Skip to main content
Clinical Trials/NCT04851704
NCT04851704Active, not recruitingNot Applicable

Child Self-regulation: Impact and Neurocognitive Underpinnings of a Psychosocial Intervention

University of Oslo2 sites in 1 country79 target enrollmentStarted: January 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
79
Locations
2
Primary Endpoint
Emotional Go/Nogo task (EGNG)

Study Overview

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.

Detailed Description

Promoting the emotional functioning of preschool children prior to the transition to school has important implications for their adjustment and mental health. Parents can assist children to understand and regulate their emotions thereby better equipping the child as they face this often highly stressful and anxiety provoking period. In addition, we need more knowledge on how processes on both behavioral and physiological levels can contribute to explain the mechanisms underlying changes in child self-regulation influenced by parents and the home environment.

Thus, a 2 x 2 intervention design pilot study of the Norwegian version of Tuning in to Kids (N-TIK) comparing intervention and wait-list participants will examine:

i) Does N-TIK lead to better parent-reported parent emotion coaching? ii) Does N-TIK lead to better parent-reported child emotional competencies, mental health and adjustment? iii) Does N-TIK lead to improved child attentional and executive functions as measured by behavioral performance and changes in neural and pupillometric responses in experimental tasks? The intervention aims to improve the responsiveness of parents to emotions, both in themselves and their children. Theoretically, this is anticipated to lead to children developing greater awareness and knowledge of their own emotional experience, to reduced levels of emotionality, and to greater internal self-awareness of their emotions (cognitive awareness about emotional experience). These comprise some of the core emotional competencies relevant for enhancing the transition to school. In turn these competencies are anticipated to be related to greater emotional, cognitive and physiological regulation as assessed by experimental paradigms and physiological measures. For children at risk (due to limited emotional, cognitive, physiological and behavioural regulation), an intervention that assists their parents to learn specific skills that enhance their emotion-related parenting, these risks are likely to be mitigated.

This study will be highly innovative on several counts. It will: gather preliminary evidence using a 2 x 2 intervention design for the effectiveness of an emotion-focused parenting program using a Norwegian sample; use cutting-edge behavioral and physiological measures to see whether participation in N-TIK leads to improved child attentional and executive functions - critical skills that assist with learning and self-regulation; integrate important disciplines within psychology by combining an intervention including preventive actions with emotional, neurocognitive and physiological approaches within adevelopmental psychological framework.

Statistical Analyses Time 1 data will be examined to determine relationships between key constructs. ANCOVA will be used to examine changes over time and to compare Intervention and Wait-list participants on all outcomes.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Emotional Go/Nogo task (EGNG)

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

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).

Test of Emotion Comprehension (TEC)

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

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.

AX Continuous Performance Task (AX-CPT)

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

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).

Parent Emotional Style Questionnaire (PESQ)

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

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).

Coping with children negative emotions scale (CCNES)

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

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).

Eysenck's child behavior questionnaire (ECBI)

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

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.

Preschool anxiety scale - revised (PAS-R)

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Evalill Bølstad, PhD

Associate Professor

University of Oslo

Study Sites (2)

Loading locations...

Similar Trials

Child Self-regulation: A Pilot Study on... | Clinical Trial