Emotional DisturbancesNCT04108949
Small Children, Big Emotions
A study testing Tuning in to Kids and Treatment as usual in people with Emotional Disturbances, run by University Hospital, Akershus at 3 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Emotional Disturbances
- What is being tested?
- Tuning in to Kids and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesNorway
- Study dates
- 15 Aug 2019to 13 Oct 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Referred children aged 2-5 years
- The child is enrolled in daycare
- The child is displaying problems with emotional dysregulation
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
BUP Øvre Romerike
Jessheim
BUP Grorud
Oslo
Nic Waals Institutt
Oslo
About this study
Official title: Tuning in to Kids: an Effectiveness Evaluation of Emotion Coaching to Parents and Daycare Teachers of At-risk Young Children
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.
- Conditions
- Emotional Disturbances
- Being tested
- Tuning in to Kids, Treatment as usual
- Medical subject headings
- Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuning in to KidsBehavioural
A psychosocial intervention focusing on emotion socialization and emotion coaching.
Treatment as usualBehavioural
See description included in arm/Group description.
| Study group | Role | What they receive |
|---|---|---|
| Tuning in to Kids | Experimental | Eight weekly two-hour sessions delivered in groups of up to six parents. Receives: Behavioral: Tuning in to Kids |
| Treatment as usual | Active comparator | 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Aug 2019
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisturbancesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with two arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of Melbourne, Extrastiftelsen
- Responsible party
- Principal investigator, Marianne Aalberg, University Hospital, Akershus
- Investigators
- Marianne Aalberg, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108949
- Sponsor's protocol ID
- 18/02391
- Status last verified
- Dec 2022
- First submitted
- 26 Sep 2019
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuning in to Kids: an Effectiveness Evaluation of Emotion Coaching to Parents and Daycare Teachers of At-risk Young Children
- ClinicalTrials.gov ID
- NCT04108949
- Acronym / sponsor ID
- 18/02391
- Conditions
- Emotional Disturbances
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo, University of Melbourne, Extrastiftelsen
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 30 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| Tuning in to Kids | Experimental | Behavioral: Tuning in to KidsEight weekly two-hour sessions delivered in groups of up to six parents. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment 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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Referred children aged 2-5 years
- The child is enrolled in daycare
- The child is displaying problems with emotional dysregulation
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Tuning in to KidsA psychosocial intervention focusing on emotion socialization and emotion coaching. | Behavioural | Tuning in to Kids |
| Treatment as usualSee description included in arm/Group description. | Behavioural | Treatment as usual |
Primary outcome
Coping with Toddlers' Negative Emotion Scale
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.
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).
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
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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.
Marianne Aalberg, PhD principal investigator
University Hospital, Akershus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuning in to Kids and Treatment as usual in people with Emotional Disturbances, run by University Hospital, Akershus 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Dec 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 was stopped early (reason given: 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). Results are not available in the source record.
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?
Coping with Toddlers' Negative Emotion Scale (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2022; AzTrials last refreshed its copy on 27 Oct 2026.