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NCT05622461 · ClinicalTrials.gov registry record · NA

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

A NA study of Traumatic Brain Injury and Head Injury, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
1
Study location

NCT05622461: Recruiting NA study of Traumatic Brain Injury and Head Injury, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT05622461 is a NA study of Traumatic Brain Injury and Head Injury that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 200 participants, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05622461, a NA study of Traumatic Brain Injury and Head Injury, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

Primary Outcome

Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety

Interventions

  • BEHAVIORAL Road-to-recovery

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2023-02-13
Est. Completion 2026-08-31
Phase NA

What NCT05622461 shows while recruiting

NCT05622461 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (28% lower).

The record links to 6 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Road-to-recovery is the first listed.

NCT05622461 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT05622461 about?

NCT05622461 is a clinical study titled "Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery". This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-...

What is the current status of trial NCT05622461?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-02-13. Estimated completion is 2026-08-31.

What conditions does trial NCT05622461 study?

This clinical trial studies the following conditions: Traumatic Brain Injury, Head Injury, Head Injuries, Closed, Brain Hemorrhage, Traumatic, Brain Edema.

What interventions are being tested in trial NCT05622461?

The interventions under investigation include: Road-to-recovery (BEHAVIORAL).

Who is sponsoring clinical trial NCT05622461?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05622461 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Traumatic Brain Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05622461's enrollment target sits among peer trials

200 33rd of 171 higher than 137 of 171 other Traumatic Brain Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05622461, the US trial registry maintained by the National Library of Medicine. NCT05622461 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.