- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04670185
Internet-based Parent Training for Parents of Children With Externalising Behavior Problems (BIP-SAMBA)
April 22, 2021 updated by: Jens Högström, Karolinska Institutet
Internet-based Parent Training for Parents of Children With Externalising Behavior Problems: A Randomised Controlled Trial
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stockholm, Sweden, 113 30
- BUP CPF
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet-based parent training
Five weeks of therapist-guided online delivered parents training
|
Behavioral parent management training
|
No Intervention: Waitlist
Five weeks of waitlist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eyeberg Child Behavior Inventory (ECBI)
Time Frame: Change in conduct problems from baseline (week 0) to post-treatment (week 6)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength and Difficulties Questionnaire (SDQ)
Time Frame: Change in mental health issues from baseline (week 0) to post-treatment (week 6)
|
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)
|
Alabama Parenting Questionnaire (APQ)
Time Frame: Change in parenting strategies from baseline (week 0) to post-treatment (week 6)
|
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)
|
Client Satisfaction Questionnaire (CSQ)
Time Frame: At post-treatment (week 6)
|
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)
|
Weekly questions about frequency of and impairment from behavior problems
Time Frame: Changes in behavior problems from baseline to week 5
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2020
Primary Completion (Actual)
April 15, 2021
Study Completion (Actual)
April 15, 2021
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
December 15, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-05262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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