Condition category
Mental and Behavioural Disorders
Date applied
14/12/2011
Date assigned
02/02/2012
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Adolescent antisocial behavior is known to lead to psychosocial difficulties during adolescence and adulthood. A way to reach at-risk adolescents is through the parents. Parent training has shown to be effective in changing the child’s behavior and mental health during adolescence. In this study, two parent programs are compared, ParentSteps and Comet, which target parents of at-risk adolescents aged 12 - 18 years. The aims of the programs are to train parents to help their adolescents to change their problem behavior, and to teach parents to encourage pro-social behavior. The aim of the study was to find out if either of the programs is effective in decreasing the levels of antisocial behaviour, such as substance use and delinquency, and in increasing the levels of social functioning.

Who can participate?
Two-hundred and forty families and adolescents participated in the study. Only families where the parent reported a certain level of antisocial behaviour in the adolescent could participate.

What does the study involve?
Families where randomly allocated to one of the following groups for training sessions:
1. ParentSteps
2. Comet
3. Six months waiting list control group.
Only parents participated in the parent training sessions, but both parents and adolescents answered questionnaires about the adolescents’ problem behaviour.

What are the possible benefits and risks of participating?
Parents could participate in training for free, exchange parental experiences with others in the group, and improve parental skills and techniques to change the adolescents' problem behaviour.
Youths would benefit from improved family relations. There were no known risks associated with participating in this study.

Where is the study run from?
Stockholm Centre for Psychiatric Research and Education, Sweden

When is the study starting and how long is it expected to run for?
August 2008 to June 2010

Who is funding the study?
Swedish Ministry of Health and Social Affairs and the Swedish National Board of Health and Welfare.

Who is the main contact?
Camilla Jalling
camilla.jalling@sll.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anders Tengstrom

ORCID ID

Contact details

Research Centre for Psychosocial Health at Stockholm Centre for Psychiatric Research and Education
Stockholm County Council Health Care Provision and Karolinska Institutet
Danderyds sjukhus
Hus 40
Plan 1
Danderyd
182 87
Sweden
-
anders.tengstrom@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of two parent training programs for reducing adolescent's antisocial behavior: a randomized controlled trial

Acronym

Study hypothesis

Both the intervention groups, who were assigned to receive either ParentSteps or Comet, will get decreased levels of antisocial behaviour, compared to control group, and increased levels in psychosocial functioning.

Ethics approval

Regional Ethical Board, Karolinska Institute, Stockholm, 25/06/2008, ref: 2008/744-31/5

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please contact Camilla Jalling at camilla.jalling@sll.se to request the patient information sheet

Condition

Antisocial behavior and low psycho-social functioning

Intervention

Two intervention groups (Comet and ParentSteps) and a waiting list control group:

Two parent training programs, based on Swedish modified versions of Parent Management Training (Comet), and Strengthening Families Program for parents and youths 10-14 (SFP10-14) (ParentSteps).

The Comet program format is held by two certified group leaders in nine compulsory sessions and one optional within six months after last session.

ParentSteps program format comprises of six compulsory sessions lead by two trained leaders.

Data were collected at baseline, and at six and twelve months after baseline, by both parents and adolescents. The control group was measured at only baseline and the six-month follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Adolescent externalizing behavior, using:
1. Adolescent Self-Report Delinquency Scale (SRD) to measure the quantity of criminal activities during the last six months, on a 0 to 9 times or more numerical scale
2. Youth Self-Report (YSR/CBCL) to describe externalized and internalized anti-social behavior based on the preceding six months, on a 3-point Likert scale ( 0=not true, 1=somewhat or sometimes true, 2=very true or very often true). For parents, the parent version CBCL was used for assessing parents’ reports of their adolescents’ anti-social behavior
3. Alcohol Use Disorder Identification Test (AUDIT) for measuring alcohol risk consumption
4. Drug Use Disorder Identification Test (DUDIT) for measuring drug consumption

Secondary outcome measures

Adolescent psychosocial functioning, using:
Youth Outcome Questionnaire (Y-OQ®), adolescent and parent version, based on the preceding seven days, to assess treatment progress concerning psychosocial and mental functioning, rated on a 5-point Likert scale

Overall trial start date

20/08/2008

Overall trial end date

20/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents or other caregiver, and their adolescent aged 12-18
2. Living in Stockholm
3. Youth showing signs of antisocial behavior (ex criminal activities, mobbing others, repeated conflict about family rules, substance use (alcohol, tobacco and/or drugs)
4. Youth showing signs of low psychosocial functioning

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

240

Participant exclusion criteria

Youth should not:
1. Be in psychotherapy
2. Be in treatment at alcohol treatment care center
3. Be placed in institution or family home, at the time for signing up for participation in the trial
4. Parents could not be in any other parental program at the time for signing up for particiaption in the trial

Recruitment start date

20/08/2008

Recruitment end date

20/06/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Research Centre for Psychosocial Health at Stockholm Centre for Psychiatric Research and Education
Danderyd
182 87
Sweden

Sponsor information

Organisation

Stockholm Prevents Alcohol and Drug Problems (STAD) (Sweden)

Sponsor details

Centrum för Psykiatriforskning Stockholm
Stockholm Centre for Psychiatric Research and Education
Stockholms läns sjukvårdsområde/Karolinska Institutet
Box 6031
Stockholm
102 31
Sweden

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The National Drug Policy Coordinator, Ministry of Health and Social Affairs (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Socialstyrelsen (ref: 00-106/08-4)

Alternative name(s)

National Board of Health and Welfare

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Sweden

Funder name

Stockholm City Council, Stockholm FoU within Social Development Unit (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Council for Information on Alcohol and Other Drugs/Systembolaget Research Board (Sweden) ref: 10-28:1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Council for Working life and Social Research (FAS) (Sweden) ref: 2009-1705

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Sweden

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26900316

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.