Clinical trial NCT01603563: Stepped Care for Young Children After Trauma
Official title: Stepped Care for Young Children After Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: Stepped Care
Trauma-Focused Cognitive Behavioral Therapy
Preschool children
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this R34 study is to develop and test the feasibility of a Stepped Care intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures, treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al., 2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the effectiveness of SC-TF-CBT for early childhood PTSD.

Detailed description: Young children who are exposed to traumatic events such as abuse, disasters, accidents, illnesses, injury and the death of a person close to them are at risk for developing PTSD. While effective treatments for childhood PTSD exist, novel interventions that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The purpose of this study is to develop and test the feasibility of an intervention called Stepped Care Trauma-Focused Cognitive Behavioral Therapy which has the potential to greatly improve service delivery approaches to make treatment more accessible and less costly, thereby reducing childhood PTSD and related societal impacts and costs.

Eligibility criteria: Inclusion Criteria:

1. Child must have experienced at least one traumatic event after the age of 36 months.
2. At least five Postttraumatic stress symptoms with one symptom of reexperiencing or one symptom of avoidance.
3. Child must be between 3 and 7 years of age at the time of enrollment.
4. The parent must be willing and able to participate in the treatment and complete informed consent.

Exclusion Criteria:

1. Psychosis, mental retardation, autism, or related pervasive developmental disorders in child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions.
2. Parent has had substance use disorder within the past 3 months.
3. Child or parent is suicidal (the DIPA will be used to screen for child suicidal ideation and the SCID-RV will be used to screen for parent suicide ideation; assessed by all available information). A delayed entry once the parent or child is stabilized (at least 6 months post suicidal) and not having suicidal ideation will be allowed.
4. Child or parent is not fluent in English.
5. Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.
6. Child is receiving trauma-focused psychotherapy when study treatment is provided.
7. Parent or caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home (e.g. mother's boyfriend, sibling).

Primary outcomes:
measure: Posttraumatic stress symptoms
timeFrame: baseline, week 14, and 3 month follow up
Secondary outcomes:
measure: Externalizing behaviors
timeFrame: baseline and week 14 and 3 month follow up
measure: Internalizing behaviors
timeFrame: baseline, week 14 and 3 month follow up
measure: Independent Evaluator-rated PTSD symptom and impairment severity
timeFrame: baseline, week 14 and 3 month follow up
measure: Global improvement
timeFrame: baseline, week 14 and 3 month follow up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Crisis Center of Tampa Bay
state: Florida
Study officials:
affiliation: University of South Florida
name: Alison A Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salloum A, Wang W, Robst J, Murphy TK, Scheeringa MS, Cohen JA, Storch EA. Stepped care versus standard trauma-focused cognitive behavioral therapy for young children. J Child Psychol Psychiatry. 2016 May;57(5):614-22. doi: 10.1111/jcpp.12471. Epub 2015 Oct 7.