Disruptive BehavioriPCIT pilotNCT06828302
Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors
A study testing Internet-delivered Parent-Child Interaction Therapy in people with Disruptive Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this feasibility study is to evaluate feasibility of Internet-delivered Parent-Child Interaction Therapy for parents of children 2-7 years with disruptive behaviors. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Disruptive Behavior
- What is being tested?
- Internet-delivered Parent-Child Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 10 Mar 2025to 22 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Children aged 2-7 years
- Disruptive behaviors as assessed with Eyberg Child Behavior Inventory (ECBI) ≥126 for boys and ≥121 for girls (which corresponds to the 90th percentile according to Swedish norms)
- Language ability equivalent to at least an average 2-year-old, defined as a vocabulary of ≥ 25 word and ability to understand simple instructions, assessed with a language screening form
Who cannot join
- Severe autism spectrum condition (autism level 2 or 3 or equivalent functioning)
- parents who are not proficient enough in the Swedish language to complete questionnaries and receive therapy without an interpreter
- Presence of severe parental psychiatric disorders such as psychosis or suicidal ideations
- Ongoing severe psychosocial distress such as custody dispute.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this feasibility study is to evaluate feasibility of Internet-delivered Parent-Child Interaction Therapy for parents of children 2-7 years with disruptive behaviors. The main questions it aims to answer are:
- Could a brief online version of PCIT (iPCIT) be feasible for reducing disruptive behaviors and internalizing problems in young children, and for improving the quality of parent-child interaction?
- How is iPCIT experienced by participating parents?
Participants will receive a 10-week online intervention of Parent-Child Interaction Therapy and answer questionnaires online weekly.
Read the detailed description
Severe early behavioral problems increase the risk of impaired functioning in childhood and later life. Parent-Child Interaction Therapy (PCIT) is particularly effective for young children (age 2-7) with disruptive behaviors but is unimplemented in Sweden. Barriers to PCIT implementation include time constraints for parents and therapist challenges. An abbreviated internet-delivered version, iPCIT, may address these barriers. The objective of the study is to evaluate feasibility and acceptability of iPCIT.
Research questions
This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 10 weekly modules delivered over the Internet with guided support from an experienced CBT-trained psychologist and 5 biweekly videosessions where parents practice parental skills in a play situation with their child while receiving feedback and support from their therapist.
Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Twenty participants (parents of children aged 2-7 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed), any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze long term clinical effects.
- Conditions
- Disruptive Behavior
- Being tested
- Internet-delivered Parent-Child Interaction Therapy
- Keywords
- Internet-CBT, Parent, Children, Parent-Child Interaction Therapy
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Parent-Child Interaction TherapyBehavioural
Also called Internet-CBT, Internet-delivered cognitive behavior therapy
Parent management training delivered online where Internet-modules are combined with video sessions for live coaching.
| Study group | Role | What they receive |
|---|---|---|
| iPCIT | Other | Online parent management training (PMT) to teach parental skills (10 weekly online modules) combined with videosession for coaching of parental skills (5 biweekly sessions) Receives: Behavioral: Internet-delivered Parent-Child Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory
Caregiver report form measuring disruptive behaviors in children. 36 items with answers ranging from 1 (never) to 7 (always). Minimum value: 36. Maximum value: 252. A higher score means worse outcome.
Measured: From pretreatment to 18 weeks
Secondary outcomes (8)
Weekly assessment of Child Behavior Forms
Short caregiver report form measuring disruptive behaviors in children. Two scales with 9 items each with answers ranging from 1 (never) to 7 (always). Minimum value: 9. Maximum value: 63. A higher score means worse outcome.
Measured: From pretreatment to 18 weeks
Child Behavior Checklist
Caregiver report form identifying problem behavior in children. 99 items with answers ranging from 0 (do not agree) to 2 (strongly agree). Minimum value: 0. Maximum value: 198. A higher score means worse outcome.
Measured: From pretreatment to 10 weeks
Dyadic Parent-Child Interaction Coding System
Observation System measuring parental behavior and child behavior. The frequency of specified behaviors are measured during a five minute long standardized play situation.
Measured: From pretreatment to 10 weeks
Brunnsviken Brief Quality of Life Scale
Questionnaire about quality of life. 12 items with answers ranging from 1 (strongly disagree) to 4 (strongly agree). Minimum value: 0. Maximum value: 96. A higher score means better outcome.
Measured: From pretreatment to 18 weeks
Perceived Stress Scale
Questionnaire measuring overall stress. A 7-item version of the scale will be used with answers ranging from 0 (never) to 4 (very often). Minimum value: 0. Maximum value: 28. A higher score means worse outcome.
Measured: From pretreatment to 18 weeks
Parental Stress Scale
Questionnaire measuring stress induced by parenthood. 18 items with answers from 1 ("strongly disagree") to 5 ("strongly agree"). Minimum value: 18. Maximum value: 90. A higher score means worse outcome.
Measured: From pretreatment to 18 weeks
Difficulties in Emotion Regulation Scale
Questionnaire measuring emotion regulation ability. 16 items with answers ranging from 1 (almost never) to 5 (almost always). Minimum value: 16. Maximum value: 80. A higher score means worse outcome.
Measured: From pretreatment to 18 weeks
Parenting Young Children Scale
Questionnaire measuring parental strategies. 6 items with answers ranging from 1 (never) to 7 (many times a day). Minimum value: 6. Maximum value: 42. A higher score means better outcome.
Measured: From pretreatment to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start10 Mar 2025
- Primary completion5 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive BehaviorStudies 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
- Model description
- Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primary endpoint.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Bonnert, Karolinska Institutet
- Investigators
- Marianne Bonnert, PhD, Principal investigator, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Stockholm Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828302
- Sponsor's protocol ID
- EPM Dnr: 2024-06544-01
- Acronym
- iPCIT pilot
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors
- ClinicalTrials.gov ID
- NCT06828302
- Acronym / sponsor ID
- iPCIT pilot / EPM Dnr: 2024-06544-01
- Conditions
- Disruptive Behavior
- Keywords
- Internet-CBT, Parent, Children, Parent-Child Interaction Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 14 Feb 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 goal of this feasibility study is to evaluate feasibility of Internet-delivered Parent-Child Interaction Therapy for parents of children 2-7 years with disruptive behaviors. The main questions it aims to answer are:
- Could a brief online version of PCIT (iPCIT) be feasible for reducing disruptive behaviors and internalizing problems in young children, and for improving the quality of parent-child interaction?
- How is iPCIT experienced by participating parents?
Participants will receive a 10-week online intervention of Parent-Child Interaction Therapy and answer questionnaires online weekly.
Detailed description
Severe early behavioral problems increase the risk of impaired functioning in childhood and later life. Parent-Child Interaction Therapy (PCIT) is particularly effective for young children (age 2-7) with disruptive behaviors but is unimplemented in Sweden. Barriers to PCIT implementation include time constraints for parents and therapist challenges. An abbreviated internet-delivered version, iPCIT, may address these barriers. The objective of the study is to evaluate feasibility and acceptability of iPCIT.
Research questions
This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 10 weekly modules delivered over the Internet with guided support from an experienced CBT-trained psychologist and 5 biweekly videosessions where parents practice parental skills in a play situation with their child while receiving feedback and support from their therapist.
Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Twenty participants (parents of children aged 2-7 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed), any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze long term clinical effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| iPCIT | Other | Behavioral: Internet-delivered Parent-Child Interaction TherapyOnline parent management training (PMT) to teach parental skills (10 weekly online modules) combined with videosession for coaching of parental skills (5 biweekly sessions) |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2-7 years
- Disruptive behaviors as assessed with Eyberg Child Behavior Inventory (ECBI) ≥126 for boys and ≥121 for girls (which corresponds to the 90th percentile according to Swedish norms)
- Language ability equivalent to at least an average 2-year-old, defined as a vocabulary of ≥ 25 word and ability to understand simple instructions, assessed with a language screening form
Key exclusion criteria (4 listed)
- Severe autism spectrum condition (autism level 2 or 3 or equivalent functioning)
- parents who are not proficient enough in the Swedish language to complete questionnaries and receive therapy without an interpreter
- Presence of severe parental psychiatric disorders such as psychosis or suicidal ideations
- Ongoing severe psychosocial distress such as custody dispute.
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 |
|---|---|---|
| Internet-delivered Parent-Child Interaction TherapyAlso: Internet-CBT, Internet-delivered cognitive behavior therapyParent management training delivered online where Internet-modules are combined with video sessions for live coaching. | Behavioural | iPCIT |
Primary outcome
Eyberg Child Behavior Inventory
Time frame: From pretreatment to 18 weeks
Caregiver report form measuring disruptive behaviors in children. 36 items with answers ranging from 1 (never) to 7 (always). Minimum value: 36. Maximum value: 252. A higher score means worse outcome.
8 secondary outcomes
Weekly assessment of Child Behavior Forms
Time frame: From pretreatment to 18 weeks
Child Behavior Checklist
Time frame: From pretreatment to 10 weeks
Dyadic Parent-Child Interaction Coding System
Time frame: From pretreatment to 10 weeks
Brunnsviken Brief Quality of Life Scale
Time frame: From pretreatment to 18 weeks
Perceived Stress Scale
Time frame: From pretreatment to 18 weeks
Parental Stress Scale
Time frame: From pretreatment to 18 weeks
Difficulties in Emotion Regulation Scale
Time frame: From pretreatment to 18 weeks
Parenting Young Children Scale
Time frame: From pretreatment to 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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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. This study is not recruiting at the moment.
Marianne Bonnert, PhD principal investigator
Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Stockholm Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Parent-Child Interaction Therapy in people with Disruptive Behavior, run by Karolinska Institutet at 1 site 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 4 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory (time frame: From pretreatment to 18 weeks). 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 25 Jun 2026.