A Study of Internet Delivered Parent Child Interaction Therapy
- Conditions
- Disruptive Behavior
- Interventions
- Behavioral: Remote PCIT augmented with wearable devices
- Registration Number
- NCT05725525
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to learn more about how feasible remote parent child interaction therapy (PCIT) is for children with disruptive behaviors and how to augment treatment with wearable devices.
- Detailed Description
Children with disruptive behaviors aged 3-7 will wear a Garmin watch throughout the course of the study (approximately 12 weeks). Artificial Intelligence (AI) will be applied to analyze the vitals provided by the watch to monitor for disruptive behavior. Parent and child will be enrolled in remote PCIT sessions throughout the course of the trial. This study will not require any in person visits, all materials will be mailed to the patients home or sent electronically. The study will analyze how the use of a wearable device throughout PCIT will help increase the benefit to both parent and child as measured by biometrics via Garmin and by questionnaires preformed throughout the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Wearable Device Intervention Remote PCIT augmented with wearable devices An open label, non randomized trial that requires all participants to wear a Garmin watch throughout the course of the trial (\~12 weeks).
- Primary Outcome Measures
Name Time Method How wearing a Garmin watch will help the remote PCIT clinical outcomes Through study completion, approximately 2 years Biometrics from the Garmin watch will be analyzed through Fitabase: step count, activity intensity, calories, heartrate, and respirations. This data will be compared throughout the study to see if factors trend down by the end of the trial. This would indicate that the child's behaviors were calmer at the end of the therapy when compared to the beginning.
Evaluating parental acceptance of remote PCIT augmented with a Garmin device Through study completion, approximately 2 years At the end of therapy, the parent will receive an emailed survey asking about their opinions of the study technology and how it added to their child's therapy experience.
Number of participants able to wear the Garmin watch throughout remote PCIT Through study completion, approximately 2 years The study will measure how often participants are wearing the device by monitoring two platforms that are paired with the watch: Fitabase and Ilumivu. These platforms inform the study team with wear time of the watch by the participant. A measurement of at least 70% of the time will be deemed feasible/acceptable for young patient's ability to wear the watch during therapy.
- Secondary Outcome Measures
Name Time Method Evaluating clinical improvement from remote PCIT in regards to sleep Through study completion, approximately 2 years The study will collect parental rating scale measures of their child's sleep (PSQ). These reports will be collected weekly and will be compared throughout the course of therapy to see if parental reports of sleep gets better (length of time child is in bed and sleeping increases by the end of therapy).
Evaluating clinical improvement from remote PCIT in regards to parental reports of behavior accuracy of indirect behavioral measures from wearable devices to parental ratings Through study completion, approximately 2 years The study will collect weekly parental ratings of their child's behavior (ECBI). These reports will be compared throughout the course of therapy to see if reports of the child's behavior is getting better throughout therapy.
Evaluating measured sleep data throughout remote PCIT Through study completion, approximately 2 years The Garmin device will measure sleep cycle data (deep sleep, light sleep, REM sleep and hours awake). This data will be analyzed throughout participation to see if overall sleep time and quality increases with the amount of time spent in therapy.
Trial Locations
- Locations (1)
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States