Clinical trial NCT06386562: Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior
Official title: Step by Step - Pilot Study of an Internet-based Parenting Program for Aggressive, Disruptive Behavior in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Disruptive Behavior
Oppositional Defiant Disorder
Conduct Problems
Parent-Child Relations
Keywords: Disruptive Behavior
Child Behavior Problem
Parenting
Internet-based parent training
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (e.g., 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 phone/digital 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 (e.g., 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 (e.g., inconsistent, strict, and insensitive parenting) and to increase positive interactions (e.g., 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 therapist/family 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 digital/phone-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 children's 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, i.e., 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 digital/phone-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 digital/phone 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, i.e., 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, and/or Generalized Linear Mixed Models (GLMM). If needed, non-parametric alternatives will be employed.

Eligibility criteria: Inclusion Criteria:

* Parent of a child aged 8-16 years
* The parent perceives that the child gets angry easily, displays defiant behaviors, or that there are parent-child conflicts at home.
* The parent is able to access information in Swedish (the program is currently only in Swedish).

Exclusion Criteria:

* Parent of a child under 8 years or over 16 years of age
* The child does not currently have angry, aggressive, or defiant behaviors.
* The child has autism, severe depression, suicidal thoughts, psychosis, or an eating disorders.
* The parent does not speak Swedish.

Primary outcomes:
measure: Mean change from baseline in behavior problems on the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale: Impact scale
timeFrame: Pre- and post-intervention (after 7 weeks)
Secondary outcomes:
measure: Mean change from baseline in child wellbeing on the KIDSCREEN-10
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change from baseline in child wellbeing on the Strengths and Difficulties Questionnaire
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change from baseline in emotion regulation on the Difficulties in Emotion Regulation Scale
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change in family warmth
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change in family conflicts
timeFrame: Pre- and post-intervention (after 7 weeks)
measure: Mean change in parental satisfaction with the week
timeFrame: From baseline to post-intervention (after 7 weeks). Completed once a week when a new program module is accessed.
measure: Parental experiences of the internet-based parenting program explored through qualitative interviews
timeFrame: Interviews are conducted after the internet-based parenting program is completed, between 7 to 12 weeks after the initiation of the program
measure: Parental experiences of each module in the internet-based parenting program
timeFrame: From baseline to post-intervention (after 7 weeks). Completed once a week after working with a new module.
measure: Parental experiences of the whole internet-based parenting program
timeFrame: Post-intervention (after 7 weeks)
measure: Parental use of the internet-based parenting program: homework tasks, exercises
timeFrame: From pre- to post-intervention (measured after 7 weeks)
measure: Parental use of the internet-based parenting program: time spent working with the program
timeFrame: From pre- to post-intervention (measured after 7 weeks)
measure: Parental use of the internet-based parenting program: drop out rate
timeFrame: From baseline to post intervention (measured after 7 weeks)
Other outcomes:
measure: Background information
timeFrame: Pre-intervention
measure: Working alone or with partner in the parenting program
timeFrame: Post-intervention (after completion of the final module, 5-7 weeks after baseline)
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Pia Enebrink, PhD
role: PRINCIPAL_INVESTIGATOR
References: