Caregiver-Child Interaction and Health Behaviors

Early Childhood Caries Clinical Trial

Official title:

Targeting Parent-Child Coercion to Impact Health Behaviors and Regimen Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162822
• Other study ID #: 15-01081
• Secondary ID: 1UH2DE025980-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caregivers and their child are being asked to participate because the investigators are interested in typical caregiver-child interactions and health behaviors. In particular, the investigators are interested in different ways that caregivers react to and understand their young children's behavior, and their health behaviors.

Description:

If they decide to participate in this study, caregivers and their child will come visit the laboratory twice at times that are convenient for them. The first visit will take 2.5-3 hours and the second visit will take 2-2.5 hours, so the subject runners will ask them to schedule them at times when their child will be well-rested and fed prior to arrival.

Here is a list of activities that the subject runners will ask caregivers and their child to participate in. These activities will be video-recorded and recordings will be kept digitally on a secure password-protected server. A separate consent form for the video-recording will be provided and caregivers must consent to the video-recording if they wish to participate in this study. Video-recordings will be assigned a random subject ID number.

• Upon arrival at the laboratory during both visits, the subject runners will explain the tasks to caregivers and the subject runners will set them and their child up with the machine that allows us to measure heart rate and skin moisture. This means the subject runners will place nine sensors on their and their child's bodies. These sensors will be placed on the collar bones, the lower left rib cage, the upper and mid-chest, the upper and midback, and the palm of their and their child's non-dominant hand. Caregivers and their child will still be able to move freely around the room.

• Next, the subject runners will either:

• Conduct a short discussion where the subject runners will discuss caregivers' responses to their child's behavior or the intentions behind their child's behavior. A quarter of the research subjects in this study will complete a task where their responses to their child's behaviors are discussed and another quarter of the subjects will complete a task where the reasons for their child's behavior are discussed. Which type of discussion participants have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.

• Or have caregivers complete a short computerized activity where caregivers will look at a series of images and descriptions or will be asked to rate a series of images with facial expressions. A quarter of the research subjects in this study will complete a computerized activity where they will look at a series of images and descriptions and another quarter of the subjects will complete a computerized activity where they will rate a series of images with facial expressions. Which type of activity participants have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.

• After this brief discussion, the subject runners will have caregivers and their child complete a series of tasks that are the sorts of activities they might encounter in daily life. In the first task the subject runners will have caregivers direct their child to clean up toys. In the second task the subject runners will have their child play with some toys while they are occupied on their phone. In the third task the subject runners will give them questionnaires to complete while their child waits on a mat. All three of these tasks will take 25-30 minutes.

• After this task, the subject runners will either:

• Allow caregivers to have a break with their child. The subject runners will provide toys, drinks and snacks during the break. The subject runners will then ask caregivers to brush their child's teeth with a toothbrush that the subject runners provide, as they normally would.

• Or have caregivers complete a task where they will rate what they felt and thought during their interaction with their child while watching a video of their interaction.

• At the end of these tasks the subject runners will provide caregivers with the opportunity to discuss the visit, their child's behaviors, and any other questions or concerns they may have. The subject runners will not ask them to participate in any additional visits or questionnaires after their second visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

Inclusion Criteria:

• Children between 18 and 36 months of age

• The primary caregiver of the child must be 18 years of age or older

• The primary caregiver must be the child's legal guardian

• The child in the dyad must have history of early childhood caries (ECC), have a sibling with a history of ECC, or be at risk for ECC

• The child in the dyad must qualify on behavioral problems

Exclusion Criteria:

-If individuals do not meet the above criteria, they will be excluded from the study.

Related Conditions & MeSH terms

• Caregiver-Child Coercion
• Early Childhood Caries

Intervention

Behavioral:
• Behavioral Intervention
The behavioral intervention has the parents develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions.

Other:
• Cognitive Intervention
The cognitive intervention has parents come up with reasons why their children do things they don't like, until they come up with benign attributions for those behaviors.
• Interpretation Bias Intervention
The Interpretation Bias intervention has parents look at "morphed" facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry.
• Evaluative Conditioning
The Evaluative Conditioning intervention presents parents with pictures of ambiguous child faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., sweet; cooperative).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver-Child Interaction Tasks	The subject runners will have caregivers and their child complete a series of tasks that are the sorts of activities they might encounter in daily life. In the first task the subject runners will have caregivers direct their child to clean up toys. In the second task the subject runners will have their child play with some toys while they are occupied on their phone. In the third task the subject runners will give them questionnaires to complete while their child waits on a mat.	30 Minutes per visit
Primary	Health Behaviors	Health Behaviors	10 Minutes per visit
Primary	Tooth brushing Task	The subject runners will ask caregivers to brush their child's teeth with a toothbrush that the subject runners provide, as they normally would.	3 Minutes per visit
Primary	Video-Mediated Emotion Recall	The video-mediated recall procedure (Gottman & Levenson, 1985; Lorber, 2007) is a procedure by which parents and/or a member of a couple view a videotape of their interaction with their partner or child. While watching the video, they use a dial to rate their experienced emotion and/or cognitions moment-by- moment during the interaction task.	30 Minutes per visit
Secondary	Psychophysiological Measures	The subject runners will set them and their child up with the machine that allows us to measure heart rate and skin moisture. This means the subject runners will place nine sensors on their and their child's bodies. These sensors will be placed on the collar bones, the lower left rib cage, the upper and mid-chest, the upper and midback, and the palm of their and their child's non-dominant hand. Caregivers and their child will still be able to move freely around the room.	2-3 hours per visit