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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04670185
Other study ID # 2020-05262
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date April 15, 2021

Study information

Verified date April 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to evaluate the efficacy of a 5-week, therapist-guided, internet-delivered parent management training program (BIP SAMBA) targeting children aged 5 - 11 years with externalising behavior problems. The study is a randomised controlled trial with parents of N=30 children participating. The intervention BIP SAMBA is compared with a waitlist control condition. Participants in the control condition will be crossed over to the active treatment after 5 weeks. The primary outcome measure is the Eyberg Child Behavior Inventory (ECBI) at the post treatment (5 weeks after baseline assessment).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 11 Years
Eligibility Inclusion Criteria: - Being parent of a child between 5 and 11 years - This child has externalising behavior problems - The parent has access to the internet - The parent speaks and write Swedish Exclusion Criteria: - The child has an autism diagnosis - The child has severe conduct problems - There is domestic violence occurring within the family - There alcohol or substance abuse occurring within the family

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BIP SAMBA
Behavioral parent management training

Locations

Country Name City State
Sweden BUP CPF Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eyeberg Child Behavior Inventory (ECBI) Measures externalising behavior problems in children; Min: 0 Max 216; A higher score indicates worse conduct problems. Change in conduct problems from baseline (week 0) to post-treatment (week 6)
Secondary Strength and Difficulties Questionnaire (SDQ) Measures conduct problems, emotional problems, ADHD symptoms, peer problems and prosocial behaviours; Min: 0 Max: 40p; A higher score indicate worse mental health problems Screens for behavioral problems, emotional problems, ADHD symptoms, peer problems and pro social behaviours Change in mental health issues from baseline (week 0) to post-treatment (week 6)
Secondary Alabama Parenting Questionnaire (APQ) Measures parenting strategies; Min: 0 Max: 76; A higher score indicates worse parenting strategies Change in parenting strategies from baseline (week 0) to post-treatment (week 6)
Secondary Client Satisfaction Questionnaire (CSQ) Measures satisfaction with a treatment that has been received; Min: 0 Max: 24; A higher score indicates better satisfaction with the treatment At post-treatment (week 6)
Secondary Weekly questions about frequency of and impairment from behavior problems Participants rate these two questions every week throughout the treatment; Min 0 Max: 9; A higher score indicates worse behavior problems Changes in behavior problems from baseline to week 5
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