP) is a 42-item self-report
questionnaire that measures illness- related parental stress. Each item is
rated on two 5-point Likert-type scales. The first assesses the frequency of
each stressor; the second scale assesses how difficult the issue has been for
the parent in the last week. Adequate internal consistency (α =.80-.96) and
construct validity of the PIP have been reported (Streisand et al., 2001). A
Dutch version has recently been developed by Jantien Vrijmoet-Wiersma (2007, in
preparation).
The Nijmeegse Parental Stress Index, shortened form NOSIK, measures parental
stress associated with raising children in general. The reliability of the
NOSIK lies between .92 and .95. The NOSIK differentiates well between clinical
and non-clinical groups (de Brock et al., 1994) and is widely used (e.g. Thomas
et al., 2004).
The State Trait Anxiety Index (STAI), state and trait version measures both the
transitory emotional condition of stress and the general inclination towards
anxiety of the respondents. Dutch norm group data are available (van der Ploeg
et al., 2000), as well as information about reliability and validity.
Internationally, the STAI is widely used to measure anxiety (e.g. Seligman et
al, 2004)
The General Health Questionnaire (GHQ), 12-item version, is a self-report
measure of psychological symptoms that can be used as a general measure for
psychological distress (Jackson, 2007). The psychometric properties of the
Dutch version of the scale are reported to be highly satisfactory (Koeter and
Ormel, 1991).
The Impact of Events Scale (IES) is a 20 item self-report questionnaire
measuring symptoms of posttraumatic stress, i.e. avoidance and intrusions. The
questionnaire was designed by Horowitz et al. (1979) and is widely used. The
Dutch version shows good validity and reliability (Brom & Kleber, 1985).
The Ziekte Cognitie Lijst, ouderversie (ZCL-O) is an 18-item questionnaire
covering cognitions that parents can have about their child*s illness. There
are three scales: helplessness, acceptance and disease benefits. The
questionnaire was originally developed for adult patients, but adapted for
parents of children with a chronic disease. Psychometric qualities of the
original questionnaire are acceptable (Evers et al., 1998). The parent version
is currently under study.
Assessment will take place two weeks before admittance (T1), one week before
SCT (T2) and six months after discharge (T3).
Secondary outcome
not applicalbe
Background summary
Stem cell transplantation (SCT) in children has become increasingly
sophisticated and as a consequence mortality rates have decreased (Broers et
al., 2000). In addition to a wide range of medical and socio-emotional
stressors associated with a life threatening illness, SCT represents a severe
stressor with possible disruption for the child and the entire family. The
lengthy hospitalization in isolation, the experiences of physical discomfort,
the uncertainty of outcome as well as the fear of death are stressors
associated with this treatment (Pot-Mees, 1989). Furthermore, the children and
their families have to cope with several possible outcomes that may vary from a
cure and normality to chronic graft-versus-host disease (GVHD), relapse, or the
death of their child (Barrera et al., 2000).
Watching one*s child undergo transplantation can be a very traumatic experience
for parents and can potentially lead to the development of long-term
psychological distress responses (Manne et al., 2004, Rini et al., 2004).
Parents may be at risk for emotional problems like anxiety (Barrera et al.,
2000), depression (Manne et al., 2001), posttraumatic stress symptoms like
intrusions and avoidance (DuHamel et al., 2004, Manne et al., 2004) and various
other stress reactions, particularly during the early period from pre-admission
through three weeks post SCT (Phipps et al., 2005, Streisand et al., 2000,
Dermatis & Lesko, 1990). Other researchers have found longer lasting
psychological effects in a percentage of mothers, ranging from 20% of the
mothers who classified for a psychiatric diagnosis 18 months after the
diagnosis of a malignancy in their child (Manne et al., 2004).
Maternal post-SCT anxiety and depression scores have been found to correlate
strongly with their children*s quality of life, as well as with symptom
severity at 6 months post SCT (Barrera et al., 2000). Mothers who are most at
risk are younger and show high levels of anxiety and depressive symptoms at the
time of transplantation (Manne et al, 2003). Mothers who are depressed may not
be able to attend optimally to the needs of their children. They are generally
less affective towards others, have a decreased ability to make decisions and
have a negative perception towards the future (Nelson, 1997).
Until now only one intervention program, aimed at reducing stress in parents of
children undergoing stem cell transplantation, has been piloted (Streisand et
al., 2000). The intervention -scheduled within 1 week of the child*s admission
to the SCT unit- included a one 90-minute session with mothers only, including
three components: education, relaxation and communication. Mothers in the
intervention group reported the use of significantly more intervention
techniques than mothers in the control group. However, there were no
differences in stress levels between the two groups, possibly because the
intervention involved only one session.
Given the scarcity of intervention research in the SCT population, it is
necessary to look at the accomplishments of intervention studies involving
parents of children with cancer. A number of these studies have yielded
positive effects on parent distress and parent adjustment, according to a
recent meta-analysis (Pai et al., 2006). One of the promising intervention
studies was conducted by Anne Kazak et al. (2004, 2005). She designed a
programme called SCCIP-ND (Surviving Cancer Competently Intervention Program),
for parents of newly diagnosed children. The focus of the program is on
understanding how beliefs about cancer and its treatment influence caregivers
and to help family members anticipate on the impact of cancer on the family.
The intervention has been piloted on 38 families (half of which served as a
control group) and is currently delivered to more than 120 parents. First
results are supportive of the value and challenges of developing evidence-based
family interventions in pediatric psychology (Kazak et al., 2005).
Study objective
The objective of this study is to adapt and pilot an existing psychological
intervention program (SCCIP-ND, mentioned above) to alleviate anxiety and
distress and to prevent PTSS in parents of pediatric patients who are receiving
stem cell transplantation.
Research questions to assess feasibility:
1. Acceptability: Is it possible to implement the intervention? Does it seem
relevant and doable? Was the intervention acceptable to the participants?
2. Recruitment and retention: Can a representative sample be recruited? What is
the participant rate and what can be said about dropouts?
3. Time line: can the intervention session take place as planned?
4. Preliminary outcomes: within the context of a small pilot study, what
evidence is there for the likely effects of the intervention on primary
outcomes?
Study design
Pre-test interventie posttest design.
Since more than one year all parents at the SCT-ward are asked to fill in a
booklet of questionnaires (primary outcomes) at three moments in time: two
weeks before admittance (T1), two weeks after SCT (T2) and six months after
discharge (T3).
These parents will serve as the control group.
Starting in june 2008, the inclusion of intervention group parents start: All
parents of children undergoing SCT will be approached one month before
admittance of their child. They will be assessed at the same time points as the
control group parents. There is no randimization; all parents of children with
a malignancy will be included.
Intervention takes place from one week pre-admittance to four months after
discharge.
Intervention
Parents (as couples) will be asked to participate in the study one month before
admittance by the physician. Assessment takes place two weeks before
admittance, 14 days after SCT and six months after discharge. Parents in the
intervention group will receive four psychotherapy sessions. The first session
will be held at home, two weeks prior to admittance. The second session will
take place during the SCT- admission period on day -7 (1 week before the SCT
itself). One month and four months after discharge, parents take part in
sessions 3 and 4 in the outpatient*s clinic. These sessions serve as booster
sessions, which can assist in the maintenance of intervention outcomes (Pai et
al., 2006).
Parents are taught to recognize the strengths and weaknesses of their own
coping strategies and -if necessary- to change their cognitions and behaviour
in order to alleviate stress and decrease anxiety. Psycho-education and
relaxation skills training will also be standard ingredients of the sessions.
Lastly, we will use filmed family discussions of parents that have already been
through the SCT-experience, with the purpose of learning through modelling. The
sessions are manualized and carried out by the research assistant (a trained
junior psychologist) to avoid bias. Training and coaching of the research
assistant will be done by Jantien Vrijmoet, who is specialized in cognitive
behavioural therapy. The manual used in the SCCIP-study of Anne Kazak (intended
for parents of newly diagnosed children with cancer) will be adapted to use in
this specific population. Treatment fidelity is obtained through working with
manualized sessions, and at random audio taping of the sessions.
Study burden and risks
not applicable
Albinusdreef 2
2300 RC Leiden
Nederland
Albinusdreef 2
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Parents of children undergoing SCT with a malignant disease.
Sufficient knowledge of the Dutch language
Exclusion criteria
Parents of children who are no longer eligible for SCT. Children with a relapse, children without an appropriate donor.
Parents of children who die during the transplant period.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL21013.058.07 |