Parenting InterventionNCT07795684
Digital Behavioral Parenting Programs With and Without Added Emotion Regulation Strategies to Manage Anger in Parenting
A study testing Online Behavioral Parent Training Program and Online Behavioral Parent Training + Emotion Regulation Program in people with Parenting Intervention and Anger, run by Karolinska Institutet at 5 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenting Intervention, Anger, Emotion Regulation Difficulties
- What is being tested?
- Online Behavioral Parent Training Program and Online Behavioral Parent Training + Emotion Regulation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesSweden
- Study dates
- 3 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Information indicating ongoing or recent violence toward the child perpetrated by parents or other adults in the home.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites
Danderyds kommun
Danderyd
Livia van Leuven, +46852482796, livia.van.leuven@ki.se
Gislaveds kommun
Gislaved
Livia van Leuven, +46852482796, livia.van.leuven@ki.se
Linköpings kommun
Linköping
Livia van Leuven, +46852482796, livia.van.leuven@ki.se
Österåkers kommun
Österåker
Livia van Leuven, +46852482796, livia.van.leuven@ki.se
Uppsala kommun
Uppsala
Livia van Leuven, +46852482796, livia.van.leuven@ki.se
About this study
Official title: Digital Parenting Programs to Manage Anger in Parenting: A Pilot Randomized Controlled Trial Comparing Behavioral Parent Training With and Without Added Emotion Regulation Strategies and a Waitlist Control
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:
- Are the study procedures and design feasible for a full-scale RCT?
- Are the SHIFT parenting programs feasible and acceptable?
- How do therapists and parents experience the SHIFT parenting programs?
- Is participation in one of the SHIFT parenting programs, relative to the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes?
- Is participation in the SHIFT parenting programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms?
Read more
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:
- 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.
Read the detailed description
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
- Are the study procedures and design feasible for a full-scale RCT, operationalized as (1) recruiting the target number of participants within a 6 month period, (2) completion of assessments, defined as the proportion of enrolled participants completing intervention outcomes at 8 weeks, and (3) that participants are referred through the tested recruitment pathways?
- Are the SHIFT parenting programs feasible and acceptable, operationalized as (1) compliance with the programs, defined as completing at least three of six online modules, (2) parent ratings of satisfaction, credibility and expectancy of the programs, and (3) that social service' family support workers (referred to as 'therapists') provide therapist support consistent with the intervention setup?
- How do therapists and parents experience that the digital parenting interventions have influenced parents, as well as therapists' work in supporting families, and how can the interventions be improved?
- Is participation in one of the SHIFT parenting programs, relative to participation in the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes, operationalized as (1) anger in parenthood, (2) parenting practices, (3) parent mental health and distress, and (4) children's mental health and behavior problems, and (5) parent ER, and how large are preliminary effect estimates?
- Is participation in the SHIFT-programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms, operationalized as (1) ER (reappraisal), (2) parenting practices, and (3) children's child disruptive behavior problems, and how large are preliminary effect estimates?
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.
- Conditions
- Parenting Intervention, Anger, Emotion Regulation Difficulties, Parenting Behaviour, Child Disruptive Behavior Disorders
- Being tested
- Online Behavioral Parent Training Program, Online Behavioral Parent Training + Emotion Regulation Program
- Keywords
- Parenting, Anger management, Parent training, Emotion regulation, Digital intervention, Parenting program, Pilot RCT, Prevention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Behavioral Parent Training ProgramBehavioural
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.
Online Behavioral Parent Training + Emotion Regulation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The SHIFT parenting program (behavioral parent training program) | Experimental | Participants assigned to this arm receive a digitally delivered program with parenting strategies. Receives: 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. Receives: Behavioral: Online Behavioral Parent Training + Emotion Regulation Program |
| Waitlist | Other | Participants wait 8 weeks + completion of post-assessment before receiving SHIFT or SHIFT+. Receives: Behavioral: Online Behavioral Parent Training Program; Behavioral: Online Behavioral Parent Training + Emotion Regulation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start3 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting InterventionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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+.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Forte: Swedish research council for health, working life and welfare
- Responsible party
- Principal investigator, Livia van Leuven, Karolinska Institutet
- Investigators
- Livia van Leuven, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795684
- Sponsor's protocol ID
- 2026-03609-01
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Parenting Programs to Manage Anger in Parenting: A Pilot Randomized Controlled Trial Comparing Behavioral Parent Training With and Without Added Emotion Regulation Strategies and a Waitlist Control
- ClinicalTrials.gov ID
- NCT07795684
- Acronym / sponsor ID
- 2026-03609-01
- Conditions
- Parenting Intervention, Anger, Emotion Regulation Difficulties, Parenting Behaviour, Child Disruptive Behavior Disorders
- Keywords
- Parenting, Anger management, Parent training, Emotion regulation, Digital intervention, Parenting program, Pilot RCT, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Forte: Swedish research council for health, working life and welfare
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are the study procedures and design feasible for a full-scale RCT?
- Are the SHIFT parenting programs feasible and acceptable?
- How do therapists and parents experience the SHIFT parenting programs?
- Is participation in one of the SHIFT parenting programs, relative to the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes?
- Is participation in the SHIFT parenting programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms?
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:
- 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.
Detailed description
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
- Are the study procedures and design feasible for a full-scale RCT, operationalized as (1) recruiting the target number of participants within a 6 month period, (2) completion of assessments, defined as the proportion of enrolled participants completing intervention outcomes at 8 weeks, and (3) that participants are referred through the tested recruitment pathways?
- Are the SHIFT parenting programs feasible and acceptable, operationalized as (1) compliance with the programs, defined as completing at least three of six online modules, (2) parent ratings of satisfaction, credibility and expectancy of the programs, and (3) that social service' family support workers (referred to as 'therapists') provide therapist support consistent with the intervention setup?
- How do therapists and parents experience that the digital parenting interventions have influenced parents, as well as therapists' work in supporting families, and how can the interventions be improved?
- Is participation in one of the SHIFT parenting programs, relative to participation in the other and relative to waitlist control, associated with improvements in parent-reported intervention outcomes, operationalized as (1) anger in parenthood, (2) parenting practices, (3) parent mental health and distress, and (4) children's mental health and behavior problems, and (5) parent ER, and how large are preliminary effect estimates?
- Is participation in the SHIFT-programs, relative to each other and waitlist control, associated with improvement in weekly measures of target mechanisms, operationalized as (1) ER (reappraisal), (2) parenting practices, and (3) children's child disruptive behavior problems, and how large are preliminary effect estimates?
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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+.
| Arm | Type | Receives |
|---|---|---|
| The SHIFT parenting program (behavioral parent training program) | Experimental | Behavioral: Online Behavioral Parent Training ProgramParticipants assigned to this arm receive a digitally delivered program with parenting strategies. |
| The SHIFT+ parenting program (behavioral parent training + emotion regulation strategies) | Experimental | Behavioral: Online Behavioral Parent Training + Emotion Regulation ProgramParticipants assigned to this arm receive a digitally delivered program with both parenting strategies and emotion regulation strategies from anger-management treatments. |
| Waitlist | Other | Behavioral: Online Behavioral Parent Training Program, Behavioral: Online Behavioral Parent Training + Emotion Regulation ProgramParticipants wait 8 weeks + completion of post-assessment before receiving SHIFT or SHIFT+. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Information indicating ongoing or recent violence toward the child perpetrated by parents or other adults in the home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Behavioral Parent Training ProgramA 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. | Behavioural | The SHIFT parenting program (behavioral parent training program), Waitlist |
| Online Behavioral Parent Training + Emotion Regulation ProgramA 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. | Behavioural | The SHIFT+ parenting program (behavioral parent training + emotion regulation strategies), Waitlist |
Primary outcome
Participant Recruitment: Number of participants recruited
Time frame: Baseline
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).
Intervention Completion: Completion of at least 3 of 6 modules
Time frame: From intervention start to intervention completion, approximately 6 weeks
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.
Change from baseline on the Multidimensional Assessment of Parenting Scale version 2
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
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.
10 secondary outcomes
Change from baseline on the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Parental Flooding Scale
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from screening assessment on the Parent Anger Scale - subscale Experienced Anger
Time frame: Screening assessment (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Strengths and Difficulties Questionnaire
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on Oppositional Defiant Disorder (ODD) scale
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Change from baseline on the Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: Baseline (before randomization), 8 weeks (primary endpoint), 6 months
Assessment completion: completion of 8-week post-assessment
Time frame: 8 weeks from baseline
Intervention credibility ratings
Time frame: 3 weeks from baseline
Parent-reported intervention satisfaction on the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Approximately 8 weeks from baseline
Therapist intervention satisfaction: Practitioner Acceptability Questionnaire
Time frame: Approximately 8 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Livia van Leuven, PhD principal investigator
Karolinska Institutet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Behavioral Parent Training Program and Online Behavioral Parent Training + Emotion Regulation Program in people with Parenting Intervention and Anger, run by Karolinska Institutet at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Livia van Leuven van Leuven, PhD (+46852482796, livia.van.leuven@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment: Number of participants recruited (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.