Conduct Disorders in ChildrenNCT07201090
Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy
A study testing Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films in people with Conduct Disorders in Children and Disruptive Behavior, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The aim of this study is to evaluate the effects and feasibility of a shortened version of Parent-Child Interaction Therapy (PCIT), supplemented with video vignettes of parenting skills and 360-virtual reality (VR)-films for parents of children aged 2-7 years with disruptive behavior problems. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Conduct Disorders in Children, Disruptive Behavior, Oppositional Defiant Disorder
- What is being tested?
- Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Oct 2025to 31 Dec 2026
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged 2-7 years
- Elevated disruptive behavior (ECBI score >114)
- Parent speaks Swedish or English
Who cannot join
- Child or family requiring more urgent intervention
- Parent condition that prevents VR use (e.g., epilepsy, severe migraine, adverse VR experiences)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Karolinska Institutet
Solna
Pia Enebrink, PhD
Region Stockholm
Stockholm
About this study
Official title: Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy, Supplemented by Videos and Virtual Reality-films
The aim of this study is to evaluate the effects and feasibility of a shortened version of Parent-Child Interaction Therapy (PCIT), supplemented with video vignettes of parenting skills and 360-virtual reality (VR)-films for parents of children aged 2-7 years with disruptive behavior problems. The main questions the study aims to answer, using a Single-Case Experimental Design, are:
- How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?
- What are the preliminary effects of brief PCIT-VR?
- How do parents and clinicians experience brief PCIT-VR?
Families at child and adolescent psychiatry clinics will receive up to 10 PCIT sessions. Caregivers complete quantitative assessments before, during, after treatment, and at 6-months follow-up, and are asked to participate in interviews after PCIT. Feasibility and acceptability of brief PCIT VR is evaluated, as well as effectiveness outcomes, including changes in child disruptive behavior and parenting skills. Within-group analyses will examine trends in outcome measures over time.
Read the detailed description
BACKGROUND:
Persistent and clinically significant behavior problems are associated with long-term negative outcomes if left untreated. Early and effective interventions are critical for children's development and to reduce long-term societal costs.
Parent training programs are the most effective evidence-based interventions for children under 12 years with externalizing behavior problems. Parent-Child Interaction Therapy (PCIT) is one of the most rigorously evaluated programs for children aged 2-7 years. PCIT is distinctive in that it uses live coaching, where the therapist guides parents in real time as they interact with their child. Several meta-analyses demonstrate large effects of PCIT in reducing child disruptive behavior and improving parenting skills.
However, both the length of PCIT treatment and dropout rates remain challenges. The PCIT protocol often requires 15-25 sessions, and high attrition rates have been reported in routine care. Promisingly, research suggests that PCIT can still be effective when families end treatment early or when time-limited PCIT protocols are used. Further evaluations are needed to understand how effectiveness in briefer treatment formats can be maintained.
Using films and videos for parenting skills modelling, and virtual reality (VR) for practice may enhance skill learning and allow parents to continue practicing outside therapy sessions. VR can provide realistic training opportunities, enabling parents to observe and rehearse parenting skills. A study in the Netherlands has used VR in PCIT with promising results.
This study will implement and evaluate a time-limited (shortened) PCIT format combined with VR and film-based components (brief PCIT-VR). By limiting treatment to 10 sessions and supplementing with these pedagogical tools, the intervention aims to balance effectiveness with feasibility.
PURPOSE AND RESEARCH QUESTIONS:
This study will evaluate preliminary effects, aspects of feasibility, and experiences with brief PCIT-VR.
Research questions:
- How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?
- What are the preliminary effects of brief PCIT-VR?
- How do parents and clinicians experience brief PCIT-VR?
METHOD:
This study will use a Single-Case Experimental Design (SCED).
Participants will be families including parents of children aged 2-7 years who present with disruptive behavior problems according to >114 on the Eyberg Child Behavior Inventory (ECBI). Families will be recruited through child and adolescent psychiatry clinics in Sweden. Clinicians working at these clinics will provide initial information about the study orally and in writing. Parents who express interest will be directed to an online portal where they receive written information. Both legal guardians provide written informed consent before participation. Parents fill out the ECBI to inform whether they meet inclusion criteria. A person from the research group contacts the family to provide more information and inform about inclusion or exclusion. If families are included, they are provided with login to a platform where they respond to weekly measurements, baseline/post treatment measurements, and during the treatment phase have access to video vignettes illustrating parenting skills. Parents will also have access to brief virtual reality-films at the clinic together with the therapist during two PCIT-sessions.
The study consists of three main phases: baseline, treatment, and follow-up. During the baseline phase (before treatment starts during approximately three weeks) and during the treatment phase, parents complete weekly questionnaires. In the middle of the treatment, parents respond to a longer measurement (ECBI). Before and after treatment, a larger battery of questions are administered (pre-, post- treatment, and 6-month follow-up assessments).
Each week during PCIT, parents are given access to a new module in the online platform with video vignettes of parenting skills, supplementing the session. The treatment phase involves up to 10 PCIT sessions. Semi-structured qualitative interviews will be conducted with both parents and clinicians after treatment to explore experiences, feasibility, and acceptability.
SAMPLE SIZE CALCULATION:
We aim to include a target of 15 families (approximately 15-30 parents), in line with SCED-study standards and similar SCED studies conducted internationally.
ANALYSES:
Quantitative data will be analyzed using visual inspection of weekly SCED graphs and statistical methods such as percent change calculations, Reliable Change Index analyses, and repeated-measures analyses of variance (ANOVA). Benchmarking will be used to compare outcomes with those from longer PCIT trials reported in the literature. Qualitative interview data will be analyzed thematically to identify key themes regarding feasibility, acceptability, and barriers and facilitators to implementation.
- Being tested
- Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films
- Keywords
- Parent training, Parent-Child Interaction Therapy, Virtual reality
- Medical subject headings
- Problem Behavior, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-filmsBehavioural
Also called Brief PCIT-VR
10 sessions of PCIT delivered by trained psychologists, supplemented with videos and 360-degree VR-films
Sessions follow the standard PCIT structure, with an initial phase focused on child-directed interaction, followed by a second, modified phase, focused on parent-directed interaction.
To support skill learning, families are provided with digital materials including conventional video modules at home and 360-degree virtual reality (VR) films. The VR films are shown during two sessions at the clinic. Additional videos are available online through a platform for parents to view and practice between sessions. These tools allow parents to rehearse skills flexibly in their home environment and reinforce the in-session training.
| Study group | Role | What they receive |
|---|---|---|
| Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films | Experimental | 10 sessions of Parent-Child Interaction Therapy (PCIT), supplemented with brief role-modeling videos of parenting skills, provided through an online project platform, and virtual reality (360-degree VR)-films shown during treatment sessions. Receives: Behavioral: Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory (ECBI) - Intensity scale
Measures frequency of externalizing behaviors in children. The scale includes 36 items which are rated on a 7-point-scale (1 to 7). The total scale sum ranges from minimum 36 to a maximum sum of 252. Higher score indicates more disruptive behavior problems.
Measured: Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory - Problem scale
Measures externalizing behaviors in children. The scale includes 36 items which are rated yes/no (1-0), indicating whether the behavior is experienced as problematic. Minimum summary score is 0, maximum score is 36. Higher score indicates more disruptive behavior problems.
Measured: Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Change from baseline phase to treatment phase in weekly reported disruptive behavior
Three weekly questions on disruptive behavior rated on an 8 point scale from 0-7. Minimum summary score is 0, maximum score is 21. Higher score indicates more disruptive behaviors.
Measured: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Secondary outcomes (9)
Mean change from pre-treatment in parent-rated callous unemotional behaviors on the Inventory of Callous Unemotional traits (ICU) scale
The 12 item version of the Inventory of Callous Unemotional scale measures perceived callous or unemotional behaviors. The scale consists of 12 items rated on a 4-point Likert scale from 0 to 3. Total scores range from 0 to 36, with higher scores indicating higher levels.
Measured: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10)
Mean change from pre-treatment in parent-rated stress on the Perceived Stress Scale (PSS)
The 10 item Perceived Stress Scale measures perceived stress on a 5-point Likert scale scored 0-4 (minimum scale value is 0, maximum is 40). Higher scores indicate more stress.
Measured: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - frequency scale
A 21 item rating scale completed by parents, measuring parenting behaviors and strategies. Parents rate the frequency of parenting strategies/activities on a scale scored 1-5 (ranging between 21-105). Higher values represent using positive parenting strategies more frequently.
Measured: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - problem scale
A 21 item rating scale completed by parents, measuring parenting behaviors and strategies. Parents indicate whether they find performing the parenting strategy/activity problematic (yes/no; rated 1-0), with a summary score ranging between 0-21. Higher values reflect greater parenting challenges.
Measured: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Change from baseline phase to treatment phase in weekly reported warmth and relationship quality
Four weekly questions on warmth and relationship-enhancing behaviors (playing, doing nice things, positive attention and affection). Rated on a 7 point scale from 0-6. Minimum summary score is 0, maximum summary score is 24. Higher scores indicate higher levels of warmth and relationship-enhancing behaviors.
Measured: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Change from baseline phase to treatment phase in weekly reported parental anger
One weekly question of whether parents have felt upset with or angry at their children. Rated on a 7 point scale from 0-6. Higher score indicates more frequent experiences of anger.
Measured: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Change from baseline phase to treatment phase in weekly reported emotion regulation
If parents report being angry at least once across the past week, two follow-up questions inquire about how parents handled the situation. These items are rated on a 6 point scale scored 0-5. Summary score ranges between 0 and 10. Higher scores indicate more frequent instances of remaining calm.
Measured: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Change from baseline phase to treatment phase in weekly reported consistent parenting
One item assesses whether parents have been consistent with holding on to rules despite repeated requests from their children. Responses are rated on a 6 point scale (0-5), with higher scores indicating greater consistency.
Measured: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale
Parental emotion regulation will be measured with the Parent Emotion Regulation Scale. The 20 items are scored on a 5-point scale (1 to 5). A total summary score ranges between 20 and 100, where a higher score indicates better regulation of emotions.
Measured: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct Disorders in ChildrenStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Pia Enebrink, Karolinska Institutet
- Investigators
- Pia Enebrink, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201090
- Sponsor's protocol ID
- 2024-08744-01
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy, Supplemented by Videos and Virtual Reality-films
- ClinicalTrials.gov ID
- NCT07201090
- Acronym / sponsor ID
- 2024-08744-01
- Keywords
- Parent training, Parent-Child Interaction Therapy, Virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
The aim of this study is to evaluate the effects and feasibility of a shortened version of Parent-Child Interaction Therapy (PCIT), supplemented with video vignettes of parenting skills and 360-virtual reality (VR)-films for parents of children aged 2-7 years with disruptive behavior problems. The main questions the study aims to answer, using a Single-Case Experimental Design, are:
- How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?
- What are the preliminary effects of brief PCIT-VR?
- How do parents and clinicians experience brief PCIT-VR?
Families at child and adolescent psychiatry clinics will receive up to 10 PCIT sessions. Caregivers complete quantitative assessments before, during, after treatment, and at 6-months follow-up, and are asked to participate in interviews after PCIT. Feasibility and acceptability of brief PCIT VR is evaluated, as well as effectiveness outcomes, including changes in child disruptive behavior and parenting skills. Within-group analyses will examine trends in outcome measures over time.
Detailed description
BACKGROUND:
Persistent and clinically significant behavior problems are associated with long-term negative outcomes if left untreated. Early and effective interventions are critical for children's development and to reduce long-term societal costs.
Parent training programs are the most effective evidence-based interventions for children under 12 years with externalizing behavior problems. Parent-Child Interaction Therapy (PCIT) is one of the most rigorously evaluated programs for children aged 2-7 years. PCIT is distinctive in that it uses live coaching, where the therapist guides parents in real time as they interact with their child. Several meta-analyses demonstrate large effects of PCIT in reducing child disruptive behavior and improving parenting skills.
However, both the length of PCIT treatment and dropout rates remain challenges. The PCIT protocol often requires 15-25 sessions, and high attrition rates have been reported in routine care. Promisingly, research suggests that PCIT can still be effective when families end treatment early or when time-limited PCIT protocols are used. Further evaluations are needed to understand how effectiveness in briefer treatment formats can be maintained.
Using films and videos for parenting skills modelling, and virtual reality (VR) for practice may enhance skill learning and allow parents to continue practicing outside therapy sessions. VR can provide realistic training opportunities, enabling parents to observe and rehearse parenting skills. A study in the Netherlands has used VR in PCIT with promising results.
This study will implement and evaluate a time-limited (shortened) PCIT format combined with VR and film-based components (brief PCIT-VR). By limiting treatment to 10 sessions and supplementing with these pedagogical tools, the intervention aims to balance effectiveness with feasibility.
PURPOSE AND RESEARCH QUESTIONS:
This study will evaluate preliminary effects, aspects of feasibility, and experiences with brief PCIT-VR.
Research questions:
- How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?
- What are the preliminary effects of brief PCIT-VR?
- How do parents and clinicians experience brief PCIT-VR?
METHOD:
This study will use a Single-Case Experimental Design (SCED).
Participants will be families including parents of children aged 2-7 years who present with disruptive behavior problems according to >114 on the Eyberg Child Behavior Inventory (ECBI). Families will be recruited through child and adolescent psychiatry clinics in Sweden. Clinicians working at these clinics will provide initial information about the study orally and in writing. Parents who express interest will be directed to an online portal where they receive written information. Both legal guardians provide written informed consent before participation. Parents fill out the ECBI to inform whether they meet inclusion criteria. A person from the research group contacts the family to provide more information and inform about inclusion or exclusion. If families are included, they are provided with login to a platform where they respond to weekly measurements, baseline/post treatment measurements, and during the treatment phase have access to video vignettes illustrating parenting skills. Parents will also have access to brief virtual reality-films at the clinic together with the therapist during two PCIT-sessions.
The study consists of three main phases: baseline, treatment, and follow-up. During the baseline phase (before treatment starts during approximately three weeks) and during the treatment phase, parents complete weekly questionnaires. In the middle of the treatment, parents respond to a longer measurement (ECBI). Before and after treatment, a larger battery of questions are administered (pre-, post- treatment, and 6-month follow-up assessments).
Each week during PCIT, parents are given access to a new module in the online platform with video vignettes of parenting skills, supplementing the session. The treatment phase involves up to 10 PCIT sessions. Semi-structured qualitative interviews will be conducted with both parents and clinicians after treatment to explore experiences, feasibility, and acceptability.
SAMPLE SIZE CALCULATION:
We aim to include a target of 15 families (approximately 15-30 parents), in line with SCED-study standards and similar SCED studies conducted internationally.
ANALYSES:
Quantitative data will be analyzed using visual inspection of weekly SCED graphs and statistical methods such as percent change calculations, Reliable Change Index analyses, and repeated-measures analyses of variance (ANOVA). Benchmarking will be used to compare outcomes with those from longer PCIT trials reported in the literature. Qualitative interview data will be analyzed thematically to identify key themes regarding feasibility, acceptability, and barriers and facilitators to implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films | Experimental | Behavioral: Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films10 sessions of Parent-Child Interaction Therapy (PCIT), supplemented with brief role-modeling videos of parenting skills, provided through an online project platform, and virtual reality (360-degree VR)-films shown during treatment sessions. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child aged 2-7 years
- Elevated disruptive behavior (ECBI score >114)
- Parent speaks Swedish or English
Key exclusion criteria (2 listed)
- Child or family requiring more urgent intervention
- Parent condition that prevents VR use (e.g., epilepsy, severe migraine, adverse VR experiences)
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 |
|---|---|---|
| Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-filmsAlso: Brief PCIT-VR10 sessions of PCIT delivered by trained psychologists, supplemented with videos and 360-degree VR-films Sessions follow the standard PCIT structure, with an initial phase focused on child-directed interaction, followed by a second, modified phase, focused on parent-directed interaction. To support skill learning, families are provided with digital materials including conventional video modules at home and 360-degree virtual reality (VR) films. The VR films are shown during two sessions at the clinic. Additional videos are available online through a platform for parents to view and practice between sessions. These tools allow parents to rehearse skills flexibly in their home environment and reinforce the in-session training. | Behavioural | Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films |
Primary outcome
Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory (ECBI) - Intensity scale
Time frame: Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Measures frequency of externalizing behaviors in children. The scale includes 36 items which are rated on a 7-point-scale (1 to 7). The total scale sum ranges from minimum 36 to a maximum sum of 252. Higher score indicates more disruptive behavior problems.
Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory - Problem scale
Time frame: Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Measures externalizing behaviors in children. The scale includes 36 items which are rated yes/no (1-0), indicating whether the behavior is experienced as problematic. Minimum summary score is 0, maximum score is 36. Higher score indicates more disruptive behavior problems.
Change from baseline phase to treatment phase in weekly reported disruptive behavior
Time frame: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Three weekly questions on disruptive behavior rated on an 8 point scale from 0-7. Minimum summary score is 0, maximum score is 21. Higher score indicates more disruptive behaviors.
9 secondary outcomes
Mean change from pre-treatment in parent-rated callous unemotional behaviors on the Inventory of Callous Unemotional traits (ICU) scale
Time frame: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10)
Mean change from pre-treatment in parent-rated stress on the Perceived Stress Scale (PSS)
Time frame: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - frequency scale
Time frame: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - problem scale
Time frame: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
Change from baseline phase to treatment phase in weekly reported warmth and relationship quality
Time frame: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Change from baseline phase to treatment phase in weekly reported parental anger
Time frame: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Change from baseline phase to treatment phase in weekly reported emotion regulation
Time frame: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Change from baseline phase to treatment phase in weekly reported consistent parenting
Time frame: Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).
Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale
Time frame: Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Pia Enebrink, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films in people with Conduct Disorders in Children and Disruptive Behavior, run by Karolinska Institutet at 2 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 3 inclusion and 2 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Pia Enebrink, PhD (+46852487738, pia.enebrink@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory (ECBI) - Intensity scale (time frame: Screening (at inclusion), pre-treatment (treatment phase week 0), mid treatment (treatment phase week 6), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment)). 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 1 Oct 2025.