Clinical trial NCT06828302: Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors
Official title: Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disruptive Behavior
Keywords: Internet-CBT
Parent
Children
Parent-Child Interaction Therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primary endpoint.
Primary purpose: TREATMENT

Brief 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. 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?
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: From pretreatment to 18 weeks
Secondary outcomes:
measure: Weekly assessment of Child Behavior Forms
timeFrame: From pretreatment to 18 weeks
measure: Child Behavior Checklist
timeFrame: From pretreatment to 10 weeks
measure: Dyadic Parent-Child Interaction Coding System
timeFrame: From pretreatment to 10 weeks
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: From pretreatment to 18 weeks
measure: Perceived Stress Scale
timeFrame: From pretreatment to 18 weeks
measure: Parental Stress Scale
timeFrame: From pretreatment to 18 weeks
measure: Difficulties in Emotion Regulation Scale
timeFrame: From pretreatment to 18 weeks
measure: Parenting Young Children Scale
timeFrame: From pretreatment to 18 weeks
Other outcomes:
measure: Working Alliance Inventory
timeFrame: Treatment week 3
measure: Credibility Rating Scale
timeFrame: Treatment week 3
measure: The Client Satisfaction Questionnaire
timeFrame: Posstreatment (treatment week 10)
measure: Subjective Adequate Relief Questionnaire
timeFrame: Posstreatment (treatment week 10)
measure: Adverse events questionnaire
timeFrame: Posstreatment (treatment week 10)
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research, Karolinska Institutet
Study officials:
affiliation: Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Stockholm Sweden
name: Marianne Bonnert, PhD
role: PRINCIPAL_INVESTIGATOR
References: