NCT04670185

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

December 9, 2020

Last Update Submit

April 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Strength and Difficulties Questionnaire (SDQ)

    Change in mental health issues from baseline (week 0) to post-treatment (week 6)

  • Alabama Parenting Questionnaire (APQ)

    Change in parenting strategies from baseline (week 0) to post-treatment (week 6)

  • Client Satisfaction Questionnaire (CSQ)

    At post-treatment (week 6)

  • Weekly questions about frequency of and impairment from behavior problems

    Changes in behavior problems from baseline to week 5

Study Arms (2)

Internet-based parent training

EXPERIMENTAL

Five weeks of therapist-guided online delivered parents training

Behavioral: BIP SAMBA

Waitlist

NO INTERVENTION

Five weeks of waitlist

Interventions

BIP SAMBABEHAVIORAL

Behavioral parent management training

Internet-based parent training

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUP CPF

Stockholm, 113 30, Sweden

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 17, 2020

Study Start

December 15, 2020

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations