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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2021-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Childcare Quality Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Thrive by Three

Intervention Type 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

Wait-list control

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.

Group Type OTHER

Treatment as usual (TAU)

Intervention Type 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.

Interventions

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Thrive by Three

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 Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.