An interventional study of Online Behavioral Parent Training Program and Online Behavioral Parent Training + Emotion Regulation Program in Parenting Intervention, Anger and Emotion Regulation Difficulties, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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:
Researchers will compare the two programs against each other and against a waitlist control. The first intervention (SHIFT) is a behavioral parent training (BPT) program with parenting strategies to manage child behavior problems. The second intervention (SHIFT+) includes the same BPT strategies with emotion regulation (ER) techniques from anger-management treatments.
Participants will:
BACKGROUND Hard-to-manage anger can impact parenting and increase the risk for interpersonal difficulties, including violence between partners and physical and emotional violence by parents towards children. Several central risk factors for harsh parenting are tied to the caregiver, including hard-to-manage child-directed anger and parenting skills, which are modifiable intervention targets.
Targeting anger in parenting through emotion regulation (ER) strategies that have proven effective for anger problems in adults more broadly represents an under-researched approach. Behavioral parent training (BPT) programs have the strongest research support for reducing harsh and abusive parenting, yet meta-analyses generally show only modest between-group effects. At the same time, cognitive-behavioral interventions incorporating ER strategies have demonstrated efficacy for reducing anger in adults in randomized controlled trials. Integrating such strategies into BPT may offer a promising avenue for enhancing intervention effects, particularly for parents who struggle with anger and emotional escalation.
Delivering interventions digitally can also provide a more efficient and accessible way to reach families, as many families never initiate parenting interventions or discontinue them prematurely due to barriers such as transportation, time constraints, stigma, or shame. Importantly, robust evidence indicates that internet-delivered parenting programs can achieve effects comparable to those of face-to-face interventions.
AIM The overall aim of this project is to evaluate the feasibility, acceptability, and preliminary effects on intervention outcomes and target mechanisms of two newly developed digital parenting interventions, when delivered to parents who experience difficulties with anger in parenthood, compared both to each other and to a waitlist control.
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 first intervention is a BPT program (henceforth referred to as SHIFT) that includes parenting strategies to manage child disruptive behavior problems. The parenting strategies are drawn from established BPT programs. The second intervention (henceforth referred to as SHIFT+) integrates the same parenting strategies with emotion regulation (ER) techniques drawn from anger-management treatments. Findings from this study will inform a future large-scale RCT to evaluate the comparative effectiveness of these interventions compared with each other and with a waitlist control.
RESEARCH QUESTIONS
METHODS Recruitment and intervention delivery take place in collaboration with family support services within social services in municipalities across Sweden. The study setting is family support services that parents can access on their own initiative, without requirements on a child welfare report being filed.
The trial will be advertised to parents via municipal webpages and information distributed via local arenas into contact with parents, such as child health care, primary care, schools, preschools, family centers, and local newspapers. Social services/therapists also inform parents during routine contacts.
Parents who are interested in participating will access a study website. On the website, they first read more information about the study. Thereafter, they click on a link to read the detailed study information and provide digital informed consent. In the consent form, the parent indicates whether one or two parents in the family will participate.
When parents have consented to participate, they complete a digital screening. Parents who indicate that they 1) find the digital format suitable, 2) understand Swedish, and 3) score above a cut-off on the Parent Anger Scale (PAS) will be contacted for a telephone screening by the research team. During the telephone screening, the researcher will ensure that the participant has understood the study information, provide opportunity to ask questions, and assess eligibility according to the study's inclusion and exclusion criteria. If two parents take part in the study, the second parent must also complete consent and the baseline assessment before randomization. The second parent do not have to score above the PAS cut-off. Participants who are excluded will be informed of this decision and, where appropriate, referred to other municipal services or local healthcare.
Eligible participants will, after the telephone screening, complete baseline assessments and be randomized to: (1) SHIFT, (2) SHIFT+, or (3) waitlist. These three arms allow both to evaluate effects versus no intervention, and if ER improves the effects of BPT, which will be the focus of the coming full-scale RCT. Parents and a therapist/local study coordinator at each social service unit are informed about the allocation. The therapist/local coordinator assigns a therapist within their team who support parents during the intervention, which is delivered via a secure digital platform.
The researchers collect data by sending parents digital assessments via the platform. Parents complete assessments at baseline (before randomization), weekly during interventions or waitlist period, 8 weeks from baseline (post-assessment), and 6 months from baseline. Parents on the waitlist must complete the post-assessment before starting the intervention. When parents have completed the intervention, therapists also report their satisfaction with the intervention and the support provided during its delivery. Interviews with parents and therapists are conducted after completion of the interventions, following semi-structured interview guides. These will be conducted over telephone, recorded, and transcribed verbatim. All data is collected via the same secure platform as the internet delivered programs are delivered via.
RANDOMIZATION Block randomization with randomly varying block sizes will be used to allocate participants in a 1:1:1 ratio to SHIFT, SHIFT+, or the waitlist condition. The allocation sequence will be generated using a computer-based random number generator with the upcoming allocation concealed.
Randomization will take place after eligibility has been confirmed and the participant has completed the baseline assessment. At that point, the next allocation in the concealed sequence will be retrieved through a secure computerized procedure. Participants allocated to the waitlist will be re-randomized in a 1:1 ratio to receive SHIFT or SHIFT+ following the waiting period and completion of the 8-week assessment. A separate computer-generated allocation sequence with randomly varying block sizes will be used for this second randomization.
ANALYSES Analyses for research question 1: Feasibility of study procedures and design The number of participants recruited, and the recruitment time, is presented descriptively. If we include 80-90 families within 6 months, the trial procedures are considered feasible for a full-scale RCT. The proportion of parents completing intervention outcomes at 8 weeks follow-up will be presented.
Analyses for research question 2: Acceptability and feasibility of the SHIFT programs The proportion of participants who complete at least three of six online modules will be calculated and compared descriptively between the two active programs or with chi2-tests or similar. Group differences in quantitative feasibility ratings (e.g., satisfaction and credibility) will be examined using independent samples t-test or, depending on the number of families with two parents responding, appropriate inferential tests accounting for dependence among observations (e.g., multilevel modelling).
Analyses for research question 3: Experiences of digital interventions Qualitative data from interviews will be transcribed verbatim and analyzed using thematic analysis, content analysis or computationally intensive theory construction to identify patterns in the data, such as themes or categories, that are relevant to the research questions. Illustrative quotes will be presented.
Analyses for research question 4 and 5: Preliminary effects on intervention outcomes and target mechanisms The analyses will follow the intention-to-treat principle, i.e., including all participants as randomized. Effects only for intervention completers will be examined exploratory as a secondary analysis. Preliminary effects of the interventions on parent-rated outcomes assessed at repeated time points will be examined using linear mixed-effects models/generalized linear mixed-effects models or similar appropriate statistical models. Where two parents from the same family participate, nesting will be modelled to account for dependency in the data. At the post-assessment, the two active intervention conditions will be compared both with each other and with the waitlist control condition. At the 6-month follow-up, we will compare the two active interventions and explore whether gains observed in the intervention arms are maintained. At 6 months, participants who are randomized to SHIFT or SHIFT+ after the waitlist period will be included in an analysis comparing the two active interventions. Appropriate effect sizes, such as Cohen's d or odds ratios depending on the type of outcome variable, will be calculated.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 90 is above the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
Participants assigned to this arm receive a digitally delivered program with parenting strategies.
Behavioral: Online Behavioral Parent Training Program
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
Participants wait 8 weeks + completion of post-assessment before receiving SHIFT or SHIFT+.
Behavioral: Online Behavioral Parent Training Program · Behavioral: Online Behavioral Parent Training + Emotion Regulation Program
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.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Patient Health Questionnaire (PHQ-9)
Parents' symptoms of depression measured using the Patient Health Questionnaire-9 (PHQ-9; 9 items). 4-point Likert scale (0-3), total score 0-27, higher scores = greater severity of depression.
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Parental Flooding Scale
Parental flooding assessed using the Parental Flooding Scale (PFS; 15 items). Measures the extent to which parents experience their children's negative affect during conflicts as unexpected, overwhelming, and distressing. 5-point Likert scale (1-5), total score 15-75, higher scores = greater difficulties.
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from screening assessment on the Parent Anger Scale - subscale Experienced Anger
Parent-reported anger in parenthood measured using the Experienced Anger subscale of the Parent Anger Scale (PAS; 10-item Swedish version). Captures experienced anger toward children including physiological arousal, brooding, and rumination. 7-point Likert scale (0-6), total score 0-60, higher scores = more frequent anger.
Time frame: Screening assessment (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Strengths and Difficulties Questionnaire
Child mental health assessed using the parent-rated 25-item Strengths and Difficulties Questionnaire (SDQ). Items rated on a scale of 0-2, total score 0-50, higher scores = greater difficulties.
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on Oppositional Defiant Disorder (ODD) scale
Child disruptive behavior problems assessed using the parent-rated 8-item Oppositional Defiant Disorder (ODD) subscale from a scale assessing Disruptive Behavior Disorder. Rated on a 4-point scale (0-3), total score 0-24, higher scores = more behavior problems.
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Difficulties in Emotion Regulation Scale (DERS-16)
Parent-reported emotion regulation assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16). 5-point Likert scale (scored 1-5), total score 16-80, higher scores = more difficulties.
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Assessment completion: completion of 8-week post-assessment
Enrolled parents completing intervention outcomes at the 8-week post-assessment.
Time frame: 8 weeks from baseline
Intervention credibility ratings
Four questions inspired by the Credibility/Expectancy Questionnaire assessing: (1) suitability for target group, (2) belief program will help, (3) willingness to recommend, (4) expected improvement. Each item scored 0-10, total score 0-40, higher = higher credibility.
Time frame: 3 weeks from baseline
Parent-reported intervention satisfaction on the Client Satisfaction Questionnaire (CSQ-8)
Intervention satisfaction (parent-reported), assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8). Each item scored 1-4, total score 8-32, higher = greater satisfaction.
Time frame: Approximately 8 weeks from baseline
Therapist intervention satisfaction: Practitioner Acceptability Questionnaire
To assess intervention satisfaction from the practitioner perspective, therapists complete the Practitioner Acceptability Questionnaire post-intervention. A 7-item instrument rated on a 4-point Likert-scale coded 1-4 (total score: 7-28), with higher score indicating greater satisfaction with the support that parents have taken part in.
Time frame: Approximately 8 weeks from baseline
Parents experiences of negative effects of the interventions
Potential negative effects will be assessed post-intervention by asking parents who report that the intervention made their problems worse (based on an item included in the Client Satisfaction Questionnaire \[CSQ\]) to what extent this negatively affected them or their family. This is assessed using a single item rated on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). In addition, each week during the intervention, parents respond to an open-ended question asking whether the program has caused discomfort, felt burdensome, or had any other negative impact on them or their family during the past week.
Time frame: Weekly during intervention and 8 weeks from baseline
Weekly change during intervention in parental emotion regulation - reappraisal
Emotion regulation strategies assessed weekly using the Reappraisal subscale (6 items) of the Revised Parental Emotion Regulation Inventory (R-PERI). 7-point scale (1-7), total score 6-42, higher = better emotion regulation.
Time frame: Weekly during intervention period (weeks 1-6 from baseline)
Weekly change during intervention in parenting practices (4 item inspired by the MAPS v2)
Weekly parenting practices assessed using 4 items inspired by the MAPS v2. Positive parenting: 2 items (reflecting Warmth and Positive Reinforcement), score 2-10, higher = more positive. Negative parenting: 2 items (reflecting Lax Control and Hostility), score 2-10, higher = more negative.
Time frame: Weekly during intervention period (weeks 1-6 from baseline)
Weekly change during intervention in child disruptive behavior
Weekly child disruptive behavior assessed using 2 items inspired by the ODD subscale. 4-point scale (0-3), higher = more severe disruptive behavior.
Time frame: Weekly during intervention period (weeks 1-6 from baseline)
Feasibility of recruitment pathways
Parents report how they were referred to the study when completing the digital screening, to evaluate the feasibility of tested recruitment pathways. They can choose from pre-specified answering options and provide explanation in free-text.
Time frame: At screening
Fidelity to therapist support procedures
The extent to which family support workers provide therapist support in accordance with the specified intervention procedures. Fidelity will be assessed based on the number and content of text messages sent to participants through the digital intervention platform, and therapists' post-intervention reports of the number of telephone calls conducted and whether therapist support was delivered according to the specified intervention procedures.
Time frame: Approximately 8 weeks from baseline
Parents: Background data
Parents complete questions on their and their child's background (e.g., age, occupation, education, country of birth) and if they have previously taken part in parenting programs.
Time frame: Baseline
Therapists: Background data
Therapists trained within the project give brief data on their professional experience.
Time frame: Baseline
Free text feedback by parents
Each week during the intervention, an open-ended question asks parents on feedback on the intervention content.
Time frame: Weekly during intervention period (weeks 1-6 from baseline)
Parents: Experiences of digital interventions (qualitative interviews)
Semi-structured interviews exploring how parents experience that the digital parenting interventions have influenced them and how the interventions can be improved.
Time frame: Approximately 10 weeks from baseline
Therapists: Experiences of digital interventions (qualitative interviews)
Semi-structured interviews exploring how therapists experience that the digital parenting interventions have influenced parents, their work in supporting families, and how the interventions can be improved.
Time frame: Approximately 10 weeks from baseline
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2027, 11 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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