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Behavioural Intervention

Pathway 5 for Concussion (CHIP Trial)

N/A

Recruiting

Led By Carolyn A McCarty, PhD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

11-18 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)

Awards & highlights

CHIP Trial Summary

This trial aims to improve the treatment for youth who have persistent post-concussive symptoms (PPCS) after sustaining a concussion. Currently, there are limited evidence-based treatments available for these youth.

Who is the study for?

This trial is for young people aged 11-18 who've been diagnosed with a concussion by a healthcare provider within the past 1-6 months and are experiencing at least three new or worsening symptoms after their injury.Check my eligibility

What is being tested?

The study tests a treatment combining cognitive therapy, parent skills training, and care management to help youths recover from post-concussive symptoms. Participants will be randomly assigned to one of eight groups to determine which parts of the treatment are most effective.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like therapy and skills training, traditional side effects associated with medications are not expected. However, participants may experience emotional discomfort during sessions.

CHIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 11 and 18 years old.

CHIP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Health Behavior Inventory (HBI)

Pediatric Quality of Life Inventory (PedsQL)

Secondary outcome measures

Adolescent Sleep Wake Scale-10 item (ASWS-10)

Generalized Anxiety Disorder-7 item (GAD-7)

Headache daily diary

+3 more

Other outcome measures

Adult responses to child's symptoms (ARCS)

Generalized self-efficacy (GSE)

Parent-Patient Activation Measure (P-PAM)

CHIP Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Pathway 7Experimental Treatment1 Intervention

CM only

Group II: Pathway 6Experimental Treatment1 Intervention

PST only

Group III: Pathway 5Experimental Treatment1 Intervention

PST & CM

Group IV: Pathway 4Experimental Treatment2 Interventions

cf-CBT only

Group V: Pathway 3Experimental Treatment2 Interventions

cf-CBT & CM

Group VI: Pathway 2Experimental Treatment2 Interventions

cf-CBT & PST

Group VII: Pathway 1Experimental Treatment3 Interventions

All interventions: cf-CBT, PST & CM

Group VIII: Pathway 8Active Control1 Intervention

No interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parent skills training

2019

N/A

~200

Care management

2012

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

304 Previous Clinical Trials

5,216,726 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,423 Total Patients Enrolled

University of Texas Southwestern Medical CenterOTHER

1,048 Previous Clinical Trials

1,053,361 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently accepting new participants?

"Indeed, as per clinicaltrials.gov, this trial is currently in the process of seeking eligible participants. The initial posting date was on October 26th, 2023 and it underwent its latest revision on December 22nd, 2023."

Answered by AI

What are the main goals being pursued in this clinical research?

"- Adolescent Sleep Wake Scale-10 item (ASWS-10): A measurement tool assessing sleep quality in domains such as falling asleep, reinitiating sleep, and returning to wakefulness. Some items are"

Answered by AI

What is the upper limit for the number of participants who can be enrolled in this research endeavor?

"Indeed, the data available on clinicaltrials.gov confirms that this study is actively seeking eligible candidates. The trial was originally posted on October 26th, 2023 and underwent its latest revision on December 22nd, 2023. A total of 374 participants are being recruited from a single site."

Answered by AI

Which specific group of individuals is the most suitable to participate in this study?

"This clinical study aims to enroll 374 individuals aged between 11 and 18 who have been diagnosed with a concussion by a healthcare professional within the past one to six months. Notably, applicants must exhibit at least three new or worsening post-concussive symptoms as measured using the HBI scale."

Answered by AI