Early Childhood CariesNCT03162822
Caregiver-Child Interaction and Health Behaviors
A study testing Behavioral Intervention, Cognitive Intervention and Interpretation Bias Intervention in people with Early Childhood Caries and Caregiver-Child Coercion, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries, Caregiver-Child Coercion
- What is being tested?
- Behavioral Intervention, Cognitive Intervention and Interpretation Bias Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- -If individuals do not meet the above criteria, they will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Targeting Parent-Child Coercion to Impact Health Behaviors and Regimen Adherence
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.
Read the detailed 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.
- Conditions
- Early Childhood Caries, Caregiver-Child Coercion
- Being tested
- Behavioral Intervention, Cognitive Intervention, Interpretation Bias Intervention, Evaluative Conditioning
- Keywords
- Caregiver-Child Coercion, Early Childhood Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
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.
Cognitive InterventionOther
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 InterventionOther
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 ConditioningOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Intervention | Active comparator | 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. Receives: Other: Cognitive Intervention |
| Behavioral Intervention | Active comparator | 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. Receives: Behavioral: Behavioral Intervention |
| Interpretation Bias Intervention | Active comparator | 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. Receives: Other: Interpretation Bias Intervention |
| Evaluative Conditioning Intervention | Active comparator | 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). Receives: Other: Evaluative Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Minutes per visit
Health Behaviors
Health Behaviors
Measured: 10 Minutes per visit
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.
Measured: 3 Minutes per visit
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.
Measured: 30 Minutes per visit
Secondary outcomes (1)
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.
Measured: 2-3 hours per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 May 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within-subject design over 2 visits
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Richard Heyman, Ph.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162822
- Sponsor's protocol ID
- 15-01081
- Other IDs
- 1UH2DE025980-01
- Status last verified
- Nov 2020
- First submitted
- 19 May 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith Slep AM, Heyman RE, Mitnick DA, Lorber MF, Rhoades KA, Daly KA, Nichols SR, Eddy JM. Do Brief Lab-Based Interventions Decrease Coercive Conflict Within Couples and Parent-Child Dyads? Behav Ther. 2023 Jul;54(4):666-681. doi: 10.1016/j.beth.2023.01.006. Epub 2023 Feb 2.
PubMed 37330256
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Parent-Child Coercion to Impact Health Behaviors and Regimen Adherence
- ClinicalTrials.gov ID
- NCT03162822
- Acronym / sponsor ID
- 15-01081
- Conditions
- Early Childhood Caries, Caregiver-Child Coercion
- Keywords
- Caregiver-Child Coercion, Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Within-subject design over 2 visits
| Arm | Type | Receives |
|---|---|---|
| Cognitive Intervention | Active comparator | Other: Cognitive InterventionThe 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. |
| Behavioral Intervention | Active comparator | Behavioral: Behavioral InterventionThe behavioral intervention has the parents develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions. |
| Interpretation Bias Intervention | Active comparator | Other: Interpretation Bias InterventionThe 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 Intervention | Active comparator | Other: Evaluative ConditioningThe 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). |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -If individuals do not meet the above criteria, they will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionThe behavioral intervention has the parents develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions. | Behavioural | Behavioral Intervention |
| Cognitive InterventionThe 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. | Other | Cognitive Intervention |
| Interpretation Bias InterventionThe 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. | Other | Interpretation Bias Intervention |
| Evaluative ConditioningThe 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). | Other | Evaluative Conditioning Intervention |
Primary outcome
Caregiver-Child Interaction Tasks
Time frame: 30 Minutes per visit
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.
Health Behaviors
Time frame: 10 Minutes per visit
Health Behaviors
Tooth brushing Task
Time frame: 3 Minutes per visit
The subject runners will ask caregivers to brush their child's teeth with a toothbrush that the subject runners provide, as they normally would.
Video-Mediated Emotion Recall
Time frame: 30 Minutes per visit
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.
1 secondary outcome
Psychophysiological Measures
Time frame: 2-3 hours per visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 37330256Smith Slep AM, Heyman RE, Mitnick DA, Lorber MF, Rhoades KA, Daly KA, Nichols SR, Eddy JM. Do Brief Lab-Based Interventions Decrease Coercive Conflict Within Couples and Parent-Child Dyads? Behav Ther. 2023 Jul;54(4):666-681. doi: 10.1016/j.beth.2023.01.006. Epub 2023 Feb 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Heyman, Ph.D. principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Cognitive Intervention and Interpretation Bias Intervention in people with Early Childhood Caries and Caregiver-Child Coercion, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver-Child Interaction Tasks (time frame: 30 Minutes per visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.