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

Child Development Clinical Trial

— Tb3  

Official title:

THRIVE BY 3 Preventive Knowledge Enhancement & Tailored Quality-building in Daycare to Promote Development/ Mental Health in 1&2 Year-olds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879733
• Other study ID #: 260624
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Regionsenter for barn og unges psykiske helse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Mental health problems manifest already in preschool age and continue into middle and late childhood. However, research strongly indicates that mental health problems appear even among 1-2 year olds. Because 80% of Norwegian under 3 years attend childcare, and stay there for long hours, interventions targeting caregiver-child interactions may prove an important avenue towards universal prevention of mental health problems. Since requirements for high quality is not sufficiently met in many Norwegian childcare centers today, a cost-efficient, sustainable model of intervention is called for to enhance and track the quality of childcare for 1-3 year olds. The investigators in the study will break new grounds by, conducting a cluster randomized control trial of a newly developed comprehensive intervention for promoting mental health among toddlers in childcare, the Thrive by Three. Because, high quality childcare is in a unique position to prevent developmental trajectories leading to mental health problems and to early identify children in need of help, effective quality enhancing interventions will be of great value for the Norwegian society, both on individual, family, community and national level. The primary objective of the project is thus to investigate whether the intervention Thrive by Three will improve childcare quality, and strengthen children's mental health and development. It is hypothesized that the intervention will prove superior to the wait-list control after the 10 month intervention period and at 12 months follow-up with respect to childcare quality and children's mental health, development and well-being. Our secondary objective is to investigate the cost-effectiveness of the intervention and whether effects are moderated by characteristics of the children, caregivers and/or implementation outcomes. In a subsample of approximately 300 children the investigators will sample cortisol at two time points (pre and post intervention) to investigate whether quality enhancement alters the cortisol level in children in childcare, compared to cortisol secretion at home. User perspectives and experience with Thrive by Three will be captured through qualitative interviews.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1531
• Est. completion date: December 31, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 35 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Child Development
• Childcare Quality

Intervention

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

Locations

Country	Name	City	State
Norway	Norwegian Buisness School, BI	Oslo
Norway	Regional center for child and adolescent mental health, Eastern and southern Norway	Oslo	Nydalen
Norway	Norwegian university of Science and Technology (NTNU)	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Regionsenter for barn og unges psykiske helse	BI Norwegian Business School - Oslo campus, Norwegian University of Science and Technology, The Research Council of Norway, University of Washington

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)