Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment

Not Applicable

Completed

Conditions: Parenting
Child Rearing
Child Behavior

Interventions: Other: Usual care
Other: Triple P-Level 2
Other: Play Nicely

Registration Number: NCT04059185

Lead Sponsor: Tulane University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1133

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Usual care	Our "usual care" control group participants receive a resource and referral list for local social services
Program 1	Triple P-Level 2	Triple P-Level 2 (TPL2), parenting education and consultation
Program 2	Play Nicely	Play Nicely (PN), multimedia, computer-based parenting education

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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)
RSA Lead/Lag During Challenge Task	4 years post-intervention	Respiratory sinus arrhythmia (RSA)
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