Condition category
Mental and Behavioural Disorders
Date applied
07/11/2018
Date assigned
04/03/2019
Last edited
08/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Type

Public

Primary contact

Mr Ola Siljeholm

ORCID ID

Contact details

Riddargatan 1 - Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden

Type

Scientific

Additional contact

Dr Anders Hammarberg

ORCID ID

Contact details

Riddargatan 1
Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden

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

http://beroendecentrum.se/

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

Publication citations

Additional files

Editorial Notes

08/03/2019: Internal review.