Prevention of Postpartum Traumatic Stress (PTSD) in Mothers With Preterm Infants.

There are three phases to this research study:

1. DEVELOPMENT OF A TREATMENT MANUAL TO HELP REDUCE PSYCHOLOGICAL DISTRESS IN PARENTS OF
NICU INFANTS.

We currently have pilot data on a three session intervention designed to reduce
psychological distress in NICU parents. In this phase of hte study, we plan to augment
this intervention by adding an additional three sessions for a total of six sessions
which will comprise our new treatment manual. To accomplish this, we will conduct a
comprehensive review of the content of all current empirically based cognitive behavior
therapy (CBT) treatments for PTSD, abstract the key elements, compare the key elements
with our current treatment for PTSD and construct a fourth session using a combination
of Stress Inoculation Training techniques (including relaxation training, thought
stopping, cognitive restructuring) and imaginal re-exposure. A similar process will be
used to identify parent-child interventions currently available used with premature or
other vulnerable young children. The redefinition of the infant and reeducation of the
mother to promote sensitivity toward and attachment with the infant are likely topics.

2. PILOT THE MANUALIZED TREATMENT IN AN OPEN TRIAL WITH 10 NICU MOTHERS, SOLICIT FEEDBACK
AND MODIFY INTERVENTION SESSIONS.

To obtain clinically relevant feedback and prepare for any unforeseen logistical
issues, we will pilot the six session treatment intervention in 10 mothers whose
newborns are hospitalized in the LPCH NICU. The recruited parents will be
representative of the population of mothers that the intervention is intended
for-English and Spanish speaking mothers of infants >= 28 weeks, over 1000 grams, born
at LPCH or transferred within 72 hours with CRIB scores, a measure of medical severity,
of 15 or less. Children transferred for cardiac surgery and those with congenital
abnormalities will not be eligible. Mothers will be approached by a member of the NICU
staff within 72 hours of the infant's admission to the NICU. The mother will be given
an information sheet about the project and invited to speak with the study coordinator.
Potential subjects who give informed consent will complete the three screening
instruments, the Stanford Acute Stress Reaction Questionnaire (SASRQ), Beck Anxiety
Inventory (BAI) and Beck Depression Inventory-I (BDI I) and the sociodemographic
questions.

Within 48 hours, one of the study psychologists, will contact enrolled mothers,
establish a schedule for the 6 sessions and initiate the course of treatment. The
sessions will be individual and held at a time and location convenient for the mother.
We expect that most sessions will be in the LPCH NICU in private offices suitable for
therapy sessions. Should the infant be discharged from the NICU prior to the 6th
session, the remaining sessions will be scheduled at home, LPCH or the Department of
Psychiatry. Following the 6th session, the mothers will be contacted by the study
coordinator who will administer the instruments chosen for the post intervention
assessment and assess satisfaction with the treatment sessions. Specific questions
will include: What did you like/dislike about the treatment?; Which sessions were
most/least helpful?; Could the treatment be structured differently?; Was the
timing/length of the sessions appropriate?; Were the techniques taught useful?; How
satisfied were you with this intervention? All evaluation materials including changes
in pre/post scores on our instruments will be summarized and presented to our
Scientific Advisory Group. Once consensus is reached on the revised manual, the manual
will be rewritten to incorporate feedback and data obtained in the pilot study.

3. CONDUCT A RANDOMIZED TRIAL OF THE TREATMENT INTERVENTION COMPARED TO AN INFORMATION,
USUAL CARE, SUPPORT CONTROL CONDITION.

Eligible mothers (N=100) will be randomly assigned to receive either: (1) the manual driven,
CBT-based trauma focused plus mother redefinition/education intervention; or (2)
information, usual care/support. The intervention is expected to last 3 weeks with two
45-55 minute sessions weekly. Participants in both conditions will be assessed at baseline,
within one week after the completion of the intervention or at 4-5 weeks for the control
group and at 6-months post-baseline.

The information/usual-care/support condition was chosen to control for possible symptom
changes due to routine clinical contacts common in the NICU, the effect of time, the effect
of attention and any effects due to repeated assessments. Parents in the information/usual
care/support group will receive one 45 minute information session on the policy, procedures
and environment of the NICU by a Neonatal Nurse Practitioner (Table 4). We have chosen to
use a Nurse Practitioner for the information comparison because this is a role they often
assume at LPCH. This session is based on an LPCH Hospital Information Packet that is
routinely distributed to all NICU parents, although generally without any instruction or
face-to-face review of its content. Women in this group will be followed up by telephone or
in the NICU one week after the information session to answer any questions that they may
have. In addition, mothers will be referred to the existing parent mentor program for
support and coping strategies. By adding the parent mentor support we expect that the
contact will be similar to the intervention group and, thus, will approximate an
attention-matched comparison condition. Mothers in this group will also receive the care
that is typical for NICU parents including contacts with nurses, physicians, social workers,
chaplaincy and developmental psychologists.

Thirty of the participants in the intervention arm will be randomized to receive an expanded
intervention of 6 additional sessions (sessions 7-12). These sessions will elaborate on the
themes identified in Session 4 and follow the current models of PTSD treatment that
generally provide a minimum of 12 sessions. These sessions will likely use cognitive
restructuring to address distortions about the NICU experience. Specific issues explored
will be individualized to each parent but may include parental guilt, parental anxiety about
their infant's medical health, and difficulties related to the perceived absence of a
parental role. There will also be a strong emphasis on the use of stress inoculation
training to assist parents in developing strategies to manage trauma symptoms. The 30
participants in the intervention arm who are not randomized to the expanded intervention
will be offered contact with the existing parent mentor program. Parent mentors offer
support, coping strategies and suggestions on how to normalize life after the NICU
hospitalization. Should an infant die, the mother will be disenrolled from the study and
assisted with a referral for conventional mental health support services.

Inclusion Criteria:

English and Spanish-speaking mothers greater than 18 years of age of infants in the LPCH
NICU >=26 weeks of gestation are eligible for screening.

Exclusion Criteria:

1. Mothers of children awaiting cardiac surgery, those who have congenital abnormities
and those who are unlikely to survive, will be excluded.

2. Mothers of NICU infants who are found on their routine clinical psychosocial
evaluation to be at high psychiatric risk (i.e., those with either psychotic symptoms
or suicidal or infanticidal ideation) will also be excluded. These parents, however,
will be referred for and receive appropriate mental health intervention.

3. Mothers who do not speak English or Spanish, or who do not have the ability to
understand the questionnaires will be excluded.

4. Mothers who have active and current symptoms of suicidal ideation, or psychotic
symptoms (delusions or hallucinations) as identified by self report or following a
diagnostic interview will be excluded from the study, but will also be referred for
emergency psychiatric evaluation.