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

NCT06386562 | Completed

• 1 other identifier: 2023-07489-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Mean change from baseline in behavior problems on the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).

  The oppositional defiant disorder subscale of the Disruptive Behavior Disorder scale is used for assessing children's behavioral problems. The subscale includes 8 items, rated on a 4-point scale (0 to 3). The scale sum ranges från 0 to a total maximum sum of 24. A higher score indicates more severe behavior problems.

  Pre- and post-intervention (after 7 weeks)

• Mean change from baseline in parenting on the Parenting Children and Adolescents Scale

  Subscales: encouragement of positive behaviors, setting limits, proactive parenting behaviors. The 21 items are here scored on a 5-point scale (1 to 5) and the total scale sum ranges from 21 to a maximum of 105, with a higher score indicating more positive parenting.

  Pre- and post-intervention (after 7 weeks)

• Mean change from baseline in parenting on the Parenting Children and Adolescents Scale: Impact scale

  Each of the 21 items in the Parenting Children and Adolescents Scale also includes a question whether it is experienced as a problem (yes/no). Total scale sum ranges between 0 and 21, with a higher sum indicating larger problems and impact.

  Pre- and post-intervention (after 7 weeks)

Secondary Outcomes (13)

• Mean change from baseline in child wellbeing on the KIDSCREEN-10

  Pre- and post-intervention (after 7 weeks)

• Mean change from baseline in child wellbeing on the Strengths and Difficulties Questionnaire

  Pre- and post-intervention (after 7 weeks)

• Mean change from baseline in emotion regulation on the Difficulties in Emotion Regulation Scale

  Pre- and post-intervention (after 7 weeks)

• Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale

  Pre- and post-intervention (after 7 weeks)

• Mean change in family warmth

  Pre- and post-intervention (after 7 weeks)

Other Outcomes (2)

• Background information

  Pre-intervention

• Working alone or with partner in the parenting program

  Post-intervention (after completion of the final module, 5-7 weeks after baseline)

Study Arms (2)

Internet-based parenting program

ACTIVE COMPARATOR

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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

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

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

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, Sweden

Location

MeSH Terms

Conditions

Problem Behavior; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pia Enebrink, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 26, 2024
• Study Start: April 29, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)