Care for Post-Concussive Symptoms

NCT02268240 | Completed

• 1 other identifier: RS_CARE4PCS
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion

Outcome Measures

Primary Outcomes (4)

• Change in Concussion Symptoms

  Health Behavior Inventory Assessment

  At enrollment, 1 month, 3 months, and 6 months

• Change in Depressive Symptoms

  PHQ-9

  At enrollment, 1 month, 3 months, and 6 months

• Change in Anxiety Symptoms

  PROMIS A-8

  At enrollment, 1 month, 3 months, and 6 months

• Change in Quality of Life

  PedsQL

  At enrollment, 1 month, 3 months, and 6 months

Secondary Outcomes (8)

• Change in School Functioning

  At enrollment, 1 month, 3 months, and 6 months

• Change in Family Functioning

  At enrollment, 1 month, 3 months, and 6 months

• Change in Parent Anxiety Symptoms

  At enrollment, 1 month, 3 months, and 6 months

• Change in Parent Depressive Symptoms

  At enrollment, 1 month, 3 months, and 6 months

• Change in ImPACT Assessment

  At enrollment and 6 months

Study Arms (2)

Experimental

EXPERIMENTAL

Stepped Care

Behavioral: Stepped Care

Control

NO INTERVENTION

Usual Care

Interventions

Stepped Care BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Childrens Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• McCarty CA, Zatzick D, Stein E, Wang J, Hilt R, Rivara FP; Seattle Sports Concussion Research Collaborative. Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20160459. doi: 10.1542/peds.2016-0459. Epub 2016 Sep 13.

  PMID: 27624513 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Frederick P Rivara, MD, MPH

  Seattle Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seattle Children's Guild Endowed Chair in Pediatrics

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

US (1)