Disruptive BehaviorNCT04628546
The Parenting Young Children Check-up Evaluation
A study testing The Parenting Young Children Check-up Initial Check-up and Text Messages and The Parenting Young Children Check-up Flier and Text Messages in people with Disruptive Behavior and Parenting, run by Wayne State University at 1 site in United States.
Trial summary
The PYCC is a system for parents of young children (2-5 years old) with Disruptive Behavior Problems (DBPs). The program is designed with the intentions of being used a pediatric primary care visit. Parents that report elevated child behavior problems go through a three part program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disruptive Behavior, Parenting
- What is being tested?
- The Parenting Young Children Check-up Initial Check-up and Text Messages and The Parenting Young Children Check-up Flier and Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- English speaking
- Parent to a child ages 2-5
- Report their child has elevated disruptive behavior problems on the Eyberg Child Behavior Inventory
- Have Smartphone and CIAS program works on their phone
Who cannot join
- Parent report that their child has an Autism Spectrum Disorder diagnosis
- Parent report that their child has an intellectual disability
- Parent report that their child is receiving treatment of Oppositional Defiant Disorder or ADHD
Trial locations and contacts
1 site in 1 country.
United States1 site
Merrill Palmer Skillman Institute
Detroit, Michigan, 48236
About this study
Official title: Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors: Pilot Randomized Clinical Trial
The PYCC is a system for parents of young children (2-5 years old) with Disruptive Behavior Problems (DBPs). The program is designed with the intentions of being used a pediatric primary care visit. Parents that report elevated child behavior problems go through a three part program. First, they go through a brief intervention on a tablet (i.e., the initial check-up) to receive feedback and learn about the PYCC; the aim is to build motivation to make parenting changes and engage in the parenting young children check-up. Next, parents receive text messages to connect them to further parent training content. Finally, parent training content is delivered via a web-based resource (i.e., the PYCC website), which includes videos to teach parenting skills. In this pilot RCT, the investigators will focus on examining the impact of the brief intervention (i.e., the initial check-up). Secondarily, the investigators will examine overall impact of the whole PYCC program and use of the parenting training website.
Parents will learn about the research opportunity through select community-based organizations in Detroit, Michigan, local posting, and a local participant registry. Through a phone call, parents will complete a demographics questionnaire and the DBP screener. The investigators aim to screen 200 parents in order to enroll 40 parents in the clinical trial.
Read more
If parents report elevated DBPs and do not meet any exclusion criteria, then they will be eligible to further participate. Parents that are eligible will complete a consent form (i.e., an online information sheet) and then be randomly assigned to intervention (n = 20) or control (n = 20). Both groups will complete a brief baseline. Both groups will also learn about the Parenting Young Children Check-up (PYCC). However, the way in which they learn about the program will differ. The control group will see a brief description about the program (i.e., an online flier) and will receive a brochure for the program through the mail. The intervention group will go through the full PYCC initial check-up and also receive a brochure through the mail. Both groups will receive text messages prompting them to engage in the PYCC.
After initial participation, parents will be free to use, or not use, the Parenting Young Children Check-up web-based resource as much as they want. Parents will enter their phone number and first name when accessing the web-based content in order for use to track their engagement. All use of the web-based resource will start with "Session 1. In this, they will choose what parenting skills they want to learn. If parents go through session 1, they will be further connected to PYCC content through tailored text messages. Texts contain links to all PYCC web-based content. Parents will be able to learn content related to "Special Time," "Labeled Praise," "Family Rules," "Effective Commands," "Offering Choices," "Routines," "Removing Attention," "Logical Consequences," and "Time out." All content of the PYCC is based on evidence-based parent training program content.
The purpose of this project is evaluate the Parenting Young Children Check-up. In particular, the investigators are interested in if the initial check-up leads parents to engage in the PYCC (i.e., completing session 1 and using the parent training content on the PYCC website).
Hypotheses include:
Primary Hypothesis: The intervention group (i.e. those randomized to complete the full initial check-up) will visit the parent training website more than the control group. The investigators hypothesize that, compared to the control group, more parents in the control group with complete "session 1," and use the PYCC web-based content to learn parenting skills (i.e., more parents will use any of this content and parents will use it more frequently).
Secondary Hypothesis (a): Participants assigned to the intervention group, as compared to those in the control group, will have higher scores for all domains consistent with the Theory of Planned Behavior at follow-up.
Secondary Hypothesis (b). Participants in the intervention group will report high levels of satisfaction (i.e., >=4 on a 5-point scale).
The investigators will also explore the impact of the PYCC on reported parenting and child behavior problems. Furthermore, the investigators will explore the impact of the initial check-up on intentions to use the parent training website.
- Conditions
- Disruptive Behavior, Parenting
- Being tested
- The Parenting Young Children Check-up Initial Check-up and Text Messages, The Parenting Young Children Check-up Flier and Text Messages
- Keywords
- Parenting Interventions, Parent Training, Preschool-aged Children, Technology-based intervention, Brief Intervention, Disruptive Behavior Problems
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Parenting Young Children Check-up Initial Check-up and Text MessagesBehavioural
Parents assigned to the intervention condition will go through the Initial Check-up, which is a brief intervention that uses motivational content to promote use of the Parenting Young Children Check-up parenting education website. They will also receive text messages and a brochure to connect them to the parenting education website.
The Parenting Young Children Check-up Flier and Text MessagesBehavioural
Parents assigned to the control condition will not go through the Parenting Young Children Check-up Initial Check-up. They will only go through assessment and then see a brief flier about the Parenting Young Children. Like the intervention condition, they will also receive text messages and a brochure to connect them to the Parenting Young Children Check-up parenting education website.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: The Parenting Young Children Check-up Initial Check-up and Text Messages; Behavioral: The Parenting Young Children Check-up Flier and Text Messages |
| Assessment Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial use of the parenting training website session 1
After learning about the program, the first point of program use is session 1 (i.e., selecting parenting skill to learn first); the investigators will track if parents completed session 1 (1) or did not (0)
Measured: 1 month
Use of parent training content on the PYCC website (binary; yes or no)
The investigators will measure if parents use the parent training content on the Parenting Young Children Check-up Website (binary; yes or no)
Measured: 1 month
Number of uses of parent training content on the PYCC website
The investigators will track how many of the parent training content modules parents use; there are 9 different areas of training content with two modules each, thus there is a possible range of 0-18
Measured: 1 month
Use of parent training content on the PYCC website (binary; yes or no)
The investigators will measure if parents use the parent training content on the Parenting Young
Measured: 3 months
Number of uses of parent training content on the PYCC website
The investigators will track how many of the parent training content modules parents use; there are 9 different areas of training content with two modules each, thus there is a possible range of 0-18
Measured: 3 months
Secondary outcomes (4)
Change in Attitudes, norms, and perceived behavioral control; consistent with the Theory of Planned Behavior
Nine items total with 3 items each taping into each of the three elements of TPB (perceived norms, attitude, behavioral control); Rated on a 5 point scale (0 = Strongly Disagree, 1 = Disagree, 2 = neither disagree nor agree, 3 = Agree, 4 =Strongly Agree)
Measured: Baseline; 1 month
Change in Attitudes, norms, and perceived behavioral control; consistent with the Theory of Planned Behavior
Nine items total with 3 items each taping into each of the three elements of TPB (perceived norms, attitude, behavioral control); Rated on a 5 point scale (0 = Strongly Disagree, 1 = Disagree, 2 = neither disagree nor agree, 3 = Agree, 4 =Strongly Agree)
Measured: Baseline; 3 months
Technology Acceptance with initial check-up
6 Items specific to the initial check-up derived from the technology acceptance model tapping including ease of use, usefulness, and satisfaction, 5-point scale (0 = Strongly Disagree, 1 = Disagree, 2 = neither disagree nor agree, 3 = Agree, 4 =Strongly Agree)
Measured: Baseline;
Technology Acceptance Parenting Young Children Check-up
18 Items focused on all the elements the PYCC program that are derived from the 1technology acceptance model and tap into ease of use, usefulness, and satisfaction; 5-point scale (0 = Strongly Disagree, 1 = Disagree, 2 = neither disagree nor agree, 3 = Agree, 4 =Strongly Agree)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start29 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty parents that will be randomly assigned to the intervention group (random assignment determined through a random number generator). Twenty parents will be assigned to a control condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy (Kathleen) McGoron, Ph.D., Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628546
- Sponsor's protocol ID
- K01MH110600B
- Other IDs
- K01MH110600
- Status last verified
- Nov 2021
- First submitted
- 28 Sep 2020
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Motivational mHealth Parent Training for Child Disruptive Behaviors: Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04628546
- Acronym / sponsor ID
- K01MH110600B
- Conditions
- Disruptive Behavior, Parenting
- Keywords
- Parenting Interventions, Parent Training, Preschool-aged Children, Technology-based intervention, Brief Intervention, Disruptive Behavior Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PYCC is a system for parents of young children (2-5 years old) with Disruptive Behavior Problems (DBPs). The program is designed with the intentions of being used a pediatric primary care visit. Parents that report elevated child behavior problems go through a three part program. First, they go through a brief intervention on a tablet (i.e., the initial check-up) to receive feedback and learn about the PYCC; the aim is to build motivation to make parenting changes and engage in the parenting young children check-up. Next, parents receive text messages to connect them to further parent training content. Finally, parent training content is delivered via a web-based resource (i.e., the PYCC website), which includes videos to teach parenting skills. In this pilot RCT, the investigators will focus on examining the impact of the brief intervention (i.e., the initial check-up). Secondarily, the investigators will examine overall impact of the whole PYCC program and use of the parenting training website.
Parents will learn about the research opportunity through select community-based organizations in Detroit, Michigan, local posting, and a local participant registry. Through a phone call, parents will complete a demographics questionnaire and the DBP screener. The investigators aim to screen 200 parents in order to enroll 40 parents in the clinical trial.
If parents report elevated DBPs and do not meet any exclusion criteria, then they will be eligible to further participate. Parents that are eligible will complete a consent form (i.e., an online information sheet) and then be randomly assigned to intervention (n = 20) or control (n = 20). Both groups will complete a brief baseline. Both groups will also learn about the Parenting Young Children Check-up (PYCC). However, the way in which they learn about the program will differ. The control group will see a brief description about the program (i.e., an online flier) and will receive a brochure for the program through the mail. The intervention group will go through the full PYCC initial check-up and also receive a brochure through the mail. Both groups will receive text messages prompting them to engage in the PYCC.
After initial participation, parents will be free to use, or not use, the Parenting Young Children Check-up web-based resource as much as they want. Parents will enter their phone number and first name when accessing the web-based content in order for use to track their engagement. All use of the web-based resource will start with "Session 1. In this, they will choose what parenting skills they want to learn. If parents go through session 1, they will be further connected to PYCC content through tailored text messages. Texts contain links to all PYCC web-based content. Parents will be able to learn content related to "Special Time," "Labeled Praise," "Family Rules," "Effective Commands," "Offering Choices," "Routines," "Removing Attention," "Logical Consequences," and "Time out." All content of the PYCC is based on evidence-based parent training program content.
The purpose of this project is evaluate the Parenting Young Children Check-up. In particular, the investigators are interested in if the initial check-up leads parents to engage in the PYCC (i.e., completing session 1 and using the parent training content on the PYCC website).
Hypotheses include:
Primary Hypothesis: The intervention group (i.e. those randomized to complete the full initial check-up) will visit the parent training website more than the control group. The investigators hypothesize that, compared to the control group, more parents in the control group with complete "session 1," and use the PYCC web-based content to learn parenting skills (i.e., more parents will use any of this content and parents will use it more frequently).
Secondary Hypothesis (a): Participants assigned to the intervention group, as compared to those in the control group, will have higher scores for all domains consistent with the Theory of Planned Behavior at follow-up.
Secondary Hypothesis (b). Participants in the intervention group will report high levels of satisfaction (i.e., >=4 on a 5-point scale).
The investigators will also explore the impact of the PYCC on reported parenting and child behavior problems. Furthermore, the investigators will explore the impact of the initial check-up on intentions to use the parent training website.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Twenty parents that will be randomly assigned to the intervention group (random assignment determined through a random number generator). Twenty parents will be assigned to a control condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The Parenting Young Children Check-up Initial Check-up and Text Messages, Behavioral: The Parenting Young Children Check-up Flier and Text Messages |
| Assessment Only | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or above
- English speaking
- Parent to a child ages 2-5
- Report their child has elevated disruptive behavior problems on the Eyberg Child Behavior Inventory
- Have Smartphone and CIAS program works on their phone
Key exclusion criteria (3 listed)
- Parent report that their child has an Autism Spectrum Disorder diagnosis
- Parent report that their child has an intellectual disability
- Parent report that their child is receiving treatment of Oppositional Defiant Disorder or ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Parenting Young Children Check-up Initial Check-up and Text MessagesParents assigned to the intervention condition will go through the Initial Check-up, which is a brief intervention that uses motivational content to promote use of the Parenting Young Children Check-up parenting education website. They will also receive text messages and a brochure to connect them to the parenting education website. | Behavioural | Intervention |
| The Parenting Young Children Check-up Flier and Text MessagesParents assigned to the control condition will not go through the Parenting Young Children Check-up Initial Check-up. They will only go through assessment and then see a brief flier about the Parenting Young Children. Like the intervention condition, they will also receive text messages and a brochure to connect them to the Parenting Young Children Check-up parenting education website. | Behavioural | Intervention |
Primary outcome
Initial use of the parenting training website session 1
Time frame: 1 month
After learning about the program, the first point of program use is session 1 (i.e., selecting parenting skill to learn first); the investigators will track if parents completed session 1 (1) or did not (0)
Use of parent training content on the PYCC website (binary; yes or no)
Time frame: 1 month
The investigators will measure if parents use the parent training content on the Parenting Young Children Check-up Website (binary; yes or no)
Number of uses of parent training content on the PYCC website
Time frame: 1 month
The investigators will track how many of the parent training content modules parents use; there are 9 different areas of training content with two modules each, thus there is a possible range of 0-18
Use of parent training content on the PYCC website (binary; yes or no)
Time frame: 3 months
The investigators will measure if parents use the parent training content on the Parenting Young
Number of uses of parent training content on the PYCC website
Time frame: 3 months
The investigators will track how many of the parent training content modules parents use; there are 9 different areas of training content with two modules each, thus there is a possible range of 0-18
4 secondary outcomes
Change in Attitudes, norms, and perceived behavioral control; consistent with the Theory of Planned Behavior
Time frame: Baseline; 1 month
Change in Attitudes, norms, and perceived behavioral control; consistent with the Theory of Planned Behavior
Time frame: Baseline; 3 months
Technology Acceptance with initial check-up
Time frame: Baseline;
Technology Acceptance Parenting Young Children Check-up
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
Related trials for Disruptive Behavior
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Parenting Young Children Check-up Initial Check-up and Text Messages and The Parenting Young Children Check-up Flier and Text Messages in people with Disruptive Behavior and Parenting, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial use of the parenting training website session 1 (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.