NCT07350083

Brief Summary

Early parent-child interactions, namely how parents respond to their children's emotions (i.e., emotion socialization parenting practices \[ESPP\]), may play a critical role in how children develop emotion regulation abilities. When parents rely on unsupportive ESPP, this can result in regulatory problems, which are a transdiagnostic symptom of MH problems, being a major cause of its etiology. Emotion-focused parenting programs, such as Tuning in to Kids® (TIK), promote parents' emotion coaching skills, enabling children to understand and regulate their emotions in more effective ways, while also supporting parents in managing their own emotions. This study aims to examine the feasibility, acceptability, implementation fidelity and efficacy of the TIK program among parents of preschool-aged children in Portugal. TIK is a 6-week group, face-to-face program grounded in the principles of emotion coaching, among other theoretical backgrounds such as Mindfulness and Emotion Regulation Theories. This trial is a parallel two-arm randomized clinical trial. Participants will be parents/legal guardians (\> 18 years old) with at least one child between 3 and 6 years old and with proficiency in portuguese. At least 152 parents/legal guardians will be recruited with the support of several community partners. Interested parents will be contacted by telephone to confirm their eligibility. Participants will be informed about their eligibility during the intake interview, followed by a full explanation of the clinical trial procedures. Eligible participants will be randomly assigned to either the intervention group (TIK) or a waitlist control group, with the latter receiving the intervention after the follow-up assessment. The intervention consists of six weekly in-person group sessions plus one follow-up session, each lasting approximately 2 hours. Participants in both groups will complete questionnaires at three time points - baseline, post-intervention, and 2-month follow-up - covering different dimensions of children (e.g., children's emotional and developmental difficulties) and parental (e.g., parenting stress) psychological functioning, and parenting (e.g., ESPP).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress24%
Dec 2025Sep 2027

Study Start

First participant enrolled

December 2, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

December 23, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

Tuning in to Kids®parental emotion socializationrandomized controlled trialpreschoolchildren emotional and behavioral difficulties

Outcome Measures

Primary Outcomes (4)

  • Changes from baseline in parents' beliefs about children's emotions

    Measured with the Parents' Beliefs About Children's Emotions Questionnaire (PBACE). The PBACE is a 33-item self-report questionnaire, with items rated on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The present study will use the following subscales: Value of Anger, Manipulation, Control, and Autonomy. Subscale scores will be calculated by averaging item responses, with higher scores indicating stronger endorsement of the corresponding belief in that category.

    Baseline, immediately post-intervention, and 2 months follow-up

  • Changes from baseline in parents' reactions to children's emotions

    Measured with the Coping with Children's Negative Emotions Scale (CCNES). The CCNES is a parent-report measure assessing how parents respond to children's negative emotions across 12 hypothetical scenarios, with responses rated on a 7-point Likert scale from 1 (very unlikely) to 7 (very likely). The CCNES comprises seven subscales: Emotion-Focused, Problem-Focused, Expressive Encouragement, Minimizing, Punitive, Distress, and Ignoring reactions. Items from the first three subscales are summed to create a composite measure of emotion coaching, whereas items from the remaining four subscales are summed to assess emotion dismissing responses. For each scale, total scores are calculated by averaging item responses, with higher scores indicating greater endorsement of the corresponding practice.

    Baseline, immediately post-intervention, and 2 months follow-up

  • Changes from baseline in parents' emotion regulation (parenting-specific)

    Measured with the Interpersonal Mindfulness in Parenting Scale (IM-P). The IM-P is a 29-item self-report instrument rated on a 5-point Likert scale, from 1 (never true) to 5 (always true). The Self-Regulation in Parenting will be assessed as primary outcome. Subscale scores will be calculated by summing item responses. Higher scores on the Self-Regulation in Parenting subscale indicate greater ability to regulate emotions and behaviors within the parenting context.

    Baseline, immediately post-intervention, and 2 months follow-up

  • Changes from baseline in parents' emotional regulation (general)

    Measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). The DERS-SF is a self-report measure, including 18 items, rated on a 5-point Likert scale, ranging from 1 (almost never) to 5 (almost always). A total score is obtained by averaging all items, with higher scores indicating greater difficulties. In line with the recommendations of the Portuguese authors, items 1, 4 and 6 will be excluded from the analyses.

    Baseline, immediately post-intervention, and 2 month follow-up

Secondary Outcomes (5)

  • Changes from baseline in children's behavioral and emotional difficulties

    Baseline, immediately post-intervention, and 2 month follow-up

  • Changes from baseline in children' emotional regulation

    Baseline, immediately post-intervention, and 2 month follow-up

  • Changes from baseline in parenting stress

    Baseline, immediately post-intervention, and 2 month follow-up

  • Changes from baseline in depressive symptoms

    Baseline, immediately post-intervention, and 2 month follow-up

  • Changes from baseline in parenting self-efficacy

    Baseline, immediately post-intervention, and 2 month follow-up

Other Outcomes (3)

  • Acceptability of the intervention

    Immediately post-intervention

  • Feasibility of the intervention

    Immediately post-intervention

  • Implementation fidelity of the intervention

    During the intervention (at the end of each session).

Study Arms (2)

Tuning in to Kids® intervention

EXPERIMENTAL

Participants will attend a 6-week, in-person group program structured around emotion coaching principles (Tuning in to Kids®).

Behavioral: Tuning in to Kids®

Waiting list group

OTHER

Participants will be offered and receive TIK after the conclusion of the final follow-up assessment.

Behavioral: Tuning in to Kids®

Interventions

Tuning in to Kids® (TIK) is a manualized program delivered by trained facilitators (6 weekly - 2h - group sessions) and aimed to promote parents' emotion socialization practices that are supportive of the child's expression of emotion (emotion coaching; e.g., comforting, teaching constructive means of coping), while reducing unsupportive ESPP (emotion dismissing; e.g., punishing or minimizing). An additional booster session may be held after two months of program's conclusion. TIK includes strategies informed by emotion coaching principles, including psychoeducation, roleplays, video materials, mindfulness-based exercises, and group discussions. By addressing a core mechanism leading to different emotional and behavioral childhood disorders (i.e. difficulties in emotion regulation), TIK is susceptible to promoting children's long-term full potential and parental mental health outcomes.

Tuning in to Kids® interventionWaiting list group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents/legal guardians:
  • with at least one child aged between 3 and 6 years old (inclusive) who lives with the parent/legal guardian,
  • with at least 18 years old,
  • who can read, understand, and speak Portuguese
  • who live in the Lisbon Metropolitan Area or Lisbon District. When applicable, both parents will be allowed to participate.

You may not qualify if:

  • parents' poor Portuguese language skills
  • parents' being currently enrolled in another structured parenting program
  • if the target child is already attending elementary school at the time of recruitment
  • if the target child has a diagnosis of a severe Communication and/or Developmental Disorder, or
  • if the target child is under a child protection measure that implies that the child does not live with their parents (e.g., if the child is in foster care).
  • Only participants that give informed consent to participate in the study will be included and randomized to one of the study conditions (TIK vs. waiting list group).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology and Life Sciences, Lusófona University

Lisbon, 1749-024, Portugal

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 20, 2026

Study Start

December 2, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Collective results from this trial will be shared to scientific and non-scientific communities after its conclusion.

Locations