NCT03162822

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

May 19, 2017

Last Update Submit

November 11, 2020

Conditions

Keywords

Caregiver-Child CoercionEarly Childhood Caries

Outcome Measures

Primary Outcomes (4)

  • 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

  • Health Behaviors

    Health Behaviors

    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.

    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.

    30 Minutes per visit

Secondary Outcomes (1)

  • Psychophysiological Measures

    2-3 hours per visit

Study Arms (4)

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.

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.

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.

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).

Other: Evaluative Conditioning

Interventions

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.

Behavioral 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.

Cognitive 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.

Interpretation Bias Intervention

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).

Evaluative Conditioning Intervention

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Richard Heyman, Ph.D.

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Within-subject design over 2 visits
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

May 1, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations