NCT07795684

Brief Summary

This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of two digital parenting interventions for parents experiencing difficulties with anger in parenting. The interventions are internet-delivered adaptations of evidence-based parenting programs, collectively called the Supporting Healthier Interactions in Families by Online Tools (SHIFT) parenting programs. The main questions the study aims to answer are:

  • Be randomized to SHIFT, SHIFT+ or waitlist control.
  • Take part in one of the digital interventions and receive support in text messages and phone calls from a therapist at family support services in Swedish municipalities. Some participants will take part in the intervention after the waitlist period.
  • Respond to questionnaires and take part in interviews.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

5 active sites

Status
not yet 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 Progress7%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

August 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 3, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 24, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

ParentingAnger managementParent trainingEmotion regulationDigital interventionParenting programPilot RCTPrevention

Outcome Measures

Primary Outcomes (3)

  • Participant Recruitment: Number of participants recruited

    The number of eligible participants recruited within 6 months, or the recruitment time if the target sample size is reached before 6 months. For each participant, this is assessed at baseline (i.e., if the participant is included).

    Baseline

  • Intervention Completion: Completion of at least 3 of 6 modules

    The proportion of participants who complete at least three of the six online intervention modules. Module completion is assessed through the digital intervention platform from intervention start until intervention completion or dropout.

    From intervention start to intervention completion, approximately 6 weeks

  • Change from baseline on the Multidimensional Assessment of Parenting Scale version 2

    Parenting practices are assessed using 31 items from the Multidimensional Assessment of Parenting Scale Version 2 (MAPS v2), covering six subscales: Proactive Parenting (6 items), Supportiveness (3 items), Positive Reinforcement (4 items), Warmth (4 items), Hostility (7 items), and Lax Control (7 items). Items are rated on a 5-point Likert scale ranging from 1 (Never) to 5 (Always). The four positive parenting subscales are summed to form a Positive Parenting broadband score ranging from 17 to 85, with higher scores indicating more frequent use of positive parenting practices. Hostility and Lax Control are scored separately, with each subscale ranging from 7 to 35 and higher scores indicating more frequent use of the respective negative parenting practice. The Physical Control subscale of the MAPS v2 is not administered; therefore, a Negative Parenting broadband score is not calculated.

    Baseline (before randomization), 8 weeks (primary endpoint), 6 months

Secondary Outcomes (10)

  • Change from baseline on the Patient Health Questionnaire (PHQ-9)

    Baseline (before randomization), 8 weeks (primary endpoint), 6 months

  • Change from baseline on the Parental Flooding Scale

    Baseline (before randomization), 8 weeks (primary endpoint), 6 months

  • Change from screening assessment on the Parent Anger Scale - subscale Experienced Anger

    Screening assessment (before randomization), 8 weeks (primary endpoint), 6 months

  • Change from baseline on the Strengths and Difficulties Questionnaire

    Baseline (before randomization), 8 weeks (primary endpoint), 6 months

  • Change from baseline on Oppositional Defiant Disorder (ODD) scale

    Baseline (before randomization), 8 weeks (primary endpoint), 6 months

  • +5 more secondary outcomes

Other Outcomes (11)

  • Parents experiences of negative effects of the interventions

    Weekly during intervention and 8 weeks from baseline

  • Weekly change during intervention in parental emotion regulation - reappraisal

    Weekly during intervention period (weeks 1-6 from baseline)

  • Weekly change during intervention in parenting practices (4 item inspired by the MAPS v2)

    Weekly during intervention period (weeks 1-6 from baseline)

  • +8 more other outcomes

Study Arms (3)

The SHIFT parenting program (behavioral parent training program)

EXPERIMENTAL

Participants assigned to this arm receive a digitally delivered program with parenting strategies.

Behavioral: Online Behavioral Parent Training Program

The SHIFT+ parenting program (behavioral parent training + emotion regulation strategies)

EXPERIMENTAL

Participants assigned to this arm receive a digitally delivered program with both parenting strategies and emotion regulation strategies from anger-management treatments.

Behavioral: Online Behavioral Parent Training + Emotion Regulation Program

Waitlist

OTHER

Participants wait 8 weeks + completion of post-assessment before receiving SHIFT or SHIFT+.

Behavioral: Online Behavioral Parent Training ProgramBehavioral: Online Behavioral Parent Training + Emotion Regulation Program

Interventions

A 6-week digital parent training program incorporating core components from established behavioral parent training programs. Delivered via a secure digital platform with one module per week, text-based therapist support from family support workers, and two brief check-in telephone calls. Strategies include: strengthening parent-child relationship (e.g., child-directed play), understanding how parents' behavior triggers and reinforces child behavior, selective attention and praise for positive behavior, preparations and effective commands, and natural consequences.

The SHIFT parenting program (behavioral parent training program)Waitlist

A 6-week digital program that integrates the same parenting strategies as SHIFT with additional emotion regulation strategies from anger-management treatments. Matched to SHIFT in duration and therapist contact. Emotion regulation strategies include: early identification and interruption of anger escalation, emotional awareness and self-validation, cognitive reappraisal, effective communication, and managing vulnerability to anger.

The SHIFT+ parenting program (behavioral parent training + emotion regulation strategies)Waitlist

Eligibility Criteria

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

You may qualify if:

  • Parent of a child or adolescent aged 2-17 years.
  • Experiences recurring conflicts with the child and recurring anger, irritation, or frustration in parenting situations, and wants strategies to manage situations where conflicts and/or anger occur. Determined via sores above the mean on the Parent Anger Scale (PAS; 10-item Swedish version) based on previous Swedish social service population data, and confirmed in a telephone screening. Another parent in the same family can also participate in the study and program even if they do not experience difficulties with anger.
  • Residing in or near a participating municipality.
  • Can read Swedish and has access to a smartphone, tablet, or computer with internet.
  • Perceives themselves to be able to work relatively independently in a digital intervention and is committed to setting aside time for the intervention.

You may not qualify if:

  • Information indicating ongoing or recent violence toward the child perpetrated by parents or other adults in the home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Danderyds kommun

Danderyd, Sweden

Location

Gislaveds kommun

Gislaved, Sweden

Location

Linköpings kommun

Linköping, Sweden

Location

Österåkers kommun

Österåker, Sweden

Location

Uppsala kommun

Uppsala, Sweden

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Livia van Leuven, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia van Leuven van Leuven, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Parents are masked to the study hypotheses and to the specific differences between the two parenting programs. They are informed that the study compares two digital parenting interventions and are given general information about the content, but the specific differences are not described in detail. Family support workers are aware of the intervention allocation. This is classified as open label because full blinding of participants and providers is not feasible.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Three-arm parallel pilot RCT. Participants are randomized 1:1:1 to SHIFT (behavioral parent training program), SHIFT+ (behavioral parent training + emotion regulation program), or 8-week waitlist. Waitlisted participants are re-randomized 1:1 to SHIFT or SHIFT+.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 31, 2026

Study Start

September 3, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Due to participant confidentiality and university regulations, there is no plan to share individual participant data. This might be revised pending approval from the Swedish Ethical Review Authority. If so, data underlying the results in publications could be shared with other researchers for aggregated analyses, e.g., individual participant data meta-analyses.

Locations