Parental Presence and Preschoolers' Behavior

• ClinicalTrials.gov Identifier: NCT04580316
• Recruitment Status: Completed
• First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Sponsor: Alexandria University
• Information provided by (Responsible Party): Dina Youssef Attia, Alexandria University

Study Description

Brief Summary:

Purpose: This study aimed to assess the effect of parental active/passive presence technique (PAP/PPP) on the overall behavior of preschool children with different intelligence and fear levels.

Methods: This randomized controlled trial recruited 150 healthy children, 3-6 years old, with no history of previous dental pain/treatment, IQ level ≤70 to ≤110. After sample collection, in the first visit, children were stratified according to their Intelligence Quotient into 3 equal groups (high, average, low) in which each group was further equally and randomly divided into 2 sub-groups (test and control). In the second visit, before intervention with preventive measures, dental fear was assessed using facial image scale. During intervention, the control sub-groups were managed using PPP technique, while the test sub-groups were managed using PAP technique. Overall behavior was assessed using Frankl behavior rating scale at the end of the 2nd visit. Data was analyzed using chi-square test and logistic regression analysis.

Results: The PAP technique had significantly higher odds of positive behavior than the PPP technique (P=0.002).

Conclusions: Children with low intelligence showed higher dental fear and negative behavior in the dental setting. PAP technique had significant positive effect on the children's overall behavior with different fear and intelligence levels.

Condition or disease	Intervention/treatment	Phase
Parent-Child Relations; Dental Fear	Behavioral: Parental active presence; Behavioral: Parent passive presence	Not Applicable

Detailed Description:

The design of the study was a randomized controlled clinical trial with an allocation ratio of 1:1. Children enrolled in this study were stratified based on their IQ into three groups; high, average and low IQ groups. In each of these three groups, children were randomly and equally allocated into study and control subgroups. Thus, this study included 6 subgroups.

- Visual Screening and History taking were carried out to identify children who fulfilled the inclusion criteria. Parental meeting was also conducted to explain the child entire research plan.

The children were recruited from the Outpatient clinic of Pediatric Dentistry Department in Faculty of Dentistry at Alexandria University.

The IQ test for each selected child took place in a quiet closed room (special need clinic). The preventive measures were applied in the pediatric clinic of the department.

- Interventions

In the first visit, children who fulfilled the inclusion/ exclusion criteria were evaluated by IQ test then divided into 3 equal groups (50 children) according to their level of intelligence IQ as follows:

1. High IQ Children group (HIQ): with score of (110 and above)
2. Average IQ Children (AIQ): with score of (90-109)

3. Low IQ Children (LIQ)(with the normal intelligence range): with score of (70-89) In the second visit, fear was measured in each group followed by random allocation into test and control subgroups and then the implementation of the intervention.

   • In each group (50 children), 25 children in subgroup S (study group) were managed using Parental Active Presence (PAP) technique, while the other 25 children in subgroup C (control group) were managed using Parental Passive Presence (PPP) technique. Parental Active / Passive Presence technique was accompanied with Tell-Show-Do (TSD) Technique (Addelston, 1959). During this management, dental preventive measures were applied.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Only biostatistician was blinded
• Primary Purpose: Other
• Official Title: Active/Passive Parental Presence Influences Behavior of Preschoolers With Different Intelligence and Fear Levels in the Dental Setting: Randomized Clinical Trial
• Actual Study Start Date: December 20, 2017
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: August 19, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental group; 75 children were managed during intervention using Parental Active Presence.	Behavioral: Parental active presence; The parents were allowed to stand close to their children, do handholding, eye contacting and help in explaining the dentist's instructions.
Placebo Comparator: control group; 75 children were managed with passive parent presence.	Behavioral: Parent passive presence; Parents were instructed to sit silently in the dental clinic behind the patient with no eye contact, and without a spoken word only to reassure their children

Outcome Measures

Primary Outcome Measures :

1. Overall Behavior [ Time Frame: 1 month ]
   Frankl's Behavior Rating Scale (FBRS) (Frankl, Shiere and Fogels, 1962) At the end of the second visit, after the application of preventive measures, each child overall behavior in each group was evaluated according to Frankl's Behavior Rating Scale (FBRS). It is a four group scale used to assess and evaluate the behavior of a child starting from Rating no. 1 (- -) with the most negative child behavior to Rating no. 4 (++) with the most positive child behavior.
2. Fear Measure [ Time Frame: 1 month ]

   Facial Image Scale (FIS) (Buchanan and Niven, 2002) to account for fear state and is entered into the analysis as a confounder.

   Dental fear was measured in the second visit by administration of Facial Image Scale (FIS). This measurement was done to every child in each group before the start of dental treatment. It is comprised of a row of five faces ranging from very happy face to very unhappy one. Children were asked to point at which face they feel most like at that moment. The face is scored by giving a value of one to the most positive affect face and five to the most negative affect face. The faces with 1 and 2 indicated a low dental fear , while the faces with the value of 4 and 5 indicated high dental fear

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ranging from 3-6 years (the preoperational stage) (Piaget, 1954; 1966).
2. Patients with no history of previous dental treatment and no history of dental pain.
3. Patients with at least one sound quadrant for sealant application.
4. Patients IQ level should be in the normal intelligence range.

Exclusion Criteria:

1. Multiple dental problems with pain.
2. History of previous dental therapy
3. History of medical and psychological problems
4. Any degree of intellectual disability

Contacts and Locations

Locations

Egypt

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Sponsors and Collaborators

Alexandria University

Investigators

• Principal Investigator: Karin M. Dowidar, PhD; Alexandria University

More Information

Publications:

Shetty RM, Pashine A, Jose NA, Mantha S. Role of Intelligence Quotient (IQ) on anxiety and behavior in children with hearing and speech impairment. Spec Care Dentist. 2018 Jan;38(1):13-18. doi: 10.1111/scd.12264. Epub 2018 Jan 4.

Piira T, Sugiura T, Champion GD, Donnelly N, Cole AS. The role of parental presence in the context of children's medical procedures: a systematic review. Child Care Health Dev. 2005 Mar;31(2):233-43. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

AlDhelai TA, Khalil AM, Elhamouly Y, Dowidar KML. Influence of active versus passive parental presence on the behavior of preschoolers with different intelligence levels in the dental operatory: a randomized controlled clinical trial. BMC Oral Health. 2021 Aug 28;21(1):420. doi: 10.1186/s12903-021-01781-z.

• Responsible Party: Dina Youssef Attia, Assistant lecturer, Alexandria University
• ClinicalTrials.gov Identifier: NCT04580316
• Other Study ID Numbers: Parent active/passive presence
• First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We will share the study protocol
• Supporting Materials: Study Protocol
• Time Frame: After 1 month and for 1 year
• Access Criteria: Request access

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina Youssef Attia, Alexandria University:

Dental fear; Intelligence quotient; Preschool children; Parental technique; Behavior modification