Coping power program and parent management training for families with children with conduct problems

ISRCTN	ISRCTN10834473
DOI	https://doi.org/10.1186/ISRCTN10834473
Protocol serial number	N/A
Sponsor	Söderström-Königska Foundation (Sweden)
Funders	Söderström-Königska Foundation, Stockholm Child and Adolescent Psychiatry

Submission date: 15/10/2014
Registration date: 23/12/2015
Last edited: 04/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Pia Enebrink
Scientific

Division of Psychology
Karolinska Institutet
Nobels väg 9-11
Solna
171 65
Sweden

ORCID ID	0000-0002-1082-683X

Study information

Primary study design	Interventional
Study design	Multi-centre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PMT-CPP
Study objectives	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(s)	The regional ethical committee in Stockholm, refs 2011/1587-31; 2013/1555-32; 2014/1507-32
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	150
Total final enrolment	120
Key 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
Key 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
Date of first enrolment	01/01/2014
Date of final enrolment	01/03/2016

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institute

Division of Psychology
Nobels väg 9
Solna
171 65
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2018	08/04/2020	Yes	No
Results article	results	01/09/2020	15/09/2020	Yes	No
Results article	2-Year Follow-Up	28/01/2022	04/01/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/01/2023: Publication reference added.
15/09/2020: Publication reference added.
08/04/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.