Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386562
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-04-08
Brief Title:
Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Step by Step - Pilot Study of an Internet-based Parenting Program for Aggressive Disruptive Behavior in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot randomized controlled trial is to learn about effects and experiences of an internet-based parenting program for parents of children and adolescents with behavioral problems eg aggressive or defiant behavior
The main questions the study aims to answer are
What are the preliminary effects of the internet-based parenting program
What is the level of parents engagement in the parenting program
How do parents perceive the program
Families will be randomized to a version of an internet-based parenting program with support provided from family guides psychologists through chat messages in the program or to the same internet-based parenting program with additional phonedigital support-meetings Parents will answer quantitative measurements questions before during and after treatment Parents will also be asked to participate in a qualitative interview after the program Both within and between group comparisons will be conducted to see if there are trends within each arm and differences between the two types of support
The main questions the study aims to answer are
What are the preliminary effects of the internet-based parenting program
What is the level of parents engagement in the parenting program
How do parents perceive the program
Families will be randomized to a version of an internet-based parenting program with support provided from family guides psychologists through chat messages in the program or to the same internet-based parenting program with additional phonedigital support-meetings Parents will answer quantitative measurements questions before during and after treatment Parents will also be asked to participate in a qualitative interview after the program Both within and between group comparisons will be conducted to see if there are trends within each arm and differences between the two types of support
Detailed Description:
BACKGROUND
Some children with behavior problems eg aggressive and defiant behaviors are at elevated risk for continued behavioral problems and for developing more serious forms of antisocial behaviors as well as difficulties with peers school and mental health issues Early and effective interventions are needed to reduce the risk of behavioral problems escalating over time
Parenting programs can be a first intervention for parents with children under 12 years old with oppositional defiant disorder or conduct disorder or for parents of teenagers with less severe behavioral problems Several parenting programs that show effectiveness in addressing behavioral problems are based on social learning theory and Cognitive Behavioral Therapy CBT One aim of parenting programs is to reduce negative interactions between parents and children eg inconsistent strict and insensitive parenting and to increase positive interactions eg engagement showing support and encouragement Examples of evaluated parenting programs for behavioral problems include Family Check-Up FCU The Incredible Years and the Swedish parenting program Comet
Generally internet-based interventions have become increasingly available as a treatment option for families These have the advantage of being easily accessible possible to go through at a convenient time reaching people in areas where certain interventions are not available and can be provided at a low cost The internet-based models often include some form of support from a therapistfamily guide who assists the parents There are several promising internet-based parenting programs for parents of children with behavioral problems In Sweden the internet-based parenting support iComet for parents of children aged 3-12 years with behavior problems has been developed based on the Swedish face-to-face parenting program Comet as well as the ParentWeb for parents of teenagers targeting parents of youth with subclinical levels of behavior problems However there are few internet-based parenting programs for parents of school-age children and adolescents with early signs of behavior problems
PURPOSE AND RESEARCH QUESTIONS
The purpose of the present project is to conduct a first evaluation of a newly developed internet-based parenting program based on the FCU and CBT strategies targeting parents of children between 8-16 years The aim is to quantitatively explore preliminary effects and qualitatively explore parents experiences of the program The aim is also to gain knowledge on whether the support received through the internet-based parenting program and chat support in the program with a family guide psychologist is perceived as sufficient or if additional digitalphone-based meetings with a family guide psychologist are more effective and perceived as more helpful
Research questions are the following
1 What is the preliminary effect of the internet-based parenting program on childrens behavioral problems emotional and general well-being parents emotion regulation parenting strategies and family conflicts
2 What is the level of parents engagement in the parenting program ie how many modules exercises homework tasks are completed how much time does it take to complete the program and what is the dropout rate
3 Do parents perceive that they learn relevant strategies that the parenting program is effective acceptable useful and how is the collaboration with the family guide perceived Do parents experience any adverse effects
4 Is there any difference in the experience and satisfaction with the program collaboration with the family guide parents motivation dropout rate completion of exercises homework tasks or trends in the effectiveness of the parenting program depending on whether additional digitalphone-based meetings with the family guide are also included
METHOD
This is a small randomized controlled pilot study based on a mixed-methods approach Evaluation is conducted using repeated measurements and both within- and between-group comparisons
Parents from various parts of Sweden can participate The study is advertised and parents are informed about the study on a website and can contact the responsible researchers for more information Both caregivers have to give written informed consent to participate When parents are interested in participating inclusion and exclusion criteria are reviewed in a telephone call Included families are randomized to receive either 1 Internet-based parenting program with support from a family guide via chat function or 2 The same internet-based parenting program along with digitalphone meetings with a family guide
The interventions are evaluated using validated self-report questionnaires distributed online through a secure web-platform before and after the program as well as through a telephone interview after the intervention with participants willing to participate in these One or both caregivers can complete the evaluation before and after the parenting program and participate in the qualitative interview Interviews are recorded and transcribed
POWER CALCULATION
The primary aim of this pilot study is to investigate experiences of the parenting program approaches The quantitative and qualitative data collected about each approach with ten families in each condition ie 20 families in total in a pre-post analysis of quantitative data are considered sufficient to provide an in-depth understanding and preliminary insight into effects acceptability usability relevance and effectiveness of the interventions
ANALYSES
The qualitative analyses will be conducted using content analysis or thematic analysis For the quantitative analyses changes within and between groups will be evaluated using paired t-tests repeated measures ANOVA andor Generalized Linear Mixed Models GLMM If needed non-parametric alternatives will be employed
Some children with behavior problems eg aggressive and defiant behaviors are at elevated risk for continued behavioral problems and for developing more serious forms of antisocial behaviors as well as difficulties with peers school and mental health issues Early and effective interventions are needed to reduce the risk of behavioral problems escalating over time
Parenting programs can be a first intervention for parents with children under 12 years old with oppositional defiant disorder or conduct disorder or for parents of teenagers with less severe behavioral problems Several parenting programs that show effectiveness in addressing behavioral problems are based on social learning theory and Cognitive Behavioral Therapy CBT One aim of parenting programs is to reduce negative interactions between parents and children eg inconsistent strict and insensitive parenting and to increase positive interactions eg engagement showing support and encouragement Examples of evaluated parenting programs for behavioral problems include Family Check-Up FCU The Incredible Years and the Swedish parenting program Comet
Generally internet-based interventions have become increasingly available as a treatment option for families These have the advantage of being easily accessible possible to go through at a convenient time reaching people in areas where certain interventions are not available and can be provided at a low cost The internet-based models often include some form of support from a therapistfamily guide who assists the parents There are several promising internet-based parenting programs for parents of children with behavioral problems In Sweden the internet-based parenting support iComet for parents of children aged 3-12 years with behavior problems has been developed based on the Swedish face-to-face parenting program Comet as well as the ParentWeb for parents of teenagers targeting parents of youth with subclinical levels of behavior problems However there are few internet-based parenting programs for parents of school-age children and adolescents with early signs of behavior problems
PURPOSE AND RESEARCH QUESTIONS
The purpose of the present project is to conduct a first evaluation of a newly developed internet-based parenting program based on the FCU and CBT strategies targeting parents of children between 8-16 years The aim is to quantitatively explore preliminary effects and qualitatively explore parents experiences of the program The aim is also to gain knowledge on whether the support received through the internet-based parenting program and chat support in the program with a family guide psychologist is perceived as sufficient or if additional digitalphone-based meetings with a family guide psychologist are more effective and perceived as more helpful
Research questions are the following
1 What is the preliminary effect of the internet-based parenting program on childrens behavioral problems emotional and general well-being parents emotion regulation parenting strategies and family conflicts
2 What is the level of parents engagement in the parenting program ie how many modules exercises homework tasks are completed how much time does it take to complete the program and what is the dropout rate
3 Do parents perceive that they learn relevant strategies that the parenting program is effective acceptable useful and how is the collaboration with the family guide perceived Do parents experience any adverse effects
4 Is there any difference in the experience and satisfaction with the program collaboration with the family guide parents motivation dropout rate completion of exercises homework tasks or trends in the effectiveness of the parenting program depending on whether additional digitalphone-based meetings with the family guide are also included
METHOD
This is a small randomized controlled pilot study based on a mixed-methods approach Evaluation is conducted using repeated measurements and both within- and between-group comparisons
Parents from various parts of Sweden can participate The study is advertised and parents are informed about the study on a website and can contact the responsible researchers for more information Both caregivers have to give written informed consent to participate When parents are interested in participating inclusion and exclusion criteria are reviewed in a telephone call Included families are randomized to receive either 1 Internet-based parenting program with support from a family guide via chat function or 2 The same internet-based parenting program along with digitalphone meetings with a family guide
The interventions are evaluated using validated self-report questionnaires distributed online through a secure web-platform before and after the program as well as through a telephone interview after the intervention with participants willing to participate in these One or both caregivers can complete the evaluation before and after the parenting program and participate in the qualitative interview Interviews are recorded and transcribed
POWER CALCULATION
The primary aim of this pilot study is to investigate experiences of the parenting program approaches The quantitative and qualitative data collected about each approach with ten families in each condition ie 20 families in total in a pre-post analysis of quantitative data are considered sufficient to provide an in-depth understanding and preliminary insight into effects acceptability usability relevance and effectiveness of the interventions
ANALYSES
The qualitative analyses will be conducted using content analysis or thematic analysis For the quantitative analyses changes within and between groups will be evaluated using paired t-tests repeated measures ANOVA andor Generalized Linear Mixed Models GLMM If needed non-parametric alternatives will be employed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None