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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05654116
Other study ID # 514-0217/21-2000
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date January 2026

Study information

Verified date January 2024
Source University of Copenhagen
Contact Signe Petterson Platz, MA
Phone +4535327925
Email spp@psy.ku.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the Caregiver Interaction Profile (CIP) training program (Helmerhorst et al., 2017) promoting the relational quality between professional caregivers and children in daycare. The main questions it aims to answer are: - Does the CIP training program, compared to no training, improve the relational quality between daycare providers and children in daycare? - Does the CIP training program, compared to no training, foster children's social, emotional, and language development? Daycare providers assigned to the "training group" will participate in the CIP training program, which uses video-recorded interactions between the daycare providers and children in daycare to give feedback on the relational quality as observed in the videos. Daycare providers assigned to the "waiting list control group" will initially not take part in the training program but will receive the training after the study is finished. All daycare providers' daily interactions with the children in daycare will be filmed before and after the training in order to see if there has been a change in relational quality for the daycare providers in the training group (compared to the control group). Daycare providers in the training and control groups will also fill out questionnaires about the social, emotional, and language development of the children in their care. Researchers will compare daycare providers (and the children in their care) in the "training group" to daycare providers (and the children in their care) in the "control group" to see if the relational quality in the training group improves more than that in the control group as a result of the CIP training, and how that impacts the social, emotional, and language development of children.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 2026
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - currently working as a professional daycare provider in a daycare center Exclusion Criteria: - temporary staff in daycare on short-term contracts

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Caregiver Interaction Profile (CIP) training
The CIP training aims to boost six interactive skills in daycare providers: sensitive responsiveness, respect for children's autonomy, structuring and limit setting, verbal communication, developmental stimulation, and fostering positive peer interactions. The training takes place with 1 or 2 daycare providers at a time, and consists of 5 or 6 weekly sessions, respectively. In individual trainings, sessions 1-3 focus on two skills each, session 4 is a recap of two skills the daycare provider chooses, and the final session is shared with a colleague. In pairwise sessions, session 1 focuses on the first two skills, sessions 2-5 each focus on one skill, and the last session serves as a recap of two skills the daycare providers choose. The training uses a video-feedback method: daycare providers are filmed in interactions with children in daycare, the CIP trainer preselects relevant fragments of video recordings to discuss with the daycare provider(s) during the training sessions.

Locations

Country Name City State
Denmark Department of Psychology, University of Copenhagen Copenhagen

Sponsors (5)

Lead Sponsor Collaborator
University of Copenhagen Copenhagen Municipality, Denmark, University College Copenhagen, University of Groningen, VU University of Amsterdam

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Achenbach TM, Rescorla LA. Manual for the ASEBA Preschool Forms and Profiles. Burlington: University of Vermont, Research Center for Children, Youth, and Families; 2000.

Bleses D, Jensen P, Hojen A, Dale PS. An educator-administered measure of language development in young children. Infant Behav Dev. 2018 Aug;52:104-113. doi: 10.1016/j.infbeh.2018.06.002. Epub 2018 Jul 7. — View Citation

Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015. — View Citation

Helmerhorst KOW, Riksen-Walraven JMA, Fukkink RG, Tavecchio LWC, Gevers Deynoot-Schaub MJJM. Effects of the Caregiver Interaction Profile Training on Caregiver-Child Interactions in Dutch Child Care Centers: A Randomized Controlled Trial. Child Youth Care Forum. 2017;46(3):413-436. doi: 10.1007/s10566-016-9383-9. Epub 2016 Nov 30. — View Citation

Helmerhorst KOW, Riksen-Walraven JMA, Vermeer HJ, Fukkink RG, Tavecchio LWC. Measuring interactive skills of caregivers in child care centers: Development and validation of the caregiver interaction profile scales. Early Education and Development. 2014; 25(5): 770-790

Squires J, Bricker D, Heo K, Twombly E. Identification of social-emotional problems in young children using a parent-completed screening measure. Early Childhood Research Quarterly. 2001; 16(4): 405-419.

Outcome

Type Measure Description Time frame Safety issue
Primary Post-Training Scores on CIP Scale Sensitive Responsiveness The degree to which daycare providers respond promptly and appropriately to children's signals, coded using the Caregiver Interaction Profile scales (Helmerhorst et al., 2014), rated from 1 (low) to 7 (high). 9 weeks time frame between pre-training and post-training measurements for individual trainings; 10 weeks between pre-training and post-training measurements for pairwise trainings
Primary Post-Training Scores on CIP Scale Respect for Children's Autonomy The degree to which daycare providers are not intrusive but validate and encourage children's ideas, initiatives and intentions, coded using the Caregiver Interaction Profile scales (Helmerhorst et al., 2014), rated from 1 (low) to 7 (high). 9 weeks time frame between pre-training and post-training measurements for individual trainings; 10 weeks between pre-training and post-training measurements for pairwise trainings
Primary Post-Training Scores on CIP Scale Structuring and Limit Setting The degree to which daycare providers structure activities in a way that children can benefit, and communicate clearly to children what is expected of them and ensure they comply with the expectations, coded using the Caregiver Interaction Profile scales (Helmerhorst et al., 2014), rated from 1 (low) to 7 (high). 9 weeks time frame between pre-training and post-training measurements for individual trainings; 10 weeks between pre-training and post-training measurements for pairwise trainings
Primary Post-Training Scores on CIP Scale Verbal Communication The degree to which daycare providers verbally interact with children, and the quality of their interactions (incl form, tone, content), coded using the Caregiver Interaction Profile scales (Helmerhorst et al., 2014), rated from 1 (low) to 7 (high). 9 weeks time frame between pre-training and post-training measurements for individual trainings; 10 weeks between pre-training and post-training measurements for pairwise trainings
Primary Post-Training Scores on CIP Scale Developmental Stimulation The degree to which daycare providers stimulate children's personal competencies (incl cognitive, creative, motor development), coded using the Caregiver Interaction Profile scales (Helmerhorst et al., 2014), rated from 1 (low) to 7 (high). 9 weeks time frame between pre-training and post-training measurements for individual trainings; 10 weeks between pre-training and post-training measurements for pairwise trainings
Primary Post-Training Scores on CIP Scale Fostering Positive Peer Interactions The degree to which daycare providers facilitate and stimulate children interacting with each other in positive ways, such as helping, comforting, sharing, collaborating, coded using the Caregiver Interaction Profile scales (Helmerhorst et al., 2014), rated from 1 (low) to 7 (high). 9 weeks time frame between pre-training and post-training measurements for individual trainings; 10 weeks between pre-training and post-training measurements for pairwise trainings
Secondary Post-Training Scores on Ages and Stages Questionnaire: Social-Emotional, Daycare Provider-Report The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE; Squires et al., 2001) measures signs of disturbances in children's socio-emotional development; higher scores reflect more indications of socio-emotional disturbances in development. The ASQ:SE is filled out by children's daycare providers. Items describe socio-emotional behaviours, and daycare providers indicate whether these apply "most of the time", "sometimes", or "rarely or never". They can check the item if it presents a particular concern for them, which increases the overall score. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on Ages and Stages Questionnaire: Social-Emotional, Parent-Report The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE; Squires et al., 2001) measures signs of disturbances in children's socio-emotional development; higher scores reflect more indications of socio-emotional disturbances in development. The questionnaires are filled out by one of the children's parents. Items describe socio-emotional behaviours, and parents indicate whether these apply "most of the time", "sometimes", or "rarely or never". They can check the item if it presents a particular concern for them, which increases the overall score. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on Strengths and Difficulties Questionnaire, Daycare Provider-Report The Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001) has 25 items about positive and negative attributes in children, such as how children behave in social relationships. Daycare providers indicate for each item on a 3-point scale to what degree it applies to the child in question. A total difficulties score is calculated, and a prosocial behavour (strength) score. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on Strengths and Difficulties Questionnaire, Parent-Report The Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001) has 25 items about positive and negative attributes in children, such as how children behave in social relationships. Parents indicate for each item on a 3-point scale to what degree it applies to their child. A total difficulties score is calculated, and a prosocial behavour (strength) score. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on Child Behavior Checklist 1.5-5, Daycare Provider-Report The Child Behaviour Checklist 1.5-5 (CBCL 1.5-5; Achenbach & Rescorla, 2000) has 99 items measuring problem behavior in young children (such as "afraid to try new things"), with answer options "not true", "somewhat/sometimes true", and "very/often true". This questionnaire is filled out by daycare providers. Higher scores indicate higher levels of problem behavior. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on Child Behavior Checklist 1.5-5, Parent-Report The Child Behavior Checklist 1.5-5 (CBCL 1.5-5; Achenbach & Rescorla, 2000) has 99 items measuring problem behavior in young children (such as "afraid to try new things"), with answer options "not true", "somewhat/sometimes true", and "very/often true". This questionnaire is filled out by parents. Higher scores indicate higher levels of problem behavior. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on MacArthur Communicative Development Inventory-Short Form, Daycare Provider-Report The MacArthur Communicative Development Inventory-short, adapted for daycare (CDI-short; Bleses et al., 2018) has 70 vocabulary items, including animal sounds, body parts, and food and drink, which are checked by the daycare provider if they have heard the child produce the item, independent of pronunciation. More checks indicate more advanced communicative development. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
Secondary Post-Training Scores on MacArthur Communicative Development Inventory-Short Form, Parent-Report The MacArthur Communicative Development Inventory-short, adapted for daycare (CDI-short; Bleses et al., 2018) has 70 vocabulary items, including animal sounds, body parts, and food and drink, which are checked by parents if they have heard their child produce the item, independent of pronunciation. More checks indicate more advanced communicative development. 21 weeks time frame between pre-training and post-training assessments for individual trainings; 22 weeks time frame between pre-training and post-training assessments for pairwise trainings
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