Child Behavior, Child Rearing, Parenting
Conditions
Keywords
Child abuse, Child maltreatment
Brief 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. 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
1. 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). 2. 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). 3. 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. 4\. 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. 5\. Costs There will be no costs to the subject for participating in this research study. 6\. Alternatives Subjects always have the option to not participate in the research.
Interventions
OTHERTriple P-Level 2
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.
OTHERPlay Nicely
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.
OTHERUsual care
Our usual care control group participants receive a resource and referral list for local social services
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vanderbilt University Medical Center
Boston College
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * 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
Exclusion criteria
* anyone who does not meet the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child - Externalizing, Internalizing, and Total Symptoms | 4 years post-intervention | 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. |
| Parent Sensitivity | 4 years post-intervention | 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. |
| Child Social Involvement | 4 years post-intervention | 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. |
| Child Negative Emotionality | 4 years post-intervention | 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. |
| Dyadic Negative States | 4 years post-intervention | 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. |
| Dyadic Reciprocity | 4 years post-intervention | 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. |
| Parent Limit Setting | 4 years post-intervention | 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. |
| Child Compliance | 4 years post-intervention | 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. |
| Parent Baseline RSA | 4 years post-intervention | 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. |
| Child Baseline RSA | 4 years post-intervention | 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. |
| RSA Synchrony Challenge Task | 4 years post-intervention | Respiratory sinus arrhythmia (RSA) |
| Child - Behavioral and Emotional Adjustment | Baseline, 3 months post-intervention, 4 years post-intervention | 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. |
| Parent RSA During Challenge Task | 4 years post-intervention | 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. |
| Child RSA During Challenge Task | 4 years post-intervention | 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. |
| RSA Synchrony During Social Interaction Task | 4 years post-intervention | Respiratory sinus arrhythmia (RSA) |
| RSA Lead/Lag During Social Interaction Task | 4 years post-intervention | Respiratory sinus arrhythmia (RSA) |
| Parent RSA During Social Interaction Task | 4 years post-intervention | 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. |
| Child RSA During Social Interaction Task | 4 years post-intervention | 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. |
| Child - Cognitive Flexibility | 4 years post-intervention | 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. |
| Child - Delay Time | 4 years post-intervention | Behavioral inhibitory control/ marshmallow task |
| Child - Executive Function | 4 years post-intervention | 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. |
| Child - Distraction Strategy | 4 years post-intervention | Behavioral inhibitory control/ marshmallow task |
| Child - Distress Level | 4 years post-intervention | Behavioral inhibitory control/ marshmallow task |
| RSA Lead/Lag During Challenge Task | 4 years post-intervention | Respiratory sinus arrhythmia (RSA) |
| Parent - Child Discipline Practices | Baseline, 3 months post-intervention, 4 years post-intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Program 1 (Triple P-Level 2) Triple P-Level 2 (TPL2), parenting education and consultation
Triple P-Level 2: 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. | 353 |
| Program 2 (Play Nicely) Play Nicely (PN), multimedia, computer-based parenting education
Play Nicely: 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. | 343 |
| Control Our usual care control group participants receive a resource and referral list for local social services
Usual care: Our usual care control group participants receive a resource and referral list for local social services | 380 |
| Total | 1,076 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Longitudinal Assessment-Adults Only | Baseline survey incomplete | 4 | 8 | 3 |
| Longitudinal Assessment-Adults Only | Death | 4 | 4 | 3 |
| Longitudinal Assessment-Adults Only | Lost to Follow-up | 187 | 195 | 177 |
| Longitudinal Assessment-Adults Only | Protocol Violation | 11 | 13 | 13 |
| Longitudinal Assessment-Adults Only | Withdrawal by Subject | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Program 2 (Play Nicely) | Total | Control | Program 1 (Triple P-Level 2) |
|---|---|---|---|---|
| Age, Categorical Adults <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Adults >=65 years | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Age, Categorical Adults Between 18 and 65 years | 269 Participants | 817 Participants | 279 Participants | 269 Participants |
| Age, Categorical Index children <=18 years | 72 Participants | 253 Participants | 100 Participants | 81 Participants |
| Age, Categorical Index children >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Index children Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Adults Hispanic or Latino | 19 Participants | 56 Participants | 19 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Adults Not Hispanic or Latino | 197 Participants | 586 Participants | 195 Participants | 194 Participants |
| Ethnicity (NIH/OMB) Adults Unknown or Not Reported | 55 Participants | 181 Participants | 66 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Index children Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Index children Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Index children Unknown or Not Reported | 72 Participants | 253 Participants | 100 Participants | 81 Participants |
| Race (NIH/OMB) Adults American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Adults Asian | 1 Participants | 7 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Adults Black or African American | 232 Participants | 702 Participants | 239 Participants | 231 Participants |
| Race (NIH/OMB) Adults More than one race | 12 Participants | 34 Participants | 9 Participants | 13 Participants |
| Race (NIH/OMB) Adults Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Adults Unknown or Not Reported | 13 Participants | 33 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Adults White | 13 Participants | 45 Participants | 16 Participants | 16 Participants |
| Race (NIH/OMB) Index children American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index children Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index children Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index children More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index children Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index children Unknown or Not Reported | 72 Participants | 253 Participants | 100 Participants | 81 Participants |
| Race (NIH/OMB) Index children White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 343 participants | 1076 participants | 380 participants | 353 participants |
| Sex: Female, Male Adults Female | 271 Participants | 823 Participants | 280 Participants | 272 Participants |
| Sex: Female, Male Adults Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Index children Female | 40 Participants | 133 Participants | 54 Participants | 39 Participants |
| Sex: Female, Male Index children Male | 32 Participants | 120 Participants | 46 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 289 | 4 / 294 | 3 / 297 | 0 / 81 | 1 / 72 | 0 / 100 |
| other Total, other adverse events | 0 / 289 | 0 / 294 | 0 / 297 | 0 / 81 | 0 / 72 | 0 / 100 |
| serious Total, serious adverse events | 0 / 289 | 0 / 294 | 0 / 297 | 0 / 81 | 0 / 72 | 0 / 100 |
Outcome results
Primary
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.
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
Population: All available survey data for each time point was used. The baseline to 4 year post-intervention number analyzed differs from the baseline to 3 month post-intervention due to study attrition (lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | Baseline to 3 month post-intervention | -.86 score on a scale | Standard Deviation 5.8 |
| Program 1 (Triple P-Level 2) | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | Baseline to 4 years post-intervention | -1.8 score on a scale | Standard Deviation 6.6 |
| Program 2 (Play Nicely) | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | Baseline to 3 month post-intervention | -2.1 score on a scale | Standard Deviation 6 |
| Program 2 (Play Nicely) | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | Baseline to 4 years post-intervention | -2.5 score on a scale | Standard Deviation 7.1 |
| Control | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | Baseline to 3 month post-intervention | -.13 score on a scale | Standard Deviation 5 |
| Control | Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up | Baseline to 4 years post-intervention | -1.9 score on a scale | Standard Deviation 6.3 |
Primary
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.
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
Population: All available survey data for each time point was used. The baseline to 4 year post-intervention number analyzed differs from the baseline to 3 month post-intervention due to study attrition (lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | Baseline to 3 month post-intervention | -.32 score on a scale | Standard Deviation 1.6 |
| Program 1 (Triple P-Level 2) | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | Baseline to 4 years post-intervention | -.69 score on a scale | Standard Deviation 1.5 |
| Program 2 (Play Nicely) | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | Baseline to 3 month post-intervention | -.27 score on a scale | Standard Deviation 1.4 |
| Program 2 (Play Nicely) | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | Baseline to 4 years post-intervention | -.68 score on a scale | Standard Deviation 1.6 |
| Control | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | Baseline to 3 month post-intervention | -.17 score on a scale | Standard Deviation 1.4 |
| Control | Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up | Baseline to 4 years post-intervention | -.80 score on a scale | Standard Deviation 1.8 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child Baseline RSA | 7.01 ms^2 | Standard Deviation 1.15 |
| Program 2 (Play Nicely) | Child Baseline RSA | 6.93 ms^2 | Standard Deviation 1.11 |
| Control | Child Baseline RSA | 7.00 ms^2 | Standard Deviation 1.27 |
Secondary
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.
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
Population: All available survey data for each time point was used. The baseline, 3 month post-intervention, and 4 year post-intervention number analyzed differs due to study attrition (lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child - Behavioral and Emotional Adjustment | 4 years post-intervention | 17.2 score on a scale | Standard Deviation 12 |
| Program 1 (Triple P-Level 2) | Child - Behavioral and Emotional Adjustment | Baseline | 21 score on a scale | Standard Deviation 12.3 |
| Program 1 (Triple P-Level 2) | Child - Behavioral and Emotional Adjustment | 3 month post-intervention | 18.9 score on a scale | Standard Deviation 11.9 |
| Program 2 (Play Nicely) | Child - Behavioral and Emotional Adjustment | 4 years post-intervention | 19.3 score on a scale | Standard Deviation 13.8 |
| Program 2 (Play Nicely) | Child - Behavioral and Emotional Adjustment | Baseline | 21.5 score on a scale | Standard Deviation 12.5 |
| Program 2 (Play Nicely) | Child - Behavioral and Emotional Adjustment | 3 month post-intervention | 20.6 score on a scale | Standard Deviation 11.8 |
| Control | Child - Behavioral and Emotional Adjustment | 4 years post-intervention | 17.9 score on a scale | Standard Deviation 14.5 |
| Control | Child - Behavioral and Emotional Adjustment | Baseline | 20.8 score on a scale | Standard Deviation 12.8 |
| Control | Child - Behavioral and Emotional Adjustment | 3 month post-intervention | 20.6 score on a scale | Standard Deviation 12.6 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child - Cognitive Flexibility | 89.9 T-score | Standard Deviation 14.8 |
| Program 2 (Play Nicely) | Child - Cognitive Flexibility | 89.9 T-score | Standard Deviation 14.2 |
| Control | Child - Cognitive Flexibility | 88.8 T-score | Standard Deviation 14.7 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers reflect the child participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for child participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child Compliance | Challenge task at the 4 years post-intervention clinic visit | 14.87 score on a scale | Standard Deviation 2.57 |
| Program 1 (Triple P-Level 2) | Child Compliance | Social interaction task at the 4 years post-intervention clinic visit | 13.85 score on a scale | Standard Deviation 2.59 |
| Program 2 (Play Nicely) | Child Compliance | Challenge task at the 4 years post-intervention clinic visit | 15.35 score on a scale | Standard Deviation 2.01 |
| Program 2 (Play Nicely) | Child Compliance | Social interaction task at the 4 years post-intervention clinic visit | 14.24 score on a scale | Standard Deviation 2.61 |
| Control | Child Compliance | Challenge task at the 4 years post-intervention clinic visit | 15.19 score on a scale | Standard Deviation 2.05 |
| Control | Child Compliance | Social interaction task at the 4 years post-intervention clinic visit | 14.27 score on a scale | Standard Deviation 2.42 |
Secondary
Child - Delay Time
Behavioral inhibitory control/ marshmallow task
Time frame: 4 years post-intervention
Population: This test is only valid for children that have not yet begun first grade. Due to a later than expected commencement of our data collection at the 4 year post-intervention clinic visit, none of the children in our study met this requirement and hence the test was not administered.
Secondary
Child - Distraction Strategy
Behavioral inhibitory control/ marshmallow task
Time frame: 4 years post-intervention
Population: This test is only valid for children that have not yet begun first grade. Due to a later than expected commencement of our data collection at the 4 year post-intervention clinic visit, none of the children in our study met this requirement and hence the test was not administered.
Secondary
Child - Distress Level
Behavioral inhibitory control/ marshmallow task
Time frame: 4 years post-intervention
Population: This test is only valid for children that have not yet begun first grade. Due to a later than expected commencement of our data collection at the 4 year post-intervention clinic visit, none of the children in our study met this requirement and hence the test was not administered.
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child - Executive Function | 91.85 T-score | Standard Deviation 16 |
| Program 2 (Play Nicely) | Child - Executive Function | 85.8 T-score | Standard Deviation 16.5 |
| Control | Child - Executive Function | 90.3 T-score | Standard Deviation 14.1 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child - Externalizing, Internalizing, and Total Symptoms | 51.1 T-score | Standard Deviation 11 |
| Program 2 (Play Nicely) | Child - Externalizing, Internalizing, and Total Symptoms | 51.2 T-score | Standard Deviation 10.9 |
| Control | Child - Externalizing, Internalizing, and Total Symptoms | 51.3 T-score | Standard Deviation 13.3 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers reflect the child participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for child participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child Negative Emotionality | Challenge task at the 4 years post-intervention clinic visit | 8.43 score on a scale | Standard Deviation 2.44 |
| Program 1 (Triple P-Level 2) | Child Negative Emotionality | Social interaction task at the 4 years post-intervention clinic visit | 10.13 score on a scale | Standard Deviation 3.58 |
| Program 2 (Play Nicely) | Child Negative Emotionality | Challenge task at the 4 years post-intervention clinic visit | 8.01 score on a scale | Standard Deviation 1.93 |
| Program 2 (Play Nicely) | Child Negative Emotionality | Social interaction task at the 4 years post-intervention clinic visit | 9.77 score on a scale | Standard Deviation 3.18 |
| Control | Child Negative Emotionality | Challenge task at the 4 years post-intervention clinic visit | 8.21 score on a scale | Standard Deviation 2.04 |
| Control | Child Negative Emotionality | Social interaction task at the 4 years post-intervention clinic visit | 9.76 score on a scale | Standard Deviation 3.38 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child RSA During Challenge Task | 6.73 ms^2 | Standard Deviation 1.14 |
| Program 2 (Play Nicely) | Child RSA During Challenge Task | 6.72 ms^2 | Standard Deviation 0.99 |
| Control | Child RSA During Challenge Task | 6.63 ms^2 | Standard Deviation 1.23 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child RSA During Social Interaction Task | 6.76 ms^2 | Standard Deviation 1.12 |
| Program 2 (Play Nicely) | Child RSA During Social Interaction Task | 6.62 ms^2 | Standard Deviation 1.11 |
| Control | Child RSA During Social Interaction Task | 6.71 ms^2 | Standard Deviation 1.26 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers reflect the child participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for child participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Child Social Involvement | Challenge task at the 4 years post-intervention clinic visit | 46.16 score on a scale | Standard Deviation 6.66 |
| Program 1 (Triple P-Level 2) | Child Social Involvement | Social interaction task at the 4 years post-intervention clinic visit | 48.91 score on a scale | Standard Deviation 11.79 |
| Program 2 (Play Nicely) | Child Social Involvement | Challenge task at the 4 years post-intervention clinic visit | 47.39 score on a scale | Standard Deviation 6.84 |
| Program 2 (Play Nicely) | Child Social Involvement | Social interaction task at the 4 years post-intervention clinic visit | 50.18 score on a scale | Standard Deviation 11.54 |
| Control | Child Social Involvement | Challenge task at the 4 years post-intervention clinic visit | 47.27 score on a scale | Standard Deviation 6.23 |
| Control | Child Social Involvement | Social interaction task at the 4 years post-intervention clinic visit | 50.24 score on a scale | Standard Deviation 11.9 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers are adult-child dyads (n=236 total dyads, adults \[n=236\], and index children \[n=236\]) that completed the 4-year post-intervention clinic visit. No data is available for 17 dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Dyadic Negative States | Challenge task at the 4 years post-intervention clinic visit | 3.36 score on a scale | Standard Deviation 1.61 |
| Program 1 (Triple P-Level 2) | Dyadic Negative States | Social interaction task at the 4 years post-intervention clinic visit | 3.41 score on a scale | Standard Deviation 1.4 |
| Program 2 (Play Nicely) | Dyadic Negative States | Challenge task at the 4 years post-intervention clinic visit | 3.16 score on a scale | Standard Deviation 1.46 |
| Program 2 (Play Nicely) | Dyadic Negative States | Social interaction task at the 4 years post-intervention clinic visit | 3.37 score on a scale | Standard Deviation 1.54 |
| Control | Dyadic Negative States | Challenge task at the 4 years post-intervention clinic visit | 3.06 score on a scale | Standard Deviation 1.52 |
| Control | Dyadic Negative States | Social interaction task at the 4 years post-intervention clinic visit | 3.58 score on a scale | Standard Deviation 1.84 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers are adult-child dyads (n=236 total dyads, adults \[n=236\], and index children \[n=236\]) that completed the 4-year post-intervention clinic visit. No data is available for 17 dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Dyadic Reciprocity | Challenge task at the 4 years post-intervention clinic visit | 3.11 score on a scale | Standard Deviation 1.09 |
| Program 1 (Triple P-Level 2) | Dyadic Reciprocity | Social interaction task at the 4 years post-intervention clinic visit | 3.01 score on a scale | Standard Deviation 0.9 |
| Program 2 (Play Nicely) | Dyadic Reciprocity | Challenge task at the 4 years post-intervention clinic visit | 3.41 score on a scale | Standard Deviation 1.03 |
| Program 2 (Play Nicely) | Dyadic Reciprocity | Social interaction task at the 4 years post-intervention clinic visit | 3 score on a scale | Standard Deviation 0.94 |
| Control | Dyadic Reciprocity | Challenge task at the 4 years post-intervention clinic visit | 3.23 score on a scale | Standard Deviation 0.99 |
| Control | Dyadic Reciprocity | Social interaction task at the 4 years post-intervention clinic visit | 3.01 score on a scale | Standard Deviation 1.05 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent Baseline RSA | 6.01 ms^2 | Standard Deviation 1.48 |
| Program 2 (Play Nicely) | Parent Baseline RSA | 5.85 ms^2 | Standard Deviation 1.54 |
| Control | Parent Baseline RSA | 5.75 ms^2 | Standard Deviation 1.37 |
Secondary
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.
Time frame: Baseline, 3 months post-intervention, 4 years post-intervention
Population: All available survey data for each time point was used. The baseline, 3 month post-intervention, and 4 year post-intervention number analyzed differs due to study attrition (lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent - Child Discipline Practices | 3 month post-intervention | 45.1 score on a scale | Standard Error 5.3 |
| Program 1 (Triple P-Level 2) | Parent - Child Discipline Practices | Baseline | 44.1 score on a scale | Standard Error 4.9 |
| Program 1 (Triple P-Level 2) | Parent - Child Discipline Practices | 4 years post-intervention | 43.7 score on a scale | Standard Error 5.8 |
| Program 2 (Play Nicely) | Parent - Child Discipline Practices | 3 month post-intervention | 44.9 score on a scale | Standard Error 5.1 |
| Program 2 (Play Nicely) | Parent - Child Discipline Practices | Baseline | 44.1 score on a scale | Standard Error 4.8 |
| Program 2 (Play Nicely) | Parent - Child Discipline Practices | 4 years post-intervention | 44.2 score on a scale | Standard Error 5.7 |
| Control | Parent - Child Discipline Practices | Baseline | 45 score on a scale | Standard Error 4.6 |
| Control | Parent - Child Discipline Practices | 4 years post-intervention | 44.5 score on a scale | Standard Error 5.3 |
| Control | Parent - Child Discipline Practices | 3 month post-intervention | 44.7 score on a scale | Standard Error 4.9 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers reflect the 236 adult participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for adult participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent Limit Setting | Challenge task at the 4 years post-intervention clinic visit | 29.72 score on a scale | Standard Deviation 3.76 |
| Program 1 (Triple P-Level 2) | Parent Limit Setting | Social interaction task at the 4 years post-intervention clinic visit | 27.24 score on a scale | Standard Deviation 4.78 |
| Program 2 (Play Nicely) | Parent Limit Setting | Challenge task at the 4 years post-intervention clinic visit | 29.69 score on a scale | Standard Deviation 4.27 |
| Program 2 (Play Nicely) | Parent Limit Setting | Social interaction task at the 4 years post-intervention clinic visit | 27.86 score on a scale | Standard Deviation 4.51 |
| Control | Parent Limit Setting | Challenge task at the 4 years post-intervention clinic visit | 30.11 score on a scale | Standard Deviation 3.27 |
| Control | Parent Limit Setting | Social interaction task at the 4 years post-intervention clinic visit | 26.64 score on a scale | Standard Deviation 5.53 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent RSA During Challenge Task | 5.65 ms^2 | Standard Deviation 1.36 |
| Program 2 (Play Nicely) | Parent RSA During Challenge Task | 5.47 ms^2 | Standard Deviation 1.34 |
| Control | Parent RSA During Challenge Task | 5.45 ms^2 | Standard Deviation 1.3 |
Secondary
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.
Time frame: 4 years post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent RSA During Social Interaction Task | 5.95 ms^2 | Standard Deviation 1.31 |
| Program 2 (Play Nicely) | Parent RSA During Social Interaction Task | 5.76 ms^2 | Standard Deviation 1.49 |
| Control | Parent RSA During Social Interaction Task | 5.78 ms^2 | Standard Deviation 1.25 |
Secondary
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.
Time frame: 4 years post-intervention
Population: These numbers reflect the 236 adult participants within the adult-child dyads (n=236 total dyads) that completed the 4-year post-intervention clinic visit. No data is available for adult participants from 17 of the adult-child dyads because they did not consent to videotaped observation (n=11) or their data was invalid based on coding specifications (N=6).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Program 1 (Triple P-Level 2) | Parent Sensitivity | Challenge task at the 4 years post-intervention clinic visit | 67.34 score on a scale | Standard Deviation 14.82 |
| Program 1 (Triple P-Level 2) | Parent Sensitivity | Social interaction task at the 4 years post-intervention clinic visit | 72.75 score on a scale | Standard Deviation 15.48 |
| Program 2 (Play Nicely) | Parent Sensitivity | Challenge task at the 4 years post-intervention clinic visit | 68.43 score on a scale | Standard Deviation 14.23 |
| Program 2 (Play Nicely) | Parent Sensitivity | Social interaction task at the 4 years post-intervention clinic visit | 73.15 score on a scale | Standard Deviation 15.63 |
| Control | Parent Sensitivity | Challenge task at the 4 years post-intervention clinic visit | 69.03 score on a scale | Standard Deviation 14.49 |
| Control | Parent Sensitivity | Social interaction task at the 4 years post-intervention clinic visit | 70.68 score on a scale | Standard Deviation 18.5 |
Secondary
RSA Lead/Lag During Challenge Task
Respiratory sinus arrhythmia (RSA)
Time frame: 4 years post-intervention
Secondary
RSA Lead/Lag During Social Interaction Task
Respiratory sinus arrhythmia (RSA)
Time frame: 4 years post-intervention
Secondary
RSA Synchrony Challenge Task
Respiratory sinus arrhythmia (RSA)
Time frame: 4 years post-intervention
Secondary
RSA Synchrony During Social Interaction Task
Respiratory sinus arrhythmia (RSA)
Time frame: 4 years post-intervention