Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of 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.