Clinical trial NCT04059185: Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment
Official title: Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment in a Selected Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Child Behavior
Child Rearing
Keywords: Child abuse
Child maltreatment
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Vanderbilt University Medical Center
name: Boston College
First posted: 2019-08-16
Enrollment: 1133
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent - Change From Baseline Frequency of Corporal Punishment Use at 3 Months and at Long-term Follow-up
timeFrame: Baseline, 3 months post-intervention, 4 years post-intervention
measure: Parent - Change From Baseline Attitudes Toward Use of Corporal Punishment at 3 Months and at Long-term Follow-up
timeFrame: Baseline, 3 months post-intervention, 4 years post-intervention
Secondary outcomes:
measure: Parent - Child Discipline Practices
timeFrame: Baseline, 3 months post-intervention, 4 years post-intervention
measure: Child - Behavioral and Emotional Adjustment
timeFrame: Baseline, 3 months post-intervention, 4 years post-intervention
measure: Child - Externalizing, Internalizing, and Total Symptoms
timeFrame: 4 years post-intervention
measure: Parent Sensitivity
timeFrame: 4 years post-intervention
measure: Child Social Involvement
timeFrame: 4 years post-intervention
measure: Child Negative Emotionality
timeFrame: 4 years post-intervention
measure: Dyadic Negative States
timeFrame: 4 years post-intervention
measure: Dyadic Reciprocity
timeFrame: 4 years post-intervention
measure: Parent Limit Setting
timeFrame: 4 years post-intervention
measure: Child Compliance
timeFrame: 4 years post-intervention
measure: Parent Baseline RSA
timeFrame: 4 years post-intervention
measure: Child Baseline RSA
timeFrame: 4 years post-intervention
measure: RSA Synchrony Challenge Task
timeFrame: 4 years post-intervention
measure: RSA Lead/Lag During Challenge Task
timeFrame: 4 years post-intervention
measure: Parent RSA During Challenge Task
timeFrame: 4 years post-intervention
measure: Child RSA During Challenge Task
timeFrame: 4 years post-intervention
measure: RSA Synchrony During Social Interaction Task
timeFrame: 4 years post-intervention
measure: RSA Lead/Lag During Social Interaction Task
timeFrame: 4 years post-intervention
measure: Parent RSA During Social Interaction Task
timeFrame: 4 years post-intervention
measure: Child RSA During Social Interaction Task
timeFrame: 4 years post-intervention
measure: Child - Cognitive Flexibility
timeFrame: 4 years post-intervention
measure: Child - Delay Time
timeFrame: 4 years post-intervention
measure: Child - Executive Function
timeFrame: 4 years post-intervention
measure: Child - Distraction Strategy
timeFrame: 4 years post-intervention
measure: Child - Distress Level
timeFrame: 4 years post-intervention
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
affiliation: Boston College School of Social Work
name: Catherine A Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Julia M Fleckman, PhD
role: PRINCIPAL_INVESTIGATOR
References: