Centre for Psychiatry Research, Karolinska Institutet
Stockholm, Sweden
NCT Number: NCT06828302
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.
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Notify Me2 year–7 year
All sexes
Interventional
Not applicable
Stockholm, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Parent management training delivered online where Internet-modules are combined with video sessions for live coaching.
Other names: Internet-CBT, Internet-delivered cognitive behavior therapy
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
Time frame: Posstreatment (treatment week 10)
Short 6-item questionnaire to identify if any adverse events have occurred due to treatment
Karolinska Institutet
Other
Acronym: iPCIT pilot
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