Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior

NCT ID: NCT06386562

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2024-07-15

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.

Conditions

Child Behavior Problem; Disruptive Behavior; Oppositional Defiant Disorder; Conduct Problems; Parent-Child Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Internet-based parenting program

Internet-based parenting program with weekly parental support from a family guide (psychologist) via a chat function integrated into the program. The program consists of a brief introducing module and 5 modules conducted over 5-7 weeks. Parents work independently with material online and receive support from the family guide through chat/text messages in the program.

Group Type: ACTIVE_COMPARATOR

Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program

Intervention Type: BEHAVIORAL

The internet-based parenting support program is based on social learning theory. A foundation is the Family Check-up program (FCU), which includes approaches from motivational interviewing (MI). The parenting support is also based on similar CBT-parenting strategies as in other evaluated face-to-face CBT-parenting support programs (e.g., Comet) as well as internet-based programs (e.g., iComet; ParentWeb).

Internet-based parenting program with additional parental support through digital/phone meetings

The same internet-based parenting program with weekly parental support from a family guide (psychologist) via a chat function integrated into the program. The addition is three 10-15 minutes long digital/phone meetings between the family guide and the parent.

Group Type: EXPERIMENTAL

Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program with additional parental support

Intervention Type: BEHAVIORAL

The internet-based parenting program includes the same contents and chat-function as in the other condition. The focus for the digital/phone meetings is to explore potential questions, problem-solve around potential challenges, and motivate parents to practice strategies and complete modules.

Interventions

Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program

The internet-based parenting support program is based on social learning theory. A foundation is the Family Check-up program (FCU), which includes approaches from motivational interviewing (MI). The parenting support is also based on similar CBT-parenting strategies as in other evaluated face-to-face CBT-parenting support programs (e.g., Comet) as well as internet-based programs (e.g., iComet; ParentWeb).

Intervention Type: BEHAVIORAL

Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program with additional parental support

The internet-based parenting program includes the same contents and chat-function as in the other condition. The focus for the digital/phone meetings is to explore potential questions, problem-solve around potential challenges, and motivate parents to practice strategies and complete modules.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Pia Enebrink

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Enebrink, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Solna, , Sweden

Countries

Sweden

Other Identifiers

2023-07489-01

Identifier Type: -

Identifier Source: org_study_id