Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorKarolinska Institutet
About this trial
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:
1. How feasible and acceptable is the implementation of brief PCIT-VR in Sweden? 2. What are the preliminary effects of brief PCIT-VR? 3. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Child aged 2-7 years
Elevated disruptive behavior (ECBI score >114)
Parent speaks Swedish or English
Disqualifiers
Child or family requiring more urgent intervention
Parent condition that prevents VR use (e.g., epilepsy, severe migraine, adverse VR experiences)
Trial design
Design model
Single group
Treatments tested in this trial
Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-films
Behavioral10 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Brief Parent-Child Interaction Therapy with videos and virtual reality (360-degree VR)-filmsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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)2
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.
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)3
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.
Time frame
Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10).Secondary outcomes
1
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.
Time frame
Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10)2
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.
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)3
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.
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)4
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.
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)Other outcomes
1
Post treatment satisfaction on the Therapy Attitude Inventory
Parent-rated therapy satisfaction is evaluated with the Therapy Attitude Inventory, which includes 10 items, each rated between 1 to 5. Total sum ranges between 10-50, where a higher score indicates more satisfaction with treatment.
Time frame
Post-treatment (treatment phase 10 weeks)2
Parental experiences of the treatment explored through individual qualitative interviews
Qualitative interviews will explore parent's experiences of participating in the treatment and of using parental strategies, and includes questions about experienced effectiveness, feasibility, satisfaction. Three questions target helpfulness, relevance and usefulness, and are rated 0-10. Total sum ranges between 0-30, with higher scores indicating greater levels of usefulness.
Time frame
Post-treatment (treatment phase 10 weeks)3
Clinician experiences of the treatment explored through individual qualitative interviews
Qualitative interviews will explore clinicians' experiences of the treatment and includes questions about experienced effectiveness, feasibility, satisfaction.
Time frame
Post-treatment (treatment phase 10 weeks)4
Caregiver: Background information
A few questions on caregiver and child background.
Time frame
First weekly assessment (baseline phase week 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov
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