Childcare QualityTb3NCT03879733
THRIVE BY 3 Daycare to Promote Development/ Mental Health in 1&2 Year-olds
A study testing Thrive by Three and Treatment as usual (TAU) in people with Childcare Quality and Child Development, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Childcare Quality, Child Development
- What is being tested?
- Thrive by Three and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,531 participants
- Where
- 3 sitesNorway
- Study dates
- 16 Oct 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children: None
- Child-Care centers: Child care centers in the selected municipalities with only children older than 36 months.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Regional center for child and adolescent mental health, Eastern and southern Norway
Oslo, Nydalen, 0484
Norwegian Buisness School, BI
Oslo, 0442
Norwegian university of Science and Technology (NTNU)
Trondheim, 7491
About this study
Official title: THRIVE BY 3 Preventive Knowledge Enhancement & Tailored Quality-building in Daycare to Promote Development/ Mental Health in 1&2 Year-olds
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).
Read the detailed 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.
- Conditions
- Childcare Quality, Child Development
- Being tested
- Thrive by Three, Treatment as usual (TAU)
- Keywords
- childcare, quality, universal prevention, mental health, well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrive by ThreeBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The group of childcare centers that will receive the intervention during 10 months from sept 2018 - June 2019 Receives: 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. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 10 months and 22 months (one year follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start16 Oct 2017
- Primary completion15 Nov 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childcare QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, BI Norwegian Business School - Oslo campus, University of Washington, The Research Council of Norway
- Responsible party
- Principal investigator, Elisabet Solheim Buøen, Regionsenter for barn og unges psykiske helse
- Investigators
- Elisabet S. Buoen, PhD, Principal investigator, RegionsenterRBUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879733
- Sponsor's protocol ID
- 260624
- Acronym
- Tb3
- Status last verified
- Apr 2022
- First submitted
- 13 Mar 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34867691Lekhal 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.
PubMed 32773366
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE BY 3 Preventive Knowledge Enhancement & Tailored Quality-building in Daycare to Promote Development/ Mental Health in 1&2 Year-olds
- ClinicalTrials.gov ID
- NCT03879733
- Acronym / sponsor ID
- Tb3 / 260624
- Conditions
- Childcare Quality, Child Development
- Keywords
- childcare, quality, universal prevention, mental health, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,531 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, BI Norwegian Business School - Oslo campus, University of Washington, The Research Council of Norway
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Thrive by ThreeThe group of childcare centers that will receive the intervention during 10 months from sept 2018 - June 2019 |
| Wait-list control | Other | Behavioral: Treatment as usual (TAU)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. |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Children: None
- Child-Care centers: Child care centers in the selected municipalities with only children older than 36 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrive by ThreeThe 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 | Behavioural | Intervention group |
| 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. | Behavioural | Wait-list control |
Primary outcome
Classroom Assessment Scoring System - Toddler (CLASS) (la Paro, M., Hamre, B., & Pianta, R., 2012)
Time frame: Baseline, 5 months, 10 months and 22 months. Note: not possible at 22 months due to Covid-19
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.
Child Behavior Checklist for preschool children (CBCL)(Achenbach, T. M., 2000)
Time frame: Baseline, 10 months and 22 months (one year follow up)
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.
C- Teacher report form for preschool children (C-TRF)(Achenbach, T. M., 2000)
Time frame: Baseline, 10 months and 22 months (one year follow up)
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.
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)
Time frame: Baseline, 10 months and 22 months (one year follow up)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 34867691Buoen 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.
- Derived from this study: PubMed 32773366Lekhal 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.
Related trials for Childcare Quality
Not yet recruiting
Nutrition Recommendation Intervention trialS in Children's Healthcare
Obesity, Childhood, Nutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabet S. Buoen, PhD principal investigator
RegionsenterRBUP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrive by Three and Treatment as usual (TAU) in people with Childcare Quality and Child Development, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classroom Assessment Scoring System - Toddler (CLASS) (la Paro, M., Hamre, B., & Pianta, R., 2012) (time frame: Baseline, 5 months, 10 months and 22 months. Note: not possible at 22 months due to Covid-19). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879733, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.