Evaluation of a support program for caregivers of substance-using adolescents
| ISRCTN | ISRCTN12212515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12212515 |
| Secondary identifying numbers | 2018/1642-31 |
- Submission date
- 07/11/2018
- Registration date
- 04/03/2019
- Last edited
- 25/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Alcohol and drug use among adolescents and young adults 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 helps people resolve their substance use problem. However, adolescents/young adults 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 at caregivers of substance-using adolescents/young adults. Therefore, support programs that target the likelihood of treatment-seeking among adolescents/young adults, as well as the health of the guardians, need to be evaluated. The aim of the study is to investigate the efficacy of CRAFT for caregivers to adolescents/young adults suffering from substance use disorder (SUD), regarding treatment-seeking behaviour and substance use for adolescents/young adults, as well as mental health for caregivers.
Who can participate?
Formal or informal caregivers of adolescents/young adults 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 Community Reinforcement Approach and Family Training (CRAFT), 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 adolescent's/young adult’s 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 difficult situations. 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 November 2021
Who is funding the study?
The Public Health Agency of Sweden (Sweden)
Region Stockholm research funds (ALF)
The KRICA foundation
Who is responsible for the study?
Anders Hammarberg
anders.hammarberg@ki.se
Contact information
Public
Riddargatan 1 - Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden
 ORCID ID |
0000-0002-5829-4764 |
|---|
Scientific
Riddargatan 1
Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden
| ORCID ID |
0000-0002-9976-5227 |
|---|
Study information
| Study design | Interventional two group block randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Community Reinforcement Approach and Family Training (CRAFT) administered to caregivers of substance-using adolescents and young adults: a randomized controlled trial |
| Study acronym | CRAFT |
| Study objectives | 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(s) | Regionala etikprövningsnämnden i Stockholm (The Regional Ethical Review Board of Stockholm), 26/09/2018, 2018/1642-31 |
| Health condition(s) or problem(s) studied | Substance use |
| Intervention | Current interventions as of 06/10/2022: Due to the covid-19 pandemic, the intervention delivery changed from face-to-face at the clinic to video conference after receiving approval for this amendment from the Swedish Ethical Review Authority. 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 for caregivers of substance-using adolescents. This contains 8 sessions delivered over a 10-week period by counsellors via video conference. The control group will receive treatment as usual, which involves 4 counselling sessions together with 1 follow-up session delivered by counsellors via video conference 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. _____ Previous interventions: 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 for 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 |
| 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 study start date | 01/08/2018 |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 |
| Total final enrolment | 113 |
| Key inclusion criteria | Current participant inclusion criteria as of 06/10/2022: Guardian/caregiver/previous caregiver: 1. Formal or informal present or previous caregiver to a substance-using adolescent/young adult 2. Living with, or being in close contact with, the adolescent at least 50% of the time per month, with no plan to change this pattern 3. Explicit wish that the adolescent/young adult seek formal treatment Adolescent/young adult of the participating present/previous caregiver: 1. Aged 15-24 years 2. Existing problems related to alcohol or drug 3. Would deny formal treatment at study entry according to the caregiver _____ Previous 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 |
| Key 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 |
| Date of first enrolment | 22/10/2018 |
| Date of final enrolment | 31/05/2021 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
11281
Sweden
Stockholm
112 19
Sweden
Stockholm
11435
Sweden
Sponsor information
Hospital/treatment centre
Friskvårdsvägen 4
Stockholm
SE-112 81
Sweden
| Website | http://beroendecentrum.se/ |
|---|---|
"ROR" |
https://ror.org/02zrae794 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Public Health Agency of Sweden
- Location
- Sweden
No information available
No information available
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study protocol will be published. The results of the primary outcome will be published as soon as possible after data collection and aggregation. |
| IPD sharing plan | Current IPD sharing statement as of 06/10/2022: The datasets generated and analyzed during the current study will be available upon reasonable request from Ola Siljeholm, ola.siljeholm@regionstockholm.se Data will be available once the results from the primary evaluation of the trial are published in a scientific journal. Scientists interested will contact Siljeholm and make a case for their planned use of the data. Consent from participants to share data with other researchers has not been obtained, but since no identification of participants can occur from the raw data sets we have assessed that the advantages of open data sharing outweigh the potential risks. Requests for using these data will be assessed for any ethical or legal restrictions that may hinder the sharing of data. Requests will have to provide information on such aspects and will be the responsibility of the requesting party. _____ Previous IPD sharing statement: The datasets generated during and/or analysed during the current study are not expected to be made available because of GDPR. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 22/08/2018 | 07/10/2022 | No | No |
| Results article | 30/01/2024 | Yes | No | ||
| Other publications | qualitative results investigating the experiences of CRAFT | 25/06/2024 | 25/06/2024 | Yes | No |
Additional files
Editorial Notes
25/06/2024: Publication reference added.
30/01/2024: Publication reference and total final enrolment added.
07/10/2022: Uploaded protocol (not peer reviewed).
06/10/2022: The following changes have been made and the plain English summary was updated accordingly:
1. The recruitment end date was changed from 31/12/2021 to 31/05/2021.
2. The overall end date was changed from 30/06/2022 to 30/11/2021.
3. The intention to publish date was changed from 01/10/2022 to 01/03/2023.
4. The scientific title was changed from "Community Reinforcement Approach and Family Training (CRAFT) administered to caregivers of substance using adolescents: a randomized controlled trial" to "Community Reinforcement Approach and Family Training (CRAFT) administered to caregivers of substance-using adolescents and young adults: a randomized controlled trial".
5. The participant inclusion criteria have been changed.
6. The interventions have been changed.
7. Region Stockholm Research Funds and The KRICA Foundation have been added as funders.
8. The individual participant data (IPD) sharing statement has been changed.
02/10/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2020 to 31/12/2021.
2. The overall end date was changed from 22/10/2020 to 30/06/2022.
3. The intention to publish date was changed from 01/03/2021 to 01/10/2022.
4. The plain English summary was updated to reflect these changes.
5. The trial participating centre
08/03/2019: Internal review.
