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Internet-based Parent Training for Parents of Children With Externalising Behavior Problems (BIP-SAMBA)

Primary Purpose

Behavior Problem, Parenting

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
BIP SAMBA
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior Problem

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BUP CPF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based parent training

Waitlist

Arm Description

Five weeks of therapist-guided online delivered parents training

Five weeks of waitlist

Outcomes

Primary Outcome Measures

Eyeberg Child Behavior Inventory (ECBI)
Measures externalising behavior problems in children; Min: 0 Max 216; A higher score indicates worse conduct problems.

Secondary Outcome Measures

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
Alabama Parenting Questionnaire (APQ)
Measures parenting strategies; Min: 0 Max: 76; A higher score indicates worse parenting strategies
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
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

Full Information

First Posted
December 9, 2020
Last Updated
April 22, 2021
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04670185
Brief Title
Internet-based Parent Training for Parents of Children With Externalising Behavior Problems
Acronym
BIP-SAMBA
Official Title
Internet-based Parent Training for Parents of Children With Externalising Behavior Problems: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Parenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based parent training
Arm Type
Experimental
Arm Description
Five weeks of therapist-guided online delivered parents training
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Five weeks of waitlist
Intervention Type
Behavioral
Intervention Name(s)
BIP SAMBA
Intervention Description
Behavioral parent management training
Primary Outcome Measure Information:
Title
Eyeberg Child Behavior Inventory (ECBI)
Description
Measures externalising behavior problems in children; Min: 0 Max 216; A higher score indicates worse conduct problems.
Time Frame
Change in conduct problems from baseline (week 0) to post-treatment (week 6)
Secondary Outcome Measure Information:
Title
Strength and Difficulties Questionnaire (SDQ)
Description
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
Time Frame
Change in mental health issues from baseline (week 0) to post-treatment (week 6)
Title
Alabama Parenting Questionnaire (APQ)
Description
Measures parenting strategies; Min: 0 Max: 76; A higher score indicates worse parenting strategies
Time Frame
Change in parenting strategies from baseline (week 0) to post-treatment (week 6)
Title
Client Satisfaction Questionnaire (CSQ)
Description
Measures satisfaction with a treatment that has been received; Min: 0 Max: 24; A higher score indicates better satisfaction with the treatment
Time Frame
At post-treatment (week 6)
Title
Weekly questions about frequency of and impairment from behavior problems
Description
Participants rate these two questions every week throughout the treatment; Min 0 Max: 9; A higher score indicates worse behavior problems
Time Frame
Changes in behavior problems from baseline to week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
BUP CPF
City
Stockholm
ZIP/Postal Code
113 30
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Internet-based Parent Training for Parents of Children With Externalising Behavior Problems

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