MedDataX Logo

Small Children, Big Emotions

NCT ID: NCT04108949

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2021-10-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Disturbances

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial with two arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are blinded to treatment condition and receive no information about which treatment the participant will receive or have received.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tuning in to Kids

Eight weekly two-hour sessions delivered in groups of up to six parents.

Group Type EXPERIMENTAL

Tuning in to Kids

Intervention Type BEHAVIORAL

A psychosocial intervention focusing on emotion socialization and emotion coaching.

Treatment as usual

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.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

See description included in arm/Group description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tuning in to Kids

A psychosocial intervention focusing on emotion socialization and emotion coaching.

Intervention Type BEHAVIORAL

Treatment as usual

See description included in arm/Group description.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

Extrastiftelsen

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marianne Aalberg

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marianne Aalberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BUP Øvre Romerike

Jessheim, , Norway

Site Status

BUP Grorud

Oslo, , Norway

Site Status

Nic Waals Institutt

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18/02391

Identifier Type: -

Identifier Source: org_study_id