Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy
- Conditions
- Disruptive BehaviorConduct Disorders in ChildrenOppositional Defiant Disorder
- Registration Number
- NCT07201090
- Lead Sponsor
- Karolinska Institutet
- Brief 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. 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.
- 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:
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?
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- Child aged 2-7 years
- Elevated disruptive behavior (ECBI score >114)
- Parent speaks Swedish or English
- Child or family requiring more urgent intervention
- Parent condition that prevents VR use (e.g., epilepsy, severe migraine, adverse VR experiences)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory (ECBI) - Intensity scale 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.
Change from baseline phase to treatment phase in weekly reported disruptive behavior 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.
Mean change from screening in parent-ratings of child behavior problems on the Eyberg Child Behavior Inventory - Problem scale 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.
- Secondary Outcome Measures
Name Time Method Mean change from pre-treatment in parent-rated callous unemotional behaviors on the Inventory of Callous Unemotional traits (ICU) scale Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10) 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.
Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment) 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.
Mean change from pre-treatment in parent-rated stress on the Perceived Stress Scale (PSS) Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment) 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.
Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - frequency scale Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment) 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.
Mean change from pre-treatment in parent-rated parenting behaviors on the Parenting Young Children (PARYC) - problem scale Pre-treatment (treatment phase week 0), post-treatment (treatment phase week 10), and at 6-months follow-up (6 months from pre-treatment assessment) 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.
Change from baseline phase to treatment phase in weekly reported warmth and relationship quality Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10). 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.
Change from baseline phase to treatment phase in weekly reported parental anger Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10). 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.
Change from baseline phase to treatment phase in weekly reported emotion regulation Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10). 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.
Change from baseline phase to treatment phase in weekly reported consistent parenting Weekly throughout baseline phase (baseline phase week 1-4) and treatment phase (treatment phase week 1-10). 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.
Trial Locations
- Locations (2)
Karolinska Institutet
🇸🇪Solna, Sweden
Region Stockholm
🇸🇪Stockholm, Sweden
Karolinska Institutet🇸🇪Solna, SwedenPia Enebrink, PhDContact