Care for Post-Concussive Symptoms

Concussion Clinical Trial

— CARE4PCS  

Official title:

Care for Post-Concussive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268240
• Other study ID #: RS_CARE4PCS
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: September 2018
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• Between ages 11 and 18

• Have sustained a head impact during sports participation

• Have incurred an onset or increase of at least three post-concussive symptoms following head impact

• Have increased post-concussive symptoms following head impact have continued for at least 4 weeks

• Live with their parents or legal guardians

• Live within commuting distance of Seattle Children's Hospital

• Willing to participate in assessment and treatment

• Have at least one parent/caregiver willing to participate in assessment and treatment

Exclusion Criteria:

• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder

• Active suicidality

• Substance dependence

Related Conditions & MeSH terms

• Concussion
• Post-Concussion Syndrome

Intervention

Behavioral:
• Stepped Care
Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.

Locations

Country	Name	City	State
United States	Seattle Childrens Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Concussion Symptoms	Health Behavior Inventory Assessment	At enrollment, 1 month, 3 months, and 6 months
Primary	Change in Depressive Symptoms	PHQ-9	At enrollment, 1 month, 3 months, and 6 months
Primary	Change in Anxiety Symptoms	PROMIS A-8	At enrollment, 1 month, 3 months, and 6 months
Primary	Change in Quality of Life	PedsQL	At enrollment, 1 month, 3 months, and 6 months
Secondary	Change in School Functioning	Attendance and Grades	At enrollment, 1 month, 3 months, and 6 months
Secondary	Change in Family Functioning	FAD-GF	At enrollment, 1 month, 3 months, and 6 months
Secondary	Change in Parent Anxiety Symptoms	PROMIS A-8	At enrollment, 1 month, 3 months, and 6 months
Secondary	Change in Parent Depressive Symptoms	PHQ-9	At enrollment, 1 month, 3 months, and 6 months
Secondary	Change in ImPACT Assessment	ImPACT test scores	At enrollment and 6 months
Secondary	NIH Toolbox - Dimensional Card Sort Test	Dimensional Card Sort Test scores	At enrollment and 6 months
Secondary	Change in NIH Toolbox - Picture Memory Sequence Test	Picture Memory Sequence test scores	At enrollment and 6 months
Secondary	Change in King-Devick Test	King-Devick Test scores	at enrollment and 6 months