Small Children, Big Emotions
Primary Purpose
Emotional Disturbances
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tuning in to Kids
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Disturbances
Eligibility Criteria
Inclusion Criteria:
- Referred children aged 2-5 years
- The child is enrolled in daycare
- The child is displaying problems with emotional dysregulation
Exclusion Criteria:
- Parent not sufficiently proficient in Norwegian Language to Complete assessment
- Child Protective Services have ongoing assessment where the outcome may be that the child will be placed in care outside of the home of the biological parent(s) or other current caregiver
- The child has already been diagnosed with an autism spectrum disorder
Sites / Locations
- BUP Øvre Romerike
- BUP Grorud
- Nic Waals Institutt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tuning in to Kids
Treatment as usual
Arm Description
Eight weekly two-hour sessions delivered in groups of up to six parents.
Treatment as usual, may consist of any psychosocial intervention the therapist sees fit, which is the type of intervention the participants ordinarily receives in the participating clinics. No limit on number of sessions or format of delivery.
Outcomes
Primary Outcome Measures
Coping with Toddlers' Negative Emotion Scale
A measure of parental behaviors in respond to toddlers' emotions. CTNES consists of 12 hypothetical situation where parents rate their likelihood of responding in six different ways on a scale from 1 (very unlikely) to 7 (very likely).
Secondary Outcome Measures
Full Information
NCT ID
NCT04108949
First Posted
September 26, 2019
Last Updated
December 20, 2022
Sponsor
University Hospital, Akershus
Collaborators
University of Oslo, University of Melbourne, Extrastiftelsen
1. Study Identification
Unique Protocol Identification Number
NCT04108949
Brief Title
Small Children, Big Emotions
Official Title
Tuning in to Kids: an Effectiveness Evaluation of Emotion Coaching to Parents and Daycare Teachers of At-risk Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to consequences of the Covid-19 pandemic, which made it impossible to complete the trial in a timely manner and in accordance with the study protocol
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
October 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
University of Oslo, University of Melbourne, Extrastiftelsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disturbances
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial with two arms.
Masking
Outcomes Assessor
Masking Description
Outcome assessors are blinded to treatment condition and receive no information about which treatment the participant will receive or have received.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tuning in to Kids
Arm Type
Experimental
Arm Description
Eight weekly two-hour sessions delivered in groups of up to six parents.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual, may consist of any psychosocial intervention the therapist sees fit, which is the type of intervention the participants ordinarily receives in the participating clinics. No limit on number of sessions or format of delivery.
Intervention Type
Behavioral
Intervention Name(s)
Tuning in to Kids
Intervention Description
A psychosocial intervention focusing on emotion socialization and emotion coaching.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
See description included in arm/Group description.
Primary Outcome Measure Information:
Title
Coping with Toddlers' Negative Emotion Scale
Description
A measure of parental behaviors in respond to toddlers' emotions. CTNES consists of 12 hypothetical situation where parents rate their likelihood of responding in six different ways on a scale from 1 (very unlikely) to 7 (very likely).
Time Frame
CTNES will be completed at baseline, post treatment (week 12) and follow-up month 9 after inclusion) to evaluate change from baseline to post-treatment and follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referred children aged 2-5 years
The child is enrolled in daycare
The child is displaying problems with emotional dysregulation
Exclusion Criteria:
Parent not sufficiently proficient in Norwegian Language to Complete assessment
Child Protective Services have ongoing assessment where the outcome may be that the child will be placed in care outside of the home of the biological parent(s) or other current caregiver
The child has already been diagnosed with an autism spectrum disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Aalberg, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUP Øvre Romerike
City
Jessheim
Country
Norway
Facility Name
BUP Grorud
City
Oslo
Country
Norway
Facility Name
Nic Waals Institutt
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Small Children, Big Emotions
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