Cited by 4Digital Mental Health InterventionsChild and Adolescent Psychosocial and Emotional DevelopmentChild Development and Digital Technology

Feasibility of Digital Augmentation of Parent-Child Interaction Therapy: A Randomized Clinical Trial

Open access
Romanowicz, Magdalena, Saliba, Maria T., Wilton, Angelina R., Garzon Hincapie, Juan F., Croarkin, Kyle S., Saliba, Christina T., LeMahieu, Allison, Drapeau, Noelle +7 more·2025·JAMA Network Open

Abstract

Importance: The potential utility of real-time digital therapeutics that identify impending behavioral outbursts to proactively apply evidence-based interventions for managing children with disruptive behavior disorder has not been tested. Objectives: To evaluate feasibility and adherence of a digitally augmented, real-time, proactive behavioral intervention (smartwatch) for children with disruptive behaviors. Design, Setting, and Participants: This randomized clinical trial was conducted between March 1, 2022, and December 31, 2023, at Mayo Clinic in Rochester, Minnesota. The study enrolled children aged 3 to 7 years with externalizing behavior problems rated above the clinically significant range (I score ≥120; T score ≥60) on the Eyberg Child Behavior Inventory (ECBI). Interventions: Twelve weekly sessions of parent-child interaction therapy (PCIT) (treatment as usual [TAU] arm) vs artificial intelligence (AI)-enhanced PCIT augmented with real-time behavioral outburst alerts (PCIT-AI arm). Main Outcomes and Measures: The primary outcome was achieving the a priori feasibility benchmark set at greater than 70% for both completion of PCIT sessions and daily smartwatch wear. Parental reaction time to behavior prompts was measured in seconds. Secondary outcomes were percentage changes in ECBI and Pediatric Sleep Questionnaire scores. Behavioral outburst duration was examined based on parental logs of start and end times of observed tantrums using a smartphone application. Result: This study enrolled 50 children (median [IQR] age, 5.0 [4.0-6.0] years; 34 [68%] male and 16 [32%] female; 28 randomized to the PCIT-AI arm and 22 to the PCIT-TAU arm). Of these children, 37 (74%; 21 in the PCIT-AI arm and 16 in the PCIT-TAU arm) completed PCIT, with children wearing the watch a median (IQR) 75.7% (67.8%-82.9%) of the time, thus achieving the feasibility benchmark (primary outcome). Median (IQR) response time to behavior prompts in the PCIT-AI arm was 3.65 (2.07-7.08) seconds. Assessing between-group differences, there was no statistically significantly greater numerical improvement in ECBI-intensity percentage change (13.86%; 95% CI, -1.41% to 29.14%), ECBI-problem percentage change subscale scores (38.59%; 95% CI, -1.22% to 78.40%), or absolute change in Pediatric Sleep Questionnaire scores (-0.16; 95% CI, -1.85 to 1.53) with the PCIT-AI arm than with the PCIT-TAU arm. Children in the PCIT-AI arm had significantly shorter mean (SD) tantrum durations (10.4 [20.8] minutes vs 22.1 [30.0] minutes; P < .001) and lower odds of tantrums lasting for 15 minutes or more (odds ratio, 3.66; 95% CI, 2.72-4.95). Conclusions and Relevance: In this randomized clinical trial, both recruitment and technology feasibility benchmarks were achieved. The findings inform the design of fully powered efficacy study of wearable, digitally augmented PCIT for children with disruptive behaviors. Trial Registration: ClinicalTrials.gov Identifier: NCT05077722.

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  1. [5]Sisterhen LL, Wy PAW. Temper Tantrums. StatPearls; 2025. 31335006
  2. [24]Bergenstal RM. Understanding continuous glucose monitoring data. In: Role of Continuous Glucose Monitoring in Diabetes Treatment. ADA Clinical Compendia Series. American Diabetes Association; 2018. 34251769

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Authors
Romanowicz, M., Saliba, M. T., Wilton, A. R., Garzon Hincapie, J. F., Croarkin, K. S., Saliba, C. T., LeMahieu, A., Drapeau, N., Schlichting, B., Skime, M., Bobo, W. V., Vande Voort, J. L., Shekunov, J., Croarkin, P. E., & Athreya, A. P.
Affiliations
  • Mayo Clinic (US)
  • Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota
  • Florida State University (US)
Corresponding author
  • Romanowicz, Magdalena
  • Athreya, Arjun P.
Venue
JAMA Network Open
Published
2025-12-15
Volume
8
Issue
12
Pages
e2548869
ISSN
2574-3805 (ISSN-L)
OpenAlex
W4417334189
Cited by
4
References
28
Citations by year
2026: 4
FWCI
3.20
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JAMA Network Open (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion, cc-by)
Topics
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
  • Social Sciences › Education › Child Development and Digital Technology
Keywords
Parent-Child Interaction Therapy, disruptive behavior disorders, digital therapeutics, smartwatches, artificial intelligence, externalizing problems, preschool children, medication adherence, feasibility, sleep disorders, tantrums, Eyberg Child Behavior Inventory, Pediatric Sleep Questionnaire, mobile application
MeSH terms
Behavior Therapy, Child, Child Behavior Disorders, Child, Preschool, Feasibility Studies, Female, Humans, Male, Parent-Child Relations

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