ParentingNCT04059185
Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment
A study testing Triple P-Level 2 and Play Nicely in people with Parenting and Child Behavior, run by Tulane University at 1 site in United States.
Trial summary
Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Parenting, Child Behavior, Child Rearing
- What is being tested?
- Triple P-Level 2 and Play Nicely
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,133 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2014to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult participants must be:
- Women
- English-speaking
- adults, age 18 or older
- a parent of at least one child between 2 and 7 years of age
- a primary caregiver of that child
Show all 11Show fewer
- able to return to WIC (or recruitment site) for follow-up 3 months later
- available for up to 2 hours on date of recruitment to complete the baseline visit
- Child participants:
- must be the "index child" of the adult participant as indicated in the baseline interview
- all genders eligible
Who cannot join
- anyone who does not meet the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University School of Public Health and Tropical Medicine
New Orleans, Louisiana, 70112
About this study
Official title: Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment in a Selected Population
Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others
Read the detailed description
- Study design Our long-term goal is to enlarge the evidence base for low resource-intensive and widely adaptable interventions that effectively target parenting outcomes to reduce risk of child physical abuse in settings with broad reach. The objective of this study is to test the effectiveness of two such interventions in promoting effective parenting and reducing child physical abuse risk as compared with "usual care" parenting education. The central hypothesis is that each of two brief interventions, Triple P-L2 and Play Nicely, will be more effective in improving parenting effectiveness and reducing child behavioral and emotional problems than the "usual care" condition. Full scale Triple-P is an evidence-based, five-level system of interventions shown to reduce risk for child maltreatment when all 5 levels are implemented. However, implementation of a single level would be much less costly, more easily disseminated, and might in itself reduce risk in a broader population. Play Nicely is a brief computer-based intervention that has shown preliminary evidence for shifting attitudes about use of physical discipline when implemented in a pediatric primary care setting. However, it has yet to be tested within a large randomized-controlled trial (RCT). The rationale for this study is to be able to inform policy for parent service or clinic centers serving high-volumes of parents that are interested in adopting relatively low-resource intensive interventions in order to reduce risk of child physical abuse and improve child health and development trajectories. This is a community-based RCT. Parents (n=1200) with children 2 to 7 years of age will be recruited from local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics and by open recruitment. Once consented, they will be enrolled, a baseline interview will be conducted, and they will be randomly assigned to one of 3 conditions: (1) Triple P-Level 2 only (L2) intervention, (2) Play Nicely intervention, or (3) a "usual care" control group. Three months later, a follow-up interview will be conducted in order to test for intervention effects. In addition, a long term follow-up will be conducted to test sustained effects of the intervention. Participants' children (n=1200) will be enrolled for the long term follow-up. Children will be invited to participate in order for the adult participant to be observed interacting with the child in several very benign behavioral activities. Adult participants that do not want to enroll their child may participate in the long term follow-up survey which they will have previously consented to. Our study name for presentation in the local community is "Tulane Innovations in Positive Parenting Study" (TIPPS).
- Subject Population We will recruit a total number of 2400 participants for this study. We will recruit 1200 adult participants from City of New Orleans and Jefferson Parish WIC Clinics. During the long-term follow-up visit, one child for each adult with be enrolled (n=1200).
- Procedure
Recruitment: Recruitment has taken place in WIC clinic waiting rooms. If a parent is eligible and interested, the TIPPS Staff Member will then confirm that she has completed all necessary WIC documentation and that she is scheduled for a follow-up appointment with WIC before moving forward with consent and enrollment.
Baseline Interview: After the participant is taken through the informed consent process, a TIPPS Team Member will then conduct the Baseline interview. Once the Baseline Interview is complete (approximately 45 minutes), the participant will be informed of their random assignment to one of three conditions: (1) Triple P-Level 2, (2) Play Nicely, or (3) Control. The next procedure will then depend upon which of the three groups the person is assigned to. (See "Arms and Interventions" section for more details.) Debrief: Once both the Baseline Interview and the Intervention phase are complete, a TIPPS Team Member will schedule the 3-month Follow-Up Appointment, provide the control condition, provide an area-specific resource guide, and give the participant our incentive. The whole procedure (enrollment, baseline interview, intervention, and debrief) is expected to take no more than 2 hours.
3-Month Follow-Up Visit: If the participant has a WIC appointment, when they return to WIC for their 3-month visit and once they've completed their WIC documentation, a TIPPS Team Member will conduct the 3-month interview with them. This interview should take no more than 45 minutes. As with the baseline visit, childcare will be offered when available and the Suicide Risk Protocol will be followed if needed. In the event that the participant cannot return to the study site for their 3-month visit, the TIPPS team member will schedule the 3-Month interview as a phone interview. If the participant is unwilling or unable to complete the follow-up interview over the phone, a follow-up interview will be scheduled at a more convenient location for the participant, such as a local business or the participant's home.
The long term follow-up visit protocol described below is possible due to funding from NICHD which will fund this study from 7/2018 - 6/2023.
Long Term Follow-Up Visit : Participants will be asked to arrive at the research site with their child indicated as the index child in the baseline survey visit. A trained research team member will conduct the informed consent procedures followed at the baseline visit. If the adult participate does not want her child to participate, she may complete the long-term follow-up survey which she has consented to previously. If she agrees to participate and gives permission for her child to participate, she must review and sign a new consent form before participating in any Long Term Follow-Up activities. The informed consent form will be a record of the mother's agreement for both her and her child to participate. Upon completion of the informed consent process, a research assistant will conduct the Long Term Follow-Up interview with the adult participant. A separate research assistant will engage the child participant in several tasks. The first task will be the NIH Toolbox, which measures Cognitive flexibility and executive function, administered by tablet. Next, the child will be given the Marshmallow Test, which is an inhibitory control task where the child is told to wait for to eat a marshmallow until the research assistant returns to the room, and if they are able to wait, they will get two marshmallows. The time before the child eats the marshmallow is a validated measure of inhibitory control; inhibitory control has been found to be a significant predictor of child health and development outcomes across the life course.
Following the surveys, ECG data will be collected on the child and mother concurrently, acquired using Mindware Technologies mobile recorders, and transmitted via wireless signals to a computer monitored by a research assistant. After participant and child leads have been connected to ECG machines, the participant and child will do 3 very benign behavioral activities together: 1) watch a short video, 2) tell a story together, and 3) engage in a cooperative task (drawing with an Etch A Sketch). Interactions will be video recorded with parental consent and child assent and coding of parent and child behaviors will be done using the coding interactive behavior (CIB) coding system. Respiratory Sinus Arrhythmia (RSA) values will be processed in 30-second epochs across tasks for mothers and for children, and multilevel growth models will be built examining each 30-second epoch over the course of the task, relative to the individuals' baseline RSA. Dr. Drury will have full oversight of the dyadic coding of video recorded interactions between mother and child. Lastly, a TIPPS Team Member will provide the participant with locally-based health care resources guide.
- Benefits
There will be no direct benefits to subjects for participating in this research, but the knowledge gained from the study may benefit society in general. Anticipated benefits might include a participant's greater understanding of positive parenting techniques.
- Costs
There will be no costs to the subject for participating in this research study.
- Alternatives
Subjects always have the option to not participate in the research.
- Conditions
- Parenting, Child Behavior, Child Rearing
- Being tested
- Triple P-Level 2, Play Nicely, Usual care
- Keywords
- Child abuse, Child maltreatment
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple P-Level 2Other
Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.
Play NicelyOther
Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes.
Usual careOther
Our "usual care" control group participants receive a resource and referral list for local social services
| Study group | Role | What they receive |
|---|---|---|
| Program 1 | Experimental | Triple P-Level 2 (TPL2), parenting education and consultation Receives: Other: Triple P-Level 2 |
| Program 2 | Experimental | Play Nicely (PN), multimedia, computer-based parenting education Receives: Other: Play Nicely |
| Control | Placebo comparator | Our "usual care" control group participants receive a resource and referral list for local social services Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up
The measure was collected at baseline, 3 month post-intervention, and 4 year post-intervention. This question asks participants "How often on average in the past month have you spanked your child?" with seven categories: 0) never, 1) once or twice in the past month, 2) about once a week, 3) about twice a week, 4) about once every other day, 5) about once a day, and 6) more than once a day. Using the 0-6 score response range, the outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates decrease in frequency of spanking at the post-intervention timepoint.
Measured: Baseline, 3 months post-intervention, 4 years post-intervention
Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up
The Attitudes Towards Spanking (ATS) scale was collected at baseline, 3 months post-intervention, and 4 years post-intervention. The scale score response range was 0-28, with a higher number being stronger support for spanking. This change outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates a decrease in approval of spanking at the post-intervention time point.
Measured: Baseline, 3 months post-intervention, 4 years post-intervention
Secondary outcomes (25)
Parent - Child Discipline Practices
The Parental Discipline scale of the Parenting and Family Adjustment Scale (PAFAS) was collected at baseline, 3 month follow up, and long-term follow-up. This scale ranges from 0-54, with a higher number indicating more positive parenting.
Measured: Baseline, 3 months post-intervention, 4 years post-intervention
Child - Behavioral and Emotional Adjustment
The Child Adjustment and Parent Efficacy Scale (CAPES) scale was collected at baseline, 3 month follow-up, and long-term follow-up. This scale ranges from 0-81, with a higher number indicating increased levels of emotional or behavioral problems.
Measured: Baseline, 3 months post-intervention, 4 years post-intervention
Child - Externalizing, Internalizing, and Total Symptoms
The 113 item Child Behavior Checklist (CBCL) scale was collected at 4 year long-term follow-up. The outcome is a T-score calculated for total symptoms, with a higher score indicating more internalizing and externalizing behaviors. For the T-score of the CBCL, the population mean is 50 and the standard deviation is 10. T-Scores less than 60 are considered to be in the normal range, the borderline range consists of T-scores of 60-63, and the clinical range consists of T-scores greater than 63.
Measured: 4 years post-intervention
Parent Sensitivity
The outcome measure reported is the parent sensitivity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-115. A higher score indicates a higher level of parent sensitivity from caregiver to child.
Measured: 4 years post-intervention
Child Social Involvement
The outcome measure reported is the child social involvement score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-70. A higher score indicates a higher level of child social involvement from caregiver to child.
Measured: 4 years post-intervention
Child Negative Emotionality
The outcome measure reported is the child negative emotionality score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-30. A higher score indicates a higher level of child negative emotionality from child.
Measured: 4 years post-intervention
Dyadic Negative States
The outcome measure reported is the dyadic negative states score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-10. A higher score indicates a higher level of dyadic negative states between caregiver and child.
Measured: 4 years post-intervention
Dyadic Reciprocity
The outcome measure reported is the dyadic reciprocity score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-15. A higher score indicates a higher level of dyadic reciprocity between caregiver and child.
Measured: 4 years post-intervention
Parent Limit Setting
The outcome measure reported is the parent limit setting score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-35. A higher score indicates a higher level of parent limit setting from caregiver.
Measured: 4 years post-intervention
Child Compliance
The outcome measure reported is the child compliance score of the Coding Interactive Behavior (CIB) global rating scheme, during a challenge task and a social interaction task. Scores have a possible range of 1-20. A higher score indicates a higher level child compliance.
Measured: 4 years post-intervention
Parent Baseline RSA
The outcome measure is the average respiratory sinus arrhythmia (RSA) during the baseline task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating greater variability between interbeat intervals during the task.
Measured: 4 years post-intervention
Child Baseline RSA
The outcome measure is the average respiratory sinus arrhythmia (RSA) during the baseline task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating greater variability between interbeat intervals during the task.
Measured: 4 years post-intervention
RSA Synchrony Challenge Task
Respiratory sinus arrhythmia (RSA)
Measured: 4 years post-intervention
RSA Lead/Lag During Challenge Task
Respiratory sinus arrhythmia (RSA)
Measured: 4 years post-intervention
Parent RSA During Challenge Task
The outcome measure is the average respiratory sinus arrhythmia (RSA) during the challenge task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task.
Measured: 4 years post-intervention
Child RSA During Challenge Task
The outcome measure is the average respiratory sinus arrhythmia (RSA) during the challenge task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task.
Measured: 4 years post-intervention
RSA Synchrony During Social Interaction Task
Respiratory sinus arrhythmia (RSA)
Measured: 4 years post-intervention
RSA Lead/Lag During Social Interaction Task
Respiratory sinus arrhythmia (RSA)
Measured: 4 years post-intervention
Parent RSA During Social Interaction Task
The outcome measure is the average respiratory sinus arrhythmia (RSA) during the social interaction task for the caregiver. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task.
Measured: 4 years post-intervention
Child RSA During Social Interaction Task
The outcome measure is the average respiratory sinus arrhythmia (RSA) during the social interaction task for the child. RSA is a biomarker that typically ranges from 1-10 depending on the participant's physiology, with a higher number indicating more variability in time between each heartbeat during the task.
Measured: 4 years post-intervention
Child - Cognitive Flexibility
The outcome measure is the age-corrected scale score of cognitive flexibility (Dimensional Change Card Sort) computed by the NIH Toolbox software. The score is standardized such that the mean score in the overall population is 100 and the standard deviation is 15, with scores above 100 being above the average performance for children of the indicated age.
Measured: 4 years post-intervention
Child - Delay Time
Behavioral inhibitory control/ marshmallow task
Measured: 4 years post-intervention
Child - Executive Function
The outcome measure is the age-corrected scale score of executive function (Flanker Inhibitory Control and Attention Test) computed by the NIH Toolbox software. The score is standardized such that the mean score in the overall population is 100 and the standard deviation is 15, with scores above 100 being above the average performance for children of the indicated age.
Measured: 4 years post-intervention
Child - Distraction Strategy
Behavioral inhibitory control/ marshmallow task
Measured: 4 years post-intervention
Child - Distress Level
Behavioral inhibitory control/ marshmallow task
Measured: 4 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start5 Nov 2014
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ParentingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Vanderbilt University Medical Center, Boston College
- Responsible party
- Sponsor
- Investigators
- Catherine A Taylor, PhD, Principal investigator, Boston College School of Social WorkJulia M Fleckman, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059185
- Sponsor's protocol ID
- 492966
- Other IDs
- R01HD093665
- Status last verified
- Sep 2024
- First submitted
- 31 Jul 2019
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment in a Selected Population
- ClinicalTrials.gov ID
- NCT04059185
- Acronym / sponsor ID
- 492966
- Conditions
- Parenting, Child Behavior, Child Rearing
- Keywords
- Child abuse, Child maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,133 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Vanderbilt University Medical Center, Boston College
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Universal and broad selective parenting education programs that improve parenting skills, increase parents' understanding of child development, and teach positive child discipline strategies can prevent use of corporal punishment and child physical maltreatment. The proposed research addresses this critical need by investigating brief, relatively low-resource intensive primary prevention parenting programs that can be disseminated widely. By reducing cumulative adverse childhood experiences, which include child physical maltreatment, these interventions are expected to reduce long-term health disparities and risks for major public health problems, such as violence, smoking, obesity, drug abuse, risky sexual behavior, mental health disorders, and heart disease, among others
Detailed description
- Study design Our long-term goal is to enlarge the evidence base for low resource-intensive and widely adaptable interventions that effectively target parenting outcomes to reduce risk of child physical abuse in settings with broad reach. The objective of this study is to test the effectiveness of two such interventions in promoting effective parenting and reducing child physical abuse risk as compared with "usual care" parenting education. The central hypothesis is that each of two brief interventions, Triple P-L2 and Play Nicely, will be more effective in improving parenting effectiveness and reducing child behavioral and emotional problems than the "usual care" condition. Full scale Triple-P is an evidence-based, five-level system of interventions shown to reduce risk for child maltreatment when all 5 levels are implemented. However, implementation of a single level would be much less costly, more easily disseminated, and might in itself reduce risk in a broader population. Play Nicely is a brief computer-based intervention that has shown preliminary evidence for shifting attitudes about use of physical discipline when implemented in a pediatric primary care setting. However, it has yet to be tested within a large randomized-controlled trial (RCT). The rationale for this study is to be able to inform policy for parent service or clinic centers serving high-volumes of parents that are interested in adopting relatively low-resource intensive interventions in order to reduce risk of child physical abuse and improve child health and development trajectories. This is a community-based RCT. Parents (n=1200) with children 2 to 7 years of age will be recruited from local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics and by open recruitment. Once consented, they will be enrolled, a baseline interview will be conducted, and they will be randomly assigned to one of 3 conditions: (1) Triple P-Level 2 only (L2) intervention, (2) Play Nicely intervention, or (3) a "usual care" control group. Three months later, a follow-up interview will be conducted in order to test for intervention effects. In addition, a long term follow-up will be conducted to test sustained effects of the intervention. Participants' children (n=1200) will be enrolled for the long term follow-up. Children will be invited to participate in order for the adult participant to be observed interacting with the child in several very benign behavioral activities. Adult participants that do not want to enroll their child may participate in the long term follow-up survey which they will have previously consented to. Our study name for presentation in the local community is "Tulane Innovations in Positive Parenting Study" (TIPPS).
- Subject Population We will recruit a total number of 2400 participants for this study. We will recruit 1200 adult participants from City of New Orleans and Jefferson Parish WIC Clinics. During the long-term follow-up visit, one child for each adult with be enrolled (n=1200).
- Procedure
Recruitment: Recruitment has taken place in WIC clinic waiting rooms. If a parent is eligible and interested, the TIPPS Staff Member will then confirm that she has completed all necessary WIC documentation and that she is scheduled for a follow-up appointment with WIC before moving forward with consent and enrollment.
Baseline Interview: After the participant is taken through the informed consent process, a TIPPS Team Member will then conduct the Baseline interview. Once the Baseline Interview is complete (approximately 45 minutes), the participant will be informed of their random assignment to one of three conditions: (1) Triple P-Level 2, (2) Play Nicely, or (3) Control. The next procedure will then depend upon which of the three groups the person is assigned to. (See "Arms and Interventions" section for more details.) Debrief: Once both the Baseline Interview and the Intervention phase are complete, a TIPPS Team Member will schedule the 3-month Follow-Up Appointment, provide the control condition, provide an area-specific resource guide, and give the participant our incentive. The whole procedure (enrollment, baseline interview, intervention, and debrief) is expected to take no more than 2 hours.
3-Month Follow-Up Visit: If the participant has a WIC appointment, when they return to WIC for their 3-month visit and once they've completed their WIC documentation, a TIPPS Team Member will conduct the 3-month interview with them. This interview should take no more than 45 minutes. As with the baseline visit, childcare will be offered when available and the Suicide Risk Protocol will be followed if needed. In the event that the participant cannot return to the study site for their 3-month visit, the TIPPS team member will schedule the 3-Month interview as a phone interview. If the participant is unwilling or unable to complete the follow-up interview over the phone, a follow-up interview will be scheduled at a more convenient location for the participant, such as a local business or the participant's home.
The long term follow-up visit protocol described below is possible due to funding from NICHD which will fund this study from 7/2018 - 6/2023.
Long Term Follow-Up Visit : Participants will be asked to arrive at the research site with their child indicated as the index child in the baseline survey visit. A trained research team member will conduct the informed consent procedures followed at the baseline visit. If the adult participate does not want her child to participate, she may complete the long-term follow-up survey which she has consented to previously. If she agrees to participate and gives permission for her child to participate, she must review and sign a new consent form before participating in any Long Term Follow-Up activities. The informed consent form will be a record of the mother's agreement for both her and her child to participate. Upon completion of the informed consent process, a research assistant will conduct the Long Term Follow-Up interview with the adult participant. A separate research assistant will engage the child participant in several tasks. The first task will be the NIH Toolbox, which measures Cognitive flexibility and executive function, administered by tablet. Next, the child will be given the Marshmallow Test, which is an inhibitory control task where the child is told to wait for to eat a marshmallow until the research assistant returns to the room, and if they are able to wait, they will get two marshmallows. The time before the child eats the marshmallow is a validated measure of inhibitory control; inhibitory control has been found to be a significant predictor of child health and development outcomes across the life course.
Following the surveys, ECG data will be collected on the child and mother concurrently, acquired using Mindware Technologies mobile recorders, and transmitted via wireless signals to a computer monitored by a research assistant. After participant and child leads have been connected to ECG machines, the participant and child will do 3 very benign behavioral activities together: 1) watch a short video, 2) tell a story together, and 3) engage in a cooperative task (drawing with an Etch A Sketch). Interactions will be video recorded with parental consent and child assent and coding of parent and child behaviors will be done using the coding interactive behavior (CIB) coding system. Respiratory Sinus Arrhythmia (RSA) values will be processed in 30-second epochs across tasks for mothers and for children, and multilevel growth models will be built examining each 30-second epoch over the course of the task, relative to the individuals' baseline RSA. Dr. Drury will have full oversight of the dyadic coding of video recorded interactions between mother and child. Lastly, a TIPPS Team Member will provide the participant with locally-based health care resources guide.
- Benefits
There will be no direct benefits to subjects for participating in this research, but the knowledge gained from the study may benefit society in general. Anticipated benefits might include a participant's greater understanding of positive parenting techniques.
- Costs
There will be no costs to the subject for participating in this research study.
- Alternatives
Subjects always have the option to not participate in the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Program 1 | Experimental | Other: Triple P-Level 2Triple P-Level 2 (TPL2), parenting education and consultation |
| Program 2 | Experimental | Other: Play NicelyPlay Nicely (PN), multimedia, computer-based parenting education |
| Control | Placebo comparator | Other: Usual careOur "usual care" control group participants receive a resource and referral list for local social services |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Women
- English-speaking
- adults, age 18 or older
- a parent of at least one child between 2 and 7 years of age
- a primary caregiver of that child
Key exclusion criteria (1 listed)
- anyone who does not meet the above inclusion criteria
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 |
|---|---|---|
| Triple P-Level 2Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice. | Other | Program 1 |
| Play NicelyPlay Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered "Great options," "Good options after others have been tried," or "There are better options." The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes. | Other | Program 2 |
| Usual careOur "usual care" control group participants receive a resource and referral list for local social services | Other | Control |
Primary outcome
Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
The measure was collected at baseline, 3 month post-intervention, and 4 year post-intervention. This question asks participants "How often on average in the past month have you spanked your child?" with seven categories: 0) never, 1) once or twice in the past month, 2) about once a week, 3) about twice a week, 4) about once every other day, 5) about once a day, and 6) more than once a day. Using the 0-6 score response range, the outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates decrease in frequency of spanking at the post-intervention timepoint.
Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
The Attitudes Towards Spanking (ATS) scale was collected at baseline, 3 months post-intervention, and 4 years post-intervention. The scale score response range was 0-28, with a higher number being stronger support for spanking. This change outcome was calculated by subtracting the baseline score from the 3 month or 4 year post-intervention score, such that a negative score indicates a decrease in approval of spanking at the post-intervention time point.
25 secondary outcomes
Parent - Child Discipline Practices
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
Child - Behavioral and Emotional Adjustment
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
Child - Externalizing, Internalizing, and Total Symptoms
Time frame: 4 years post-intervention
Parent Sensitivity
Time frame: 4 years post-intervention
Child Social Involvement
Time frame: 4 years post-intervention
Child Negative Emotionality
Time frame: 4 years post-intervention
Dyadic Negative States
Time frame: 4 years post-intervention
Dyadic Reciprocity
Time frame: 4 years post-intervention
Parent Limit Setting
Time frame: 4 years post-intervention
Child Compliance
Time frame: 4 years post-intervention
Parent Baseline RSA
Time frame: 4 years post-intervention
Child Baseline RSA
Time frame: 4 years post-intervention
RSA Synchrony Challenge Task
Time frame: 4 years post-intervention
RSA Lead/Lag During Challenge Task
Time frame: 4 years post-intervention
Parent RSA During Challenge Task
Time frame: 4 years post-intervention
Child RSA During Challenge Task
Time frame: 4 years post-intervention
RSA Synchrony During Social Interaction Task
Time frame: 4 years post-intervention
RSA Lead/Lag During Social Interaction Task
Time frame: 4 years post-intervention
Parent RSA During Social Interaction Task
Time frame: 4 years post-intervention
Child RSA During Social Interaction Task
Time frame: 4 years post-intervention
Child - Cognitive Flexibility
Time frame: 4 years post-intervention
Child - Delay Time
Time frame: 4 years post-intervention
Child - Executive Function
Time frame: 4 years post-intervention
Child - Distraction Strategy
Time frame: 4 years post-intervention
Child - Distress Level
Time frame: 4 years post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Catherine A Taylor, PhD principal investigator
Boston College School of Social Work
Julia M Fleckman, PhD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple P-Level 2 and Play Nicely in people with Parenting and Child Behavior, run by Tulane 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 11 inclusion and 1 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 20 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up (time frame: Baseline, 3 months post-intervention, 4 years post-intervention). The study lists 2 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 20 Dec 2024.