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Behavioral Intervention

Mobile App for Family Mental Health

N/A
Recruiting
Led By Matthew Ahle, B.S.
Research Sponsored by Colliga Apps Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a child 6-9 years old at the time of enrollment
Must not have
Active suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial aims to test a mobile app that provides real-time feedback to families to improve their mental health. Participants will use the app and researchers will compare if it helps improve mental health compared to a control

Who is the study for?
This trial is for families looking to improve their mental health and family functioning. Participants will need a smartphone to download an app for the intervention sessions.
What is being tested?
The study tests an app-based just-in-time adaptive intervention (JITAI) designed to provide immediate feedback and coaching to enhance child and family mental health, comparing its effectiveness with a control group.
What are the potential side effects?
Since this is an app-based intervention, there are no direct medical side effects. However, participants may experience increased awareness of mental health issues or stress due to engagement with the content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a child aged 6-9 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently experiencing thoughts of harming myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Child attachment measured via the Attachment Style Classification Questionnaire for Latency Age Children
Child mental health symptoms measured by the Child Behavior Checklist
Parent-child conflict measured via the Parent-Child Conflict Tactics Scale
Secondary study objectives
Caregiver attachment measured via the Experiences in Close Relationships Scale
Caregiver mental health measured via the Symptoms Checklist 27-Plus
Inter-parental conflict measured via the Conflict Tactics Scale
Other study objectives
Caregiver physical health measured via the Patient Health Questionnaire
Child physical health measured via the Child Health Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention aims to improve child and family mental health and functioning through psychoeducation and family-based activities delivered via a smartphone app. This intervention also includes a just-in-time adaptive intervention (JITAI) for coaching family interactions in real-time. Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.
Group II: Control groupActive Control1 Intervention
Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. Participants will complete placebo psychoeducational modules matched in length and reading level to the intervention content. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.

Find a Location

Who is running the clinical trial?

Colliga Apps Corp.Lead Sponsor
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,179 Total Patients Enrolled
18 Trials studying Mental Health
4,887 Patients Enrolled for Mental Health
Matthew Ahle, B.S.Principal InvestigatorColliga Apps
~238 spots leftby Jun 2025
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