Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. The current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones. The main questions to answer are: Is parenting feedback provided by a smartphone application acceptable to caregivers? When parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?
Interventions
BEHAVIORALMobile behavioral parent training (mBPT)
The mobile phone application includes behavioral parent training content (for example, praise, effective commands, reward systems) delivered in videos, examples, and quizzes that parents/caregivers access.
BEHAVIORALIn the moment feedback
In-the-moment feedback will include parenting feedback.
BEHAVIORALIn the moment suggestions
In-the-moment feedback will include suggestions for parenting strategies.
Sponsors
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
All participants receive access to a beta version of the mobile behavioral parent training application. Each participant is randomized multiple times per day (about 4-6 times per day) to received either no push notification (50% chance) or a push notification providing parenting feedback or a suggestion to use a parenting strategy (50% chance).
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Child Inclusion Criteria: * Currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD * Ages 7 -12 * Has parent-reported impairment in homework performance defined as a score of 3 or greater on an Impairment Rating Scale measure (Fabiano et al., 2006) of homework performance * Has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone.
Exclusion criteria
* N/A Caregiver Participant Inclusion Criterion: \- 18 years old or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Passive Audio Data-Positive Sentiment Analysis | Through study completion, average of 5 weeks | Parent and child interaction behavior- proportion of recorded interaction that is labeled positive via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization. |
| Passive Audio Data-Negative Sentiment Analysis | Throughout study completion, average of 5 weeks | Parent and child interaction behavior- proportion of recorded interaction that is labeled negative via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Engagement | Through study completion, average of 5 weeks | Number of mobile BPT sessions completed divided by the total number of sessions available. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in 2024 via social media advertising, e-mail contact lists, community partnerships, area pediatric offices, local schools and other methods. 185 families were screened, 133 were interested and potentially eligible, 50 families provided consent for study and eligibility evaluation, and 16 were excluded due to not completing intake forms, being unreachable, declining participation, or being ineligible resulting in 34 enrolled.
Pre-assignment details
Prior to assignment, participants downloaded the phone application. Participants that were not successful in downloading and launching the application (n = 7) due to a variety of reasons spanning technical, user specific, or personal, were never micro-randomized or assigned to a condition. Nor could they provide feedback regarding intervention content. Resulting in data for 27 participating dyads.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Adult Caregiver Participants | 42.30 Years STANDARD_DEVIATION 5.32 |
| Age, Continuous Child Participants | 9 Years STANDARD_DEVIATION 1.59 |
| Ethnicity (NIH/OMB) Adult Caregiver Participants Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Adult Caregiver Participants Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Adult Caregiver Participants Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Child Participants Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Child Participants Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Child Participants Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Adult Caregiver Participants American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Adult Caregiver Participants Asian | 0 Participants |
| Race (NIH/OMB) Adult Caregiver Participants Black or African American | 2 Participants |
| Race (NIH/OMB) Adult Caregiver Participants More than one race | 0 Participants |
| Race (NIH/OMB) Adult Caregiver Participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Adult Caregiver Participants Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) Adult Caregiver Participants White | 23 Participants |
| Race (NIH/OMB) Child Participants American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Child Participants Asian | 0 Participants |
| Race (NIH/OMB) Child Participants Black or African American | 3 Participants |
| Race (NIH/OMB) Child Participants More than one race | 0 Participants |
| Race (NIH/OMB) Child Participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Child Participants Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Child Participants White | 23 Participants |
| Sex: Female, Male Adult Caregiver Participants Female | 25 Participants |
| Sex: Female, Male Adult Caregiver Participants Male | 2 Participants |
| Sex: Female, Male Child Participants Female | 10 Participants |
| Sex: Female, Male Child Participants Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
None listed