NCT04851704

Brief Summary

The current pilot project will a) adapt an evidence-based psychosocial intervention program and conduct a randomized controlled trial with a group of Norwegian parents of preschool children, b) evaluate the intervention'simpact on child mental health and c) investigate the cognitive and physiological underpinnings of this effect.This pilot study will recruit 40 Norwegian parents of preschool children prior to the transition to starting school. Baseline measures will include parent emotion coaching and parent functioning, child emotion regulation, social and behavioral functioning, child behavioral and physiological indices of cognitive capacity and attention functioning, and school adjustment. Following completion of baseline assessment, parents will be randomized into Intervention or Wait-list conditions. Intervention parents will attend a 6-session group parenting program where they will learn to emotion coach their children and regulate their own emotions. Post-program, Intervention parents will complete program evaluation to determine program feasibility and acceptability. At 6-month follow-up baseline assessments will be repeated for Intervention and Wait-list participants with primary school teachers reporting on children's adjustment to school. Wait-list parents will then be offered the N-TIK program.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jan 2016Dec 2026

Study Start

First participant enrolled

January 1, 2016

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

11 years

First QC Date

April 14, 2021

Last Update Submit

November 2, 2022

Conditions

Keywords

Tuning in to KidsParent InterventionsChild self-regulation

Outcome Measures

Primary Outcomes (7)

  • Parent Emotional Style Questionnaire (PESQ)

    Parent Emotion Socialization Questionnaire (PESQ) is a scale with items that are scored from 1 to 5, where 5 indicates high levels of specific parenting beliefs (i.e. emotion coaching and emotion dismissive beliefs).

    Six months: Change in PESQ from baseline to follow up 6 months after baseline measured by questionnaire reports.

  • Coping with children negative emotions scale (CCNES)

    Coping with children negative emotions scale (CCNES) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of specific parenting behavior (i.e. supportive and nonsupportive parenting behavior).

    Six months: Change in CCNES from baseline to 6 months follow-up measured by questionnaire reports.

  • Eysenck's child behavior questionnaire (ECBI)

    Eysenck's child behavior questionnaire (ECBI) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of behavior problems.

    Six months: Change in ECBI from baseline to 6 months follow-up measured by questionnaire reports.

  • Preschool anxiety scale - revised (PAS-R)

    Preschool anxiety scale - revised (PAS-R) is a scale with items that are scored from 1 to 5, where higher score indicates higher levels of anxiety.

    Six months: Change in PAS-R from baseline to 6 months follow-up measured by questionnaire reports.

  • Emotional Go/Nogo task (EGNG)

    EGNG is a direct assessment of child behavior - an adaptation from the Go/NoGo task - a well-established cognitive paradigm. When modified with emotional stimuli in the form of faces with different positive and negative emotional expressions serving as either target or non-target, the task allows for behavioural assessment of emotion discrimination, emotion regulation and cognitive control, which are related, yet separable processes (Tottenham et al. 2011).

    Six months: Change in EGNG from baseline to 6 months follow-up measured by lab assessment.

  • AX Continuous Performance Task (AX-CPT)

    AX-CPT is a direct assessment of child behavior - The AX-CPT task (a version of the classic Continuous Performance Test, Rosvold et al. (1956)) is among the tasks most frequently used to study adaptive cognitive control by cognitive and clinical neuroscientists (Cohen and Servan-Schreiber,1992; Servan-Schreiber et al.,1996). In particular, the task makes it possible to distinguish between proactive or reactive control modes (Braver (2012); Braver et al. 2007).

    Six months: Change in AX-CPT from baseline to 6 months follow-up measured by lab assessment.

  • Test of Emotion Comprehension (TEC)

    The TEC is a direct assessment measure used to capture child emotion understanding (Kårstad et al., 2015; Pons \& Harris, 2000). The TEC measures nine components of emotion understanding: 1) emotion recognition, 2) external cause, 3) desire, 4) belief, 5) reminder, 6) regulation, 7) hidden, 8) mixed, and 9) morally based emotions.

    Six months: Change in TEC from baseline to 6 months follow-up measured by lab assessment.

Study Arms (2)

Intervention: Tuning in to Kids parenting program

EXPERIMENTAL

Intervention groups receive the Tuning in to Kids parenting program

Behavioral: Tuning in to Kids

Control: Business as usual

NO INTERVENTION

Control groups have "business as usual", and then get offered the intervention program after 6 months follow-up assessment.

Interventions

A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.

Intervention: Tuning in to Kids parenting program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A preschool child aged 5-6 years old
  • Parent of a preschool child aged 5-6 years old

You may not qualify if:

  • Parents under the age of 18
  • Parents not able to read and write in Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0358, Norway

Location

Study Officials

  • Evalill Bølstad, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention-control trial, where both intervention and control group participants are assessed at baseline, and then the intervention groups get the intervention, and all group participants are assessed at follow up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 20, 2021

Study Start

January 1, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations