- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06828302
Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors (iPCIT pilot)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden
- Centre for Psychiatry Research, Karolinska Institutet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: iPCIT
Online parent management training (PMT) to teach parental skills (10 weekly online modules) combined with videosession for coaching of parental skills (5 biweekly sessions)
|
Parent management training delivered online where Internet-modules are combined with video sessions for live coaching.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From pretreatment to 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyadic Parent-Child Interaction Coding System
Time Frame: From pretreatment to 10 weeks
|
Observation System measuring parental behavior and child behavior.
The frequency of specified behaviors are measured during a five minute long standardized play situation.
|
From pretreatment to 10 weeks
|
|
Weekly assessment of Child Behavior Forms
Time Frame: From pretreatment to 18 weeks
|
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.
|
From pretreatment to 18 weeks
|
|
Child Behavior Checklist
Time Frame: From pretreatment to 10 weeks
|
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.
|
From pretreatment to 10 weeks
|
|
Brunnsviken Brief Quality of Life Scale
Time Frame: From pretreatment to 18 weeks
|
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.
|
From pretreatment to 18 weeks
|
|
Perceived Stress Scale
Time Frame: From pretreatment to 18 weeks
|
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.
|
From pretreatment to 18 weeks
|
|
Parental Stress Scale
Time Frame: From pretreatment to 18 weeks
|
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.
|
From pretreatment to 18 weeks
|
|
Difficulties in Emotion Regulation Scale
Time Frame: From pretreatment to 18 weeks
|
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.
|
From pretreatment to 18 weeks
|
|
Parenting Young Children Scale
Time Frame: From pretreatment to 18 weeks
|
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.
|
From pretreatment to 18 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Adequate Relief Questionnaire
Time Frame: Posstreatment (treatment week 10)
|
Questionnaire that measures self-perceived change in symptoms as a result of the treatment.
The scale consists of 1 item rated from 0 (much worse) to 6 (much better).
|
Posstreatment (treatment week 10)
|
|
Adverse events questionnaire
Time Frame: Posstreatment (treatment week 10)
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Short 6-item questionnaire to identify if any adverse events have occurred due to treatment
|
Posstreatment (treatment week 10)
|
|
Working Alliance Inventory
Time Frame: Treatment week 3
|
Questionnaire measuring alliance with therapist.
6 items scored on a scale from 1 (never) to 7 (always).
Minimum value: 6. Maximum value: 42.
A higher score means better outcome.
|
Treatment week 3
|
|
Credibility Rating Scale
Time Frame: Treatment week 3
|
Questionnaire measuring treatment credibility.
5 items scored on a scale from 0 (not at all) to 10 (very).
Minimum value: 0. Maximum value: 50.
A higher score means better outcome.
|
Treatment week 3
|
|
The Client Satisfaction Questionnaire
Time Frame: Posstreatment (treatment week 10)
|
Questionnaire measuring satisfaction with treatment.
8 items with answers ranging from 1 (bad) to 4 (very good).
Minimum value: 8. Maximum value: 32.
A higher score means better outcome.
|
Posstreatment (treatment week 10)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marianne Bonnert, PhD, Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Stockholm Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPM Dnr: 2024-06544-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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