Small Children, Big Emotions

NCT04108949 | Terminated

• 1 other identifier: 18/02391
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Emotional Disturbances

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

Study Arms (2)

Tuning in to Kids

EXPERIMENTAL

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

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.

Behavioral: Treatment as usual

Interventions

Tuning in to Kids BEHAVIORAL

A psychosocial intervention focusing on emotion socialization and emotion coaching.

Tuning in to Kids

Treatment as usual BEHAVIORAL

See description included in arm/Group description.

Treatment as usual

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Referred children aged 2-5 years
• The child is enrolled in daycare
• The child is displaying problems with emotional dysregulation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• University of Melbourne: collaborator
• Extrastiftelsen: collaborator

Study Sites (3)

BUP Øvre Romerike

Jessheim, Norway

Location

BUP Grorud

Oslo, Norway

Location

Nic Waals Institutt

Oslo, Norway

Location

MeSH Terms

Conditions

Affective Symptoms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Marianne Aalberg, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to treatment condition and receive no information about which treatment the participant will receive or have received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: A randomized controlled trial with two arms.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: August 15, 2019
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

NO (3)