NCT01307293

Brief Summary

The purpose of the study includes:

  1. 1.To develop a treatment manual and pilot test this treatment intervention which is designed to prevent and reduce psychological distress in parents who have infants hospitalized in the neonatal intensive care unit (NICU).
  2. 2.To conduct a treatment intervention study in which parents of NICU infants will receive a 6-12 session treatment designed to reduce psychological distress, and to compare outcomes with parents who do not receive the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

February 28, 2011

Last Update Submit

November 18, 2014

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

  • Davidson Trauma Scale

    6 months

  • BDI-II

    6 months

Secondary Outcomes (1)

  • CAPUTE

    6 months

Study Arms (2)

Cognitive Behavior Therapy

EXPERIMENTAL

6-12 sessions of Cognitive Behavior Therapy to address PTSD symptoms and parenting issues related to premature infants.

Behavioral: Cognitive behavior therapy

Placebo comparison

NO INTERVENTION

Education regarding NICU parenting issues.

Interventions

Cognitive behavior therapyBEHAVIORAL

6 or 12 sessions of cognitive behavior therapy.

Cognitive Behavior Therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Mothers of children awaiting cardiac surgery, those who have congenital abnormities and those who are unlikely to survive, will be excluded.
  • 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.
  • Mothers who do not speak English or Spanish, or who do not have the ability to understand the questionnaires will be excluded.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (3)

  • Shaw RJ, St John N, Lilo E, Jo B, Benitz W, Stevenson DK, Horwitz SM. Prevention of traumatic stress in mothers of preterms: 6-month outcomes. Pediatrics. 2014 Aug;134(2):e481-8. doi: 10.1542/peds.2014-0529.

    PMID: 25049338RESULT

  • Shaw RJ, St John N, Lilo EA, Jo B, Benitz W, Stevenson DK, Horwitz SM. Prevention of traumatic stress in mothers with preterm infants: a randomized controlled trial. Pediatrics. 2013 Oct;132(4):e886-94. doi: 10.1542/peds.2013-1331. Epub 2013 Sep 2.

    PMID: 23999956RESULT

  • Horwitz SM, Storfer-Isser A, Kerker BD, Lilo E, Leibovitz A, St John N, Shaw RJ. A model for the development of mothers' perceived vulnerability of preterm infants. J Dev Behav Pediatr. 2015 Jun;36(5):371-80. doi: 10.1097/DBP.0000000000000173.

    PMID: 25961903DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Richard J Shaw

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Sarah McCue Horwitz

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 2, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(1)