Plain English Summary
Background and study aims
A common reason for referral to psychiatric treatment among school-aged children and adolescents is aggressive behavior and other conduct problems. Oppositional Defiant Disorder (ODD) describes emotional and behavioral problems when a child often loses temper, is angry, argues with adults, whereas Conduct Disorder (CD) includes more severe behaviors such as fighting, lying, stealing and playing truant from school. Children with ODD or CD are at higher risk than average of continued behavior problems. Parent management training (PMT) programs aim at helping parents develop strategies to manage their child's behavioral problems at home and at school. PMT programs have been shown to reduce the frequency and severity of behavior problems. Children with CD or ODD are at a higher risk than average of being antisocial as adults and developing psychiatric diseases. Parent Management Training (PMT) programs have been developed to train parents to manage their child's behavioural problems at home and at school. These have been shown to reduce the risk of the child continuing to be antisocial as an adult. However, some risk factors may not be addressed by a PMT program. These include hostility towards others, difficulties in problem solving and not being able to control feelings of anger. The Coping Power Program (CPP), which involves structured group and individual cognitive behaviour sessions for children and their parents, aims to address these risk factors. Here, we want to compare the performance and cost-effectiveness of a combined PMT program (a Swedish version called Komet) and CPP treatment, with that of the PMT (Comet) program on its own.
Who can participate?
Families with children aged 8 and 12 years old with behavioural problems, which have resulted in being referred to Stockholm child and adolescent psychiatric units. The child is typically diagnosed with CD or ODD.
What does the study involve?
The families are randomly allocated into one of two groups. Those in group 1 receive the PMT(Komet)/child CBT (Coping Power Program) treatment. Those in group 2 receive only the PMT (Komet) program. The families and teachers fill in questionnaires developed to monitor progress before treatment begins, just after the treatment ends, every third week during the treatment period and then 12 and 24 months after the treatment ends. The children’s level of intelligence is assessed before treatment begins.
What are the possible benefits and risks of participating?
Benefits of participating include the possibility of an improvement to the children’s behaviour. There are no notable risks of participating.
Where is the study run from?
Child and Adolescent Psychiatric clinics in Sweden.
When is the study starting and how long is it expected to run?
February 2013 to December 2018
Who is funding the study?
1. Söderström-Königska Foundation (Sweden)
2. Stockholm Child and Adolescent Psychiatry (Sweden)
Who is the main contact?
Pia Enebrink
pia.enebrink@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Pia Enebrink
ORCID ID
http://orcid.org/0000-0002-1082-683X
Contact details
Division of Psychology
Karolinska Institutet
Nobels väg 9-11
Solna
171 65
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomized controlled trial of the Parent-Management Training program and the Coping Power Program. Komet: Effects and costs of two treatments for children with conduct problems
Acronym
PMT-CPP
Study hypothesis
The combined treatment (CPP and PMT) will result in significantly less conduct problems, improved child social skills and problem-solving skills, than the treatment targeting parents only (PMT).
Ethics approval
The regional ethical committee in Stockholm, refs 2011/1587-31; 2013/1555-32; 2014/1507-32
Study design
Multi-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Patient information is in Swedish and available upon request
Condition
1. Oppositional Defiant Disorder
2. Conduct Disorder
Intervention
Families are randomized to one of two groups.
Intervention group: Participants take part in both the Coping Power Program (CPP) and Parent Management Treatment (PMT).
Control group: Participants take part in the Parent Management Treatment (PMT) alone.
The Coping Power Program (CPP) is an intervention developed for children with aggressive behavior. In the present study, the child component of the intervention is used. The treatment is conducted in a group with other children, and includes emotion awareness components as well as anger management, perspective taking and social problem solving.
The Parent Management Treatment (PMT) in the present study is based on the Swedish group-based PMT-program Komet. The Komet-program aims at helping parents develop and use parenting skills for handling their children's conduct problem behaviors.
The families participate in the interventions during 3 months. Data is collected at baseline, during the intervention (short questionnaire), after the intervention 3 months after baseline, as well as 12- and 24 months after treatment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Conduct problems measured using the Disruptive Behaviour Disorders (DBD) questionnaire, the Strengths and Difficulties Questionnaire (SDQ), the conduct problems scale and presence of ODD/CD symptoms after treatment and at 12 and 24 months.
Secondary outcome measures
Parents/teachers:
1. Child friendships and emotional well-being, measured using the Strengths and Difficulties Questionnaire (SDQ) and teacher evaluation at baseline, after treatment, 12 and 24 months
2. Child social competence and self-control, measured using the Social competence scale – parent, a modified version of the Social Skills Rating System (SSRS) and teacher evaluation at baseline, after treatment, 12 and 24 months
3. Child callous-unemotional traits are measured using the Antisocial Processing Screening Device, with one sub-scale measuring callous unemotional (CU) traits at baseline, after treatment, 12 and 24 months
4. Parent strategies measured using three sub-scales (appropriate discipline, harsh and inconsistent
discipline, praise and incentives) of the Parenting Practices Interview, at baseline, during treatment, after treatment, 12 and 24 months
5. Parent stress measured through Perceived Stress Scale (PSS) also filled in at baseline, during treatment, after treatment, 12 and 24 months
6. Parental self-efficacy and satisfaction through Parenting sense of competence scale at at baseline, after treatment, 12 and 24 months
7. Treatment alliance recorded during and after treatment
Children:
1. Child social competence and social skills measured using a modified version of the Social Skills Rating System (SSRS) at baseline and after treatment
2. Child attitude and problem-solving strategies measured using the Problem-solving measure for conflict outcome expectations questionnaire and a home interview with the child at baseline and after treatment
3. Child friendships and emotional well-being, measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline and after treatment
4. Treatment alliance is measured by a 10-graded scale after the treatment
Therapist/research assistant-rated variables:
1. Therapists register participation in treatment sessions, number of home-work completed during treatment, costs and amount of time associated with treatment
2. Risk factors are determined using the Early Assessment Risk List for Boys (EARL-20B) and Early Assessment Risk List for Girls (EARL-21G) tools at baseline and after treatment
Overall trial start date
01/02/2013
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged between 8 and 12 years
2. Diagnosis of Oppositional Defiant Disorder, Conduct Disorder or Disruptive Behavior NOS
3. Referred to child and adolescent psychiatry in Stockholm, Sweden
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
150 families
Total final enrolment
120
Participant exclusion criteria
1. Severe depression
2. Self-harming behaviors
3. Autism spectrum disorder
4. Psychosis
5. Cognitive retardation
6. Presence of violence or severe substance abuse in the family
Recruitment start date
01/01/2014
Recruitment end date
01/03/2016
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institute
Division of Psychology
Nobels väg 9
Solna
171 65
Sweden
Funders
Funder type
Research organisation
Funder name
Söderström-Königska Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stockholm Child and Adolescent Psychiatry
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of five articles aimed at international researchers, clinicians, policy makers.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29448135 (added 08/04/2020)