NCT05654116

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

December 1, 2022

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • Post-Training Scores on Ages and Stages Questionnaire: Social-Emotional, Daycare Provider-Report

    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

  • Post-Training Scores on Ages and Stages Questionnaire: Social-Emotional, Parent-Report

    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

  • Post-Training Scores on Strengths and Difficulties Questionnaire, Daycare Provider-Report

    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

  • Post-Training Scores on Strengths and Difficulties Questionnaire, Parent-Report

    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

  • Post-Training Scores on Child Behavior Checklist 1.5-5, Daycare Provider-Report

    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

  • +3 more secondary outcomes

Study Arms (2)

CIP training group

EXPERIMENTAL

Participants assigned to the CIP training group will receive either an individual 5-week CIP training or a pairwise 6-week CIP training, both with weekly sessions.

Behavioral: Caregiver Interaction Profile (CIP) training

Waiting-list control group

NO INTERVENTION

Participants assigned to the waiting-list control group will receive no intervention while data collection is ongoing; after data collection is finished they will also receive the CIP training.

Interventions

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.

CIP training group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • currently working as a professional daycare provider in a daycare center

You may not qualify if:

  • temporary staff in daycare on short-term contracts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Copenhagen

Copenhagen, 1353, Denmark

RECRUITING

Related Publications (7)

  • 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.

    PMID: 28490857BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 11699809BACKGROUND
  • 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.

    PMID: 29990685BACKGROUND
  • 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

    BACKGROUND
  • Reijman S, Christensen Vieira C, Wahl Haase T, Helmerhorst KOW, Pontoppidan M, Grosen SA, Egmose I, Rohder K, Skovgaard Vaever M. A randomized trial of the Caregiver Interaction Profile (CIP) training with childcare providers: the Copenhagen Daycare Project study protocol. BMC Psychol. 2024 Mar 6;12(1):127. doi: 10.1186/s40359-024-01568-1.

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Sophie Reijman, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Signe Petterson Platz, MA

CONTACT

Katrine Røhder, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Trained coders who code the outcome variables of the study (from video-recorded material) will be blind to the intervention vs control condition, and to the baseline vs follow-up condition.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 16, 2022

Study Start

August 1, 2021

Primary Completion

June 1, 2025

Study Completion

January 1, 2026

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations