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HealthyCDPNCT05654116

Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers

A study testing Caregiver Interaction Profile (CIP) training in people with Healthy and Emotion Regulation, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Healthy, Emotion Regulation, Language Development
What is being tested?
Caregiver Interaction Profile (CIP) training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteDenmark
Study dates
1 Aug 2021to 1 Jan 2026
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • temporary staff in daycare on short-term contracts

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Psychology, University of Copenhagen

    Copenhagen, 1353

Other trials in Denmark

About this study

Official title: The Copenhagen Daycare Project: Enhancing the Role of Daycare Providers in Supporting Young Children's Social and Emotional Development

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.

Being tested
Caregiver Interaction Profile (CIP) training
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver Interaction Profile (CIP) trainingBehavioural

    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.

Study groups in NCT05654116
Study groupRoleWhat they receive
CIP training groupExperimentalParticipants 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.
Receives: Behavioral: Caregiver Interaction Profile (CIP) training
Waiting-list control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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

  2. 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).

    Measured: 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

  3. 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).

    Measured: 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

  4. 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).

    Measured: 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

  5. 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).

    Measured: 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

  6. 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).

    Measured: 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)
  1. 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.

    Measured: 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

  2. 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.

    Measured: 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. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

    Measured: 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

  8. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start1 Aug 2021
  3. Primary completion1 Jun 2025
  4. Study completion1 Jan 2026

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654116
Sponsor's protocol ID
514-0217/21-2000
Acronym
CDP
Status last verified
May 2026
First submitted
1 Dec 2022
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28490857
  • 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.

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

  • 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.

    PubMed 11699809
  • 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.

    PubMed 29990685
  • 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

  • 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.

    PubMed 38449031

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver Interaction Profile (CIP) training in people with Healthy and Emotion Regulation, run by University of Copenhagen at 1 site in Denmark.

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 1 inclusion and 1 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

Post-Training Scores on CIP Scale Sensitive Responsiveness (time frame: 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). The study lists 6 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 NCT05654116, which also lists 7 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 22 May 2026.

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