THRIVE BY 3 Daycare to Promote Development/ Mental Health in 1&2 Year-olds

NCT03879733 | Completed

• 1 other identifier: 260624
• Study Type: interventional
• Target: 1,531
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluates a preventive, knowledge enhancement and tailored quality building intervention to promote development and mental health in 1 and 2 year-olds. Half of the participating childcare centers will get the intervention (intervention group) and half will get the intervention after 1 year (waitlist-control).

Conditions

Childcare Quality; Child Development

Keywords

childcare; quality; universal prevention; mental health; well-being

Outcome Measures

Primary Outcomes (4)

• Classroom Assessment Scoring System - Toddler (CLASS) (la Paro, M., Hamre, B., & Pianta, R., 2012)

  CLASS is used to measure change in process quality from pre-intervention (baseline) to half way through the intervention (5 months) period, post-intervention (10 months) as well as at 12 months follow up (22 months). CLASS is a multidimensional observational measure of process quality in daycare, for toddlers. Trained observers observe each group of children and staff for 3 loops of 15 minutes. Quality is assessed along 8 dimensions and 2 quality domains. Scores are given on a scale from 1-7 with 7 indicating higher quality, except on the dimension negative climate, where 1 indicates higher quality. The dimension score of negative climate is reversed when domain scores are calculated. Scores of 1-2 indicates low quality, 3-5 mediocre, and 6-7 high. Scores for each cycles are calculated, and averaged to give the dimension scores. Domain scores are then calculated based on the averaged domain scores.

  Baseline, 5 months, 10 months and 22 months. Note: not possible at 22 months due to Covid-19

• Child Behavior Checklist for preschool children (CBCL)(Achenbach, T. M., 2000)

  100 item parent report of child behavioral, emotional and social problems. each item is rated as 0 (Not True),1 (Somewhat or Sometimes True), or 2 (Very True, or Often True). Low scores indicate fewer problems. The measure is used to measure change in problem behavior during the intervention period (from baseline to end of intervention), and used as an outcome measure at post intervention (10 months) to see whether children in childcare center where the quality has positively changed during the intervention period will have less problem behavior.

  Baseline, 10 months and 22 months (one year follow up)

• C- Teacher report form for preschool children (C-TRF)(Achenbach, T. M., 2000)

  100 item teacher report of child behavioral, emotional and social problems. Each item is rated as 0 (Not True),1 (Somewhat or Sometimes True), or 2 (Very True, or Often True). Low scores indicate fewer problems. The measure is used to measure change in problem behavior during the intervention period (from baseline to end of intervention), and used as an outcome measure at post intervention (10 months) to see whether children in childcare center where the quality has positively changed during the intervention period will have less problem behavior.

  Baseline, 10 months and 22 months (one year follow up)

• The Brief Infant-Toddler Social and emotional Assessment (BITSEA) (Briggs-Gowan, M. J., Carter A.S. , Irwin J.R., Wachtel K. & Cicchetti D.V., 2004)

  BITSEA is a 42 item instrument to assess social-emotional/behavioral problems and delays in social-emotional competence in toddlers. The BITSEA is completed both by parents and child care staff. We use BITSEA to measure change in problem behavior during the intervention period (from baseline to end of intervention), and BITSEA is also used as an outcome measure at post intervention (10 months) and at 12 months follow up (22 months) to see whether children in childcare centers where the quality has positively changed during the intervention period will have less problem behavior.

  Baseline, 10 months and 22 months (one year follow up)

Study Arms (2)

Intervention group

EXPERIMENTAL

The group of childcare centers that will receive the intervention during 10 months from sept 2018 - June 2019

Behavioral: Thrive by Three

Wait-list control

OTHER

Will receive no intervention and continue with business as usual during the primary intervention period Sept. 2018 - June 2019. Will receive the intervention from Sept. 2019 - June 2020.

Behavioral: Treatment as usual (TAU)

Interventions

Thrive by Three BEHAVIORAL

The intervention consists of the following components: 1. Measurement of daycare quality with CLASS (Classroom Assessment Scoring System) 3 times during the intervention period 2. Feedback to group staff on 8 CLASS-quality dimensions 3. Monthly supervision of staff on two levels: supervision of daycare staff, and supervision of supervisors 4. Competence building with all staff: 3 full training days, plus 2 extra training days for pedagogical leaders/supervisors 5. Written material to parents, supervisors, and staff 6. Web page for staff and parents: tf3.no

Intervention group

Treatment as usual (TAU) BEHAVIORAL

The wait-list control group will continue with their daily activities and work in the childcare as usual. The wait list control group will have received general information about the study prior to consenting, however no materials or are provided by project. The child-care centers in the control conditions will receive a gift certificate of 3000 Norwegian Crones (NOK) by the end of the intervention period.

Wait-list control

Eligibility Criteria

• Age: 12 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children: All children aged 12 months to 36 months attending one of the selected childcare-centers.
• Child care centers: Childcare centers with groups for children aged 12-36 months was selected within each municipality, after the municipalities had consented to participate in the study. Child care centers volunteered to participate in the study.

You may not qualify if:

• Children: None
• Child-Care centers: Child care centers in the selected municipalities with only children older than 36 months.

Sponsors & Collaborators

• Regionsenter for barn og unges psykiske helse: lead
• Norwegian University of Science and Technology: collaborator
• BI Norwegian Business School - Oslo campus: collaborator
• University of Washington: collaborator
• The Research Council of Norway: collaborator

Study Sites (3)

Regional center for child and adolescent mental health, Eastern and southern Norway

Oslo, Nydalen, 0484, Norway

Location

Norwegian Buisness School, BI

Oslo, 0442, Norway

Location

Norwegian university of Science and Technology (NTNU)

Trondheim, 7491, Norway

Location

Related Publications (2)

• Buoen ES, Lekhal R, Lydersen S, Berg-Nielsen TS, Drugli MB. Promoting the Quality of Teacher-Toddler Interactions: A Randomized Controlled Trial of "Thrive by Three" In-Service Professional Development in 187 Norwegian Toddler Classrooms. Front Psychol. 2021 Nov 18;12:778777. doi: 10.3389/fpsyg.2021.778777. eCollection 2021.

  PMID: 34867691 DERIVED

• Lekhal R, Drugli MB, Berg-Nielsen TS, Buoen ES. A Model of Intervention and Implementation of Quality Building and Quality Control in Childcare Centers to Strengthen the Mental Health and Development of 1-3-Year Olds: Protocol for a Randomized Controlled Trial of Thrive by Three. JMIR Res Protoc. 2020 Oct 13;9(10):e17726. doi: 10.2196/17726.

  PMID: 32773366 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Elisabet S. Buoen, PhD

  RegionsenterRBUP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participating child-care centers, staff, parents and children are blind to the study conditions prior to consenting. After randomization the participants know if they get the intervention or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical psychologist, PhD

Model Details: Participating childcare centers are randomized to either a wait list control- group or an intervention group. The wait-list control group will receive the intervention after 1 year.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: October 16, 2017
• Primary Completion: November 15, 2020
• Study Completion: December 31, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

NO (3)