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Recruiting NCT07219095

Dance Mental Health App

No phase Interventional Ankle Injury Foot Injury Lower Extremity Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mental Health App.
Who it may be relevant to
Registry conditions: Ankle Injury, Foot Injury, Lower Extremity Injury. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Use of a Mental Health App in the Recovery of Adolescent Dancers From a Lower Extremity Injury: A Randomized Controlled Trial

Overview

This project aims to enhance self-compassion in adolescent dancers recovering from a foot and ankle injury by incorporating the use of a mental health intervention app using gamified design during their recovery.

Interventions

  • Device Mental Health App
    Participants will use the SuperBetter mobile app to participate in gamified mental health activities 5 days per week, 10 minutes per day, for 12 weeks alongside their physical therapy.

Primary outcome measures

  • Number (or percentage) of participants who have returned to full, unrestricted dance after injury [Time frame: 3, 6 and 12 months.]
Secondary outcome measures (3)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Measures of Pediatric Anxiety, Depressive Symptoms, Pain Interference, and Mobility questionnaire [Time frame: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months]
  • Self Compassion Scale (SCS) - Short Form questionnaire [Time frame: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months]
  • Foot and Ankle Ability Measure (FAAM) Activities of Daily Living subscale and Sports Subscale questionnaire [Time frame: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months]

Eligibility criteria

Inclusion criteria

  • Provision of informed consent (adult participant), or consent of parent/legal guardian in conjunction with adolescent assent (minor participant)
  • 13 to 18 years of age
  • Endorses dance as their primary sport, or participates 3 days per week or greater in dance prior to injury
  • Stated willingness to comply with all study procedures including the intervention regimen and availability for the duration of the study
  • Access to a device with which the SuperBetter app can be downloaded and used

Exclusion criteria

  • Dance is not a primary sport or less than 3 days per week spent dancing prior to injury (skater, gymnast, other sport)
  • Requiring surgery or prior surgery for the injury being treated
  • Injury outside of the leg below the knee
  • Known eating disorder or bone density issue (documented abnormal Z score and/or eating disorder diagnosis upon review of the medical chart)
  • Verbalized plans to not return to dance after recovery from the injury

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rady Children's Hospital — San Diego

Publications

  • Christino MA, Fantry AJ, Vopat BG. Psychological Aspects of Recovery Following Anterior Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2015 Aug;23(8):501-9. doi: 10.5435/JAAOS-D-14-00173. PMID 26209145
  • Gennarelli SM, Brown SM, Mulcahey MK. Psychosocial interventions help facilitate recovery following musculoskeletal sports injuries: a systematic review. Phys Sportsmed. 2020 Nov;48(4):370-377. doi: 10.1080/00913847.2020.1744486. Epub 2020 Mar 25. PMID 32186423
  • Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18. PMID 32439401
  • Neff KD, Toth-Kiraly I, Yarnell LM, Arimitsu K, Castilho P, Ghorbani N, Guo HX, Hirsch JK, Hupfeld J, Hutz CS, Kotsou I, Lee WK, Montero-Marin J, Sirois FM, de Souza LK, Svendsen JL, Wilkinson RB, Mantzios M. Examining the factor structure of the Self-Compassion Scale in 20 diverse samples: Support for use of a total score and six subscale scores. Psychol Assess. 2019 Jan;31(1):27-45. doi: 10.1037 PMID 30124303
  • Worthen-Chaudhari L, McGonigal J, Logan K, Bockbrader MA, Yeates KO, Mysiw WJ. Reducing concussion symptoms among teenage youth: Evaluation of a mobile health app. Brain Inj. 2017;31(10):1279-1286. doi: 10.1080/02699052.2017.1332388. Epub 2017 Jun 30. PMID 28665690
  • Psihogios AM, Stiles-Shields C, Neary M. The Needle in the Haystack: Identifying Credible Mobile Health Apps for Pediatric Populations during a Pandemic and beyond. J Pediatr Psychol. 2020 Nov 1;45(10):1106-1113. doi: 10.1093/jpepsy/jsaa094. PMID 33068424
  • Semenchuk BN, Strachan SM, Fortier M. Self-Compassion and the Self-Regulation of Exercise: Reactions to Recalled Exercise Setbacks. J Sport Exerc Psychol. 2018 Feb 1;40(1):31-39. doi: 10.1123/jsep.2017-0242. Epub 2018 Mar 26. PMID 29580155
  • Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3. PMID 32125190

Identifiers

NCT: NCT07219095 · 812643

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗