Plain English Summary
Background and study aims
Alcohol and drug use among adolescents are key factors for premature death and disease. Prolonged use of substances leads to negative psychological, physiological and social effects. In addition to the individual risks connected to substance use, the network (for example parents and concerned significant others) are at higher risk of psychological conditions, such as depression and anxiety.
Research shows that help-seeking at a care provider help people resolve their substance use problem. However, young people with problematic substance use often refrain from seeking treatment.
Support programs for concerned significant others have proven effective in adult populations. However, less is known about support programs aimed for caregivers of substance using adolescents. Therefore, support programs that target the likelihood of treatment seeking among adolescents as well as health of the guardians needs to be evaluated. The aim of the study is to investigate the efficacy of CRAFT for caregivers to adolescents suffering from substance use disorder (SUD), regarding treatment seeking behaviour and substance use for adolescents, as well as mental health for caregivers.
Who can participate?
Formal or informal caregivers of adolescents with alcohol or drug use.
How is the study designed?
Participants are randomly allocated to one of two groups. Group 1 receive counseling according to an extended program of the currently used model at Mini Maria, and includes five individual counseling sessions and one cannabis group education session.
Group 2 receive counseling based on a structured method including different themes, developed for concerned significant others of people with substance problems, and includes eight individual counseling sessions. All participants will answer questions about their health related status and their adolescents health related status and substance use at four time points, when they enter the study, six weeks, 12 weeks and 24 weeks later.
What are the potential benefits and risks with participating?
All study participants are offered support in a difficult situation. The participants presumably acquire more adequate tools to handle the situation, leading to improvements in the health and wellbeing of both the adolescent and the caregiver.
There are no direct risks of physical harm connected to participation in this study.
Where is the study run from?
Stockholm Centre for Dependency Disorders (Sweden)
When will the study start and how long will it run?
October 2018 to October 2020
Who is funding the study?
The Public Health Agency of Sweden (Sweden)
Who is responsible for the study?
Anders Hammarberg
anders.hammarberg@ki.se
Trial website
Contact information
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2018/1642-31
Study information
Scientific title
Community Reinforcement Approach and Family Training (CRAFT) administered to caregivers of substance using adolescents: a randomized controlled trial
Acronym
CRAFT
Study hypothesis
Primary hypothesis:
Participation in a CRAFT program for caregivers increases the probability of treatment seeking in adolescents with substance-related problems compared to treatment as usual
Secondary hypotheses
1. Participation in a CRAFT program for guardians reduces youth's drug and alcohol consumption compared to treatment as usual
2. Participation in a CRAFT program for guardians leads to improved mental health for the participant and youth compared to usual care
3. Participation in a CRAFT program for guardians provides an increased relational satisfaction for the participant compared to treatment as usual
4. Participation in a CRAFT program for guardians gives an increased quality of life for the participant compared to treatment as usual
5. Participation in a CRAFT program for guardians gives an increased the participant's self-efficacy compared to treatment as usual
6. Participation in a CRAFT program for guardians improves psychological flexibility of the participant compared to treatment as usual
Ethics approval
Regionala etikprövningsnämnden i Stockholm (The Regional Ethical Review Board of Stockholm), 26/09/2018, 2018/1642-31
Study design
Interventional two group block randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Substance use
Intervention
Participants will be randomly allocated to either the intervention or control group through block randomisation in a 1:1 ratio by a researcher not connected to the study.
The intervention group will receive the Community Reinforcement Approach and Family Training (CRAFT), adapted to caregivers of substance using adolescents. This contains 8 sessions delivered over a 10-week period by counsellors at an adolescent substance care unit (Mini Maria).
The control group will receive treatment as usual, which involves 4 counselling sessions together with 1 follow-up session delivered by counsellors at an adolescent substance care unit (Mini Maria) and a group session with the main purpose to enhance participants knowledge about cannabis.
All participants will answer questions about their health-related status and their adolescents' health-related status and substance use at four time points, when they enter the study and 6 weeks, 12 weeks and 24 weeks later.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Adolescents help-seeking behavior as reported by caregivers at baseline, 6, 12 and 24 weeks follow-up. At inclusion and at week 24, the information is provided in the form of an interview. At week 6 and 12, the information is provided in the form of a questionnaire.
Secondary outcome measures
The following are self-reported by caregivers of their own and the adolescent's status at the baseline and at 6, 12 and 24 weeks:
1. Adolescent drug and alcohol consumption, assessed using:
1.1. Timeline Followback (TLFB)
1.2. Alcohol Use Disorders Identification Test (AUDIT)
1.3. Drug Use Disorders Identification Test (AUDIT)
2. Adolescent's mental health, assessed using the Child Behavior Checklist (CBCL)
3. Caregiver's mental health, assessed using the Depression Anxiety Stress Scale (DASS-21
4. Caregiver's relational satisfaction, assessed using the Relationship Happiness Scale
5. Caregiver's quality of life, asessed using:
5.1. EQ-5D
5.2. Satisfaction With Life Scale (SWLS)
6. Caregiver's self-efficacy, assessed using the Parental Self-Efficacy Scale
7. Caregiver's psychological flexibility, assessed using the Acceptance and Action Questionnaire - II (AAQ-II)
Overall trial start date
01/08/2018
Overall trial end date
22/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Guardian/caregiver:
1. Formal or informal caregiver to a substance-using adolescent
2. Living with the adolescent at least 50% of the time per month, with no plan to change this pattern
3. Explicit wish that the adolescent seek formal treatment
4. Living in the Stockholm region
Adolescent of the participating caregiver:
1. Aged 15-19 years
2. Existing problems related to alcohol or drug
3. Would deny formal treatment at study entry according to the caregiver
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
Guardian/caregiver:
1. Fulfill criteria for substance related diagnosis according to DSM-5 (excluding nicotine)
2. Reporting drug use more frequent than one time per month during the last 12 months
3. Prevailing psychological or cognitive problems considered as a barrier in using the program materials, e.g. psychotic conditions
4. Participation in other support programs for significant others to people with drug or alcohol problems currently or during the last three months
Adolescent (according to the caregiver):
1. Prevailing psychological or cognitive problems e.g. psychotic conditions, neuropsychiatric disorders
2. Treatment contact for substance problems during the last 30 days
3. Violent behavior against the guardian during the past year
Recruitment start date
22/10/2018
Recruitment end date
31/03/2020
Locations
Countries of recruitment
Sweden
Trial participating centre
Stockholm Centre for Dependency Disorders, Stockholm County Council
Friskvårdsvägen 4
Stockholm
11281
Sweden
Trial participating centre
Mini Maria Stockholm
Rosenlundsgatan 44B
Stockholm
112 19
Sweden
Sponsor information
Organisation
Stockholm County Council
Sponsor details
Friskvårdsvägen 4
Stockholm
SE-112 81
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Folkhälsomyndigheten
Alternative name(s)
Public Health Agency of Sweden
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Sweden
Results and Publications
Publication and dissemination plan
The study protocol will be published in 2019. The results of the primary outcome will be published as soon as possible after data collection and aggregation, in spring 2021.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available because of GDPR.
Intention to publish date
01/03/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list