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

Parenting Clinical Trial

Official title:

Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment in a Selected Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059185
• Other study ID #: 492966
• Secondary ID: R01HD093665
• Status: Completed
• Phase: N/A
• Start date: November 5, 2014
• Est. completion date: November 21, 2022

Study information

• Verified date: August 2023
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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 information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Child Rearing
• Parenting

Intervention

Other:
• 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.
• 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.
• Usual care
Our "usual care" control group participants receive a resource and referral list for local social services

Locations

Country	Name	City	State
United States	Tulane University School of Public Health and Tropical Medicine	New Orleans	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Tulane University	Boston College, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent - Change from baseline frequency of corporal punishment use at 3 months and at long-term follow-up	How often on average in the past month have you spanked your child?	Baseline, 3 months post-intervention, 4 years post-intervention
Primary	Parent - Change from baseline attitudes toward use of corporal punishment at 3 months and at long-term follow-up	Questions derived and modified from the Attitudes Toward Spanking (ATS) scale	Baseline, 3 months post-intervention, 4 years post-intervention
Secondary	Parent - child discipline practices	Parenting and Family Adjustment Scale (PAFAS)	Baseline, 3 months post-intervention, 4 years post-intervention
Secondary	Child - behavioral and emotional adjustment	Child Adjustment and Parent Efficacy Scale (CAPES)	Baseline, 3 months post-intervention, 4 years post-intervention
Secondary	Child - externalizing, internalizing, and total symptoms	Child Behavior Checklist (CBCL)	4 years post-intervention
Secondary	Parent & Child - parent sensitivity, child social involvement, child negative emotionality, dyadic reciprocity, dyadic negative states, parent limit setting, child compliance	Coding interactive behavior (CIB) coding system	4 years post-intervention
Secondary	Parent baseline RSA	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	Child baseline RSA	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	RSA synchrony challenge task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	RSA lead/lag during challenge task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	Parent RSA during challenge task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	Child RSA during challenge task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	RSA synchrony during social interaction task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	RSA lead/lag during social interaction task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	Parent RSA during social interaction task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	Child RSA during social interaction task	Respiratory sinus arrhythmia (RSA)	4 years post-intervention
Secondary	Child - cognitive flexibility	NIH Toolbox	4 years post-intervention
Secondary	Child - executive function	NIH Toolbox	4 years post-intervention
Secondary	Child - delay time	Behavioral inhibitory control/ marshmallow task	4 years post-intervention
Secondary	Child - distraction strategy	Behavioral inhibitory control/ marshmallow task	4 years post-intervention
Secondary	Child - distress level	Behavioral inhibitory control/ marshmallow task	4 years post-intervention