Alcohol UseNCT05843474
Effectiveness of Take it Personal!
A study testing Take it Personal! in people with Alcohol Use and Drug Use, run by Behavioural Science Institute at 1 site in Netherlands.
Trial summary
A controlled pre-post design study on Take it Personal! has demonstrated effectiveness in reducing the frequency and severity of youth use of alcohol, cannabis or other illicit drugs. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Drug Use, Mild Intellectual Disability, IQ 50-70
- What is being tested?
- Take it Personal!
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between 14 and 30 years of age
- A DSM-5 based diagnosis of mild intellectual disability OR borderline intellectual functioning A mild intellectual disability is characterized by an intelligence quotient (IQ) score between 50-70 and limitations in adaptive behavior that impede a range of everyday social and practical skills. The DSM-5 describes borderline intellectual functioning as a condition in which a person's limited intellectual functioning is the focus of, or has an impact on, their treatment. This diagnosis is typically given when IQ is roughly between 70 and 85. Persons with either diagnosis often lead problematic lives, facing, for example, social and coping difficulties, and are vulnerable to the development of psychopathologies such as substance use disorder.
- Receives specialized in- or outpatient care
- Uses alcohol or drugs at least once per two weeks, as confirmed by participant's clinician
- Owns a mobile phone
Who cannot join
- Moderate or severe substance use disorder
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Behavioural Science Institute, Radboud University
Nijmegen, 6525 GD
Daan Hulsmans, MSc, 0031648057688, daan.hulsmans@ru.nl
Evelien Poelen, PhD, 0031631789551, evelien.poelen@ru.nl
About this study
Official title: Effectiveness of Take it Personal! A Substance Use Intervention for Young People With Mild Intellectual Disabilities and Borderline Intellectual Functioning
A controlled pre-post design study on Take it Personal! has demonstrated effectiveness in reducing the frequency and severity of youth use of alcohol, cannabis or other illicit drugs. Take it Personal! is an existing indicated prevention programme for substance use in youth with a mild intellectual disability or borderline intellectual functioning that addresses each participant's high-risk personality traits for substance abuse. The current Take it Personal! programme is further developed and optimized in collaboration with relevant stakeholders. In particular, the investigators aim to integrate personalized daily diary monitoring in the programme so that trainers can monitor client progresses closely and gain insights into change mechanisms, providing starting points for therapeutic efforts in programme sessions. The investigators conduct a series of case studies with a non-concurrent multiple baseline design to evaluate the effectiveness of Take it Personal!. The baseline lengths are randomly determined, and therefore the start of the intervention is staggered across participants.
Read the detailed description
Procedure Participants have either 14, 17, 20 or 23 days of baseline measurements. After baseline, participants will follow Take it Personal! for six weeks. Lastly, there is a follow-up phase in which each participant completes 30 days of daily diaries.
The Ethica mobile phone application is used for data collection, which facilitates user-friendly editing and adding of items to optimally personalize monitoring and care. Trainer and client can translate intervention goals into the participant's daily diary items. Completing daily diaries primarily has a clinical incentive for participants, as responses are discussed in Take it Personal!. That is, during the programme, data are fed back to the therapists to facilitate deeper knowledge on participant's behavioural and affective patters. In individual sessions, participant and trainer will inspect and interpret the daily monitoring data to gain more structured insights into changes over time.
To gain additional insight into the long-term effects on substance use frequency, problems caused by substance use and symptoms of dependence, the investigators administer the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Use Disorders Identification Test (DUDIT), which are incorporated as subscales in the Substance Use and Misuse among Intellectually Disabled Persons Questionnaire (SumID-Q) and this survey's collateral report version (SumID-CR) to respectively participants and daily carers at baseline, 1-, 6- and 12-month follow-up.
The investigators add complementary qualitative components that will enable better interpretation of why changes occur or not occur for individuals. One month after the last Take it Personal! session, the Client Change Interview (CCI) is administered to the participant and his/her daily carer separately. The CCI is a semi structured interview, previously used in a mild intellectual disability, in which participants reflect on changes they did and did not notice since starting the programme and contemplate on what caused this. During the CCI, participant and the participant's primary carer are asked to reflect on during which periods changes occurred.
Sample size 15 participants
Sample size justification The joint Dutch quality assessment procedure ('erkenningstraject effectieve interventies') states that a series of at least 10 well-executed case studies, under different conditions and different therapists, is recognized to demonstrate strong evidence for intervention and prevention effectiveness. The investigators obtain an additional 30% to account for withdrawal, drop-out, missing data, and decreasing adherence rates, resulting in a required sample size of 15 participants who will enroll in a non-concurrent multiple baseline study with different therapists per group.
- Conditions
- Alcohol Use, Drug Use, Mild Intellectual Disability, IQ 50-70, Borderline Intellectual Disabilities (Intelligence Quotient 70-85), Personality, Adolescent Behavior
- Being tested
- Take it Personal!
- Medical subject headings
- Alcohol Drinking, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take it Personal!Behavioural
Take it Personal! is a six-week indicated prevention program for youth with a mild intellectual disability or borderline intellectual functioning. The program aims to teach youngsters skills to reduce their substance use (alcohol, cannabis, and other drugs). The prevention program differentiates four personality profiles associated with a higher risk for problematic substance use: sensation seeking, impulsivity, anxiety sensitivity and negative thinking. For each of the four personality profiles, different program outlines were developed that are similar in structure but have their own personality-specific materials, games and (psychomotor) exercises. There are weekly individual- and group sessions with three to four participants, led by a clinical psychologist and a psychomotor therapist. Motivational interviewing and cognitive behavioral therapeutic principles are applied, both of which have proven effectiveness in decreasing substance use the target group.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily substance use frequency
Daily diaries include at least one item about substance use. Depending on which substance the individual uses, it will inquire after units of the substance used per day. For example, "how many glasses of alcohol did you drink today?" or "how many joints did you smoke today?"
Measured: Through study completion, on average 90 days
Secondary outcomes (3)
Change in daily personal behavioral problem
Daily diaries will include at least one item about personally relevant issues that the participant wants to work on in Take it Personal! which will be rated on a 5-point Likert scale ranging from "not at all" to "very much".
Measured: Through study completion, on average 90 days
Change in substance use frequency
Measured with SumID-Q survey at baseline, 1-month post-intervention, 6-month post-intervention, and 12-months post-intervention
Measured: Baseline, 1-month, 6-month, and 12-months
Experienced changes
The Client Change Interview that is administered one month post-intervention. The interview maps out which behavioral changes the client noticed since starting Take it Personal!, the importance they had, and to which causes the client attributes these changes. These qualitative results are presented descriptively.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a non-concurrent ABA multiple baseline design
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Behavioural Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pluryn
- Responsible party
- Sponsor
- Investigators
- Evelien Poelen, PhD, Principal investigator, Radboud University and Pluryn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843474
- Sponsor's protocol ID
- 555002014
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Preregistration, metadata and analyses scripts/syntax will be stored in the Open Science Framework (OSF; www.osf.io) and will be made findable and accessible publicly. The raw data (i.e., pseudonymized quantitative data in .csv of daily diaries, standardized surveys and anonymized transcripts of the client change interviews), as well the metadata, will be made findable and openly accessible on the repository of Radboud University: Radboud Repository. A persistent identifier will be made through OSF, which is then also included in the Radboud Repository. Hence, we use only one DOI. Sensitive data cannot be made publicly accessible. Therefore, audio recordings of the interviews nor any contact information (names, e-mail addresses, addresses) are not accessible.
Publications
Babor, T. F., Higgins-Biddle, J. C., Saunders, J. B., & Monteiro, M. G. (2001). AUDIT. The alcohol use disorders identification test. Guidelines for use in primary care. Geneva: World Health Organisation.
Berman, A. H., Bergman, H., Palmstierna, T., & Schlyter, F. (2003). DUDIT. The drug use identification test manual. Stockholm: Karolinska Institutet, department of clinical neuroscience.
Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
PubMed 19034715Wieland J, Zitman FG. It is time to bring borderline intellectual functioning back into the main fold of classification systems. BJPsych Bull. 2016 Aug;40(4):204-6. doi: 10.1192/pb.bp.115.051490.
PubMed 27512590Thompson B, Tickle A, Dillon G. Discovery awareness for staff supporting individuals with intellectual disabilities and challenging behaviour: is it helpful and does it increase self-efficacy? Int J Dev Disabil. 2019 Apr 20;67(1):44-57. doi: 10.1080/20473869.2019.1599605.
PubMed 34141398Zwikker, M., van Dale, D., Dunnink, T., Willemse, G, van Rooijen, S., Heeringa, N., & Rensen, P. (2015). Erkenning van interventies. Criteria voor gezamenlijke kwaliteitsbeoordeling 2015-2018. Trimbos Instituut/Vilans/Movisie/NCJ/NISB/NJi/RIVM
Schijven EP, VanDerNagel JEL, Otten R, Lammers J, Poelen EAP. Take it personal! Development and modelling study of an indicated prevention programme for substance use in adolescents and young adults with mild intellectual disabilities and borderline intellectual functioning. J Appl Res Intellect Disabil. 2021 Jan;34(1):307-315. doi: 10.1111/jar.12808. Epub 2020 Sep 29.
PubMed 32990417Schijven EP, Hulsmans DHG, VanDerNagel JEL, Lammers J, Otten R, Poelen EAP. The effectiveness of an indicated prevention programme for substance use in individuals with mild intellectual disabilities and borderline intellectual functioning: results of a quasi-experimental study. Addiction. 2021 Feb;116(2):373-381. doi: 10.1111/add.15156. Epub 2020 Sep 21.
PubMed 32678489
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Take it Personal! A Substance Use Intervention for Young People With Mild Intellectual Disabilities and Borderline Intellectual Functioning
- ClinicalTrials.gov ID
- NCT05843474
- Acronym / sponsor ID
- 555002014
- Conditions
- Alcohol Use, Drug Use, Mild Intellectual Disability, IQ 50-70, Borderline Intellectual Disabilities (Intelligence Quotient 70-85), Personality, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Behavioural Science InstituteUniversity, hospital or other
- Collaborators
- Pluryn
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A controlled pre-post design study on Take it Personal! has demonstrated effectiveness in reducing the frequency and severity of youth use of alcohol, cannabis or other illicit drugs. Take it Personal! is an existing indicated prevention programme for substance use in youth with a mild intellectual disability or borderline intellectual functioning that addresses each participant's high-risk personality traits for substance abuse. The current Take it Personal! programme is further developed and optimized in collaboration with relevant stakeholders. In particular, the investigators aim to integrate personalized daily diary monitoring in the programme so that trainers can monitor client progresses closely and gain insights into change mechanisms, providing starting points for therapeutic efforts in programme sessions. The investigators conduct a series of case studies with a non-concurrent multiple baseline design to evaluate the effectiveness of Take it Personal!. The baseline lengths are randomly determined, and therefore the start of the intervention is staggered across participants.
Detailed description
Procedure Participants have either 14, 17, 20 or 23 days of baseline measurements. After baseline, participants will follow Take it Personal! for six weeks. Lastly, there is a follow-up phase in which each participant completes 30 days of daily diaries.
The Ethica mobile phone application is used for data collection, which facilitates user-friendly editing and adding of items to optimally personalize monitoring and care. Trainer and client can translate intervention goals into the participant's daily diary items. Completing daily diaries primarily has a clinical incentive for participants, as responses are discussed in Take it Personal!. That is, during the programme, data are fed back to the therapists to facilitate deeper knowledge on participant's behavioural and affective patters. In individual sessions, participant and trainer will inspect and interpret the daily monitoring data to gain more structured insights into changes over time.
To gain additional insight into the long-term effects on substance use frequency, problems caused by substance use and symptoms of dependence, the investigators administer the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Use Disorders Identification Test (DUDIT), which are incorporated as subscales in the Substance Use and Misuse among Intellectually Disabled Persons Questionnaire (SumID-Q) and this survey's collateral report version (SumID-CR) to respectively participants and daily carers at baseline, 1-, 6- and 12-month follow-up.
The investigators add complementary qualitative components that will enable better interpretation of why changes occur or not occur for individuals. One month after the last Take it Personal! session, the Client Change Interview (CCI) is administered to the participant and his/her daily carer separately. The CCI is a semi structured interview, previously used in a mild intellectual disability, in which participants reflect on changes they did and did not notice since starting the programme and contemplate on what caused this. During the CCI, participant and the participant's primary carer are asked to reflect on during which periods changes occurred.
Sample size 15 participants
Sample size justification The joint Dutch quality assessment procedure ('erkenningstraject effectieve interventies') states that a series of at least 10 well-executed case studies, under different conditions and different therapists, is recognized to demonstrate strong evidence for intervention and prevention effectiveness. The investigators obtain an additional 30% to account for withdrawal, drop-out, missing data, and decreasing adherence rates, resulting in a required sample size of 15 participants who will enroll in a non-concurrent multiple baseline study with different therapists per group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- a non-concurrent ABA multiple baseline design
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between 14 and 30 years of age
- A DSM-5 based diagnosis of mild intellectual disability OR borderline intellectual functioning A mild intellectual disability is characterized by an intelligence quotient (IQ) score between 50-70 and limitations in adaptive behavior that impede a range of everyday social and practical skills. The DSM-5 describes borderline intellectual functioning as a condition in which a person's limited intellectual functioning is the focus of, or has an impact on, their treatment. This diagnosis is typically given when IQ is roughly between 70 and 85. Persons with either diagnosis often lead problematic lives, facing, for example, social and coping difficulties, and are vulnerable to the development of psychopathologies such as substance use disorder.
- Receives specialized in- or outpatient care
- Uses alcohol or drugs at least once per two weeks, as confirmed by participant's clinician
- Owns a mobile phone
Key exclusion criteria (1 listed)
- Moderate or severe substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take it Personal!Take it Personal! is a six-week indicated prevention program for youth with a mild intellectual disability or borderline intellectual functioning. The program aims to teach youngsters skills to reduce their substance use (alcohol, cannabis, and other drugs). The prevention program differentiates four personality profiles associated with a higher risk for problematic substance use: sensation seeking, impulsivity, anxiety sensitivity and negative thinking. For each of the four personality profiles, different program outlines were developed that are similar in structure but have their own personality-specific materials, games and (psychomotor) exercises. There are weekly individual- and group sessions with three to four participants, led by a clinical psychologist and a psychomotor therapist. Motivational interviewing and cognitive behavioral therapeutic principles are applied, both of which have proven effectiveness in decreasing substance use the target group. | Behavioural | – |
Primary outcome
Change in daily substance use frequency
Time frame: Through study completion, on average 90 days
Daily diaries include at least one item about substance use. Depending on which substance the individual uses, it will inquire after units of the substance used per day. For example, "how many glasses of alcohol did you drink today?" or "how many joints did you smoke today?"
3 secondary outcomes
Change in daily personal behavioral problem
Time frame: Through study completion, on average 90 days
Change in substance use frequency
Time frame: Baseline, 1-month, 6-month, and 12-months
Experienced changes
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- BackgroundBabor, T. F., Higgins-Biddle, J. C., Saunders, J. B., & Monteiro, M. G. (2001). AUDIT. The alcohol use disorders identification test. Guidelines for use in primary care. Geneva: World Health Organisation.
- BackgroundBerman, A. H., Bergman, H., Palmstierna, T., & Schlyter, F. (2003). DUDIT. The drug use identification test manual. Stockholm: Karolinska Institutet, department of clinical neuroscience.
- Background: PubMed 19034715Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
- Background: PubMed 27512590Wieland J, Zitman FG. It is time to bring borderline intellectual functioning back into the main fold of classification systems. BJPsych Bull. 2016 Aug;40(4):204-6. doi: 10.1192/pb.bp.115.051490.
- Background: PubMed 34141398Thompson B, Tickle A, Dillon G. Discovery awareness for staff supporting individuals with intellectual disabilities and challenging behaviour: is it helpful and does it increase self-efficacy? Int J Dev Disabil. 2019 Apr 20;67(1):44-57. doi: 10.1080/20473869.2019.1599605.
- BackgroundZwikker, M., van Dale, D., Dunnink, T., Willemse, G, van Rooijen, S., Heeringa, N., & Rensen, P. (2015). Erkenning van interventies. Criteria voor gezamenlijke kwaliteitsbeoordeling 2015-2018. Trimbos Instituut/Vilans/Movisie/NCJ/NISB/NJi/RIVM
- Results publication: PubMed 32990417Schijven EP, VanDerNagel JEL, Otten R, Lammers J, Poelen EAP. Take it personal! Development and modelling study of an indicated prevention programme for substance use in adolescents and young adults with mild intellectual disabilities and borderline intellectual functioning. J Appl Res Intellect Disabil. 2021 Jan;34(1):307-315. doi: 10.1111/jar.12808. Epub 2020 Sep 29.
- Results publication: PubMed 32678489Schijven EP, Hulsmans DHG, VanDerNagel JEL, Lammers J, Otten R, Poelen EAP. The effectiveness of an indicated prevention programme for substance use in individuals with mild intellectual disabilities and borderline intellectual functioning: results of a quasi-experimental study. Addiction. 2021 Feb;116(2):373-381. doi: 10.1111/add.15156. Epub 2020 Sep 21.
- Individual participant dataSharing planned: Yes. Preregistration, metadata and analyses scripts/syntax will be stored in the Open Science Framework (OSF; www.osf.io) and will be made findable and accessible publicly. The raw data (i.e., pseudonymized quantitative data in .csv of daily diaries, standardized surveys and anonymized transcripts of the client change interviews), as well the metadata, will be made findable and openly accessible on the repository of Radboud University: Radboud Repository. A persistent identifier will be made through OSF, which is then also included in the Radboud Repository. Hence, we use only one DOI. Sensitive data cannot be made publicly accessible. Therefore, audio recordings of the interviews nor any contact information (names, e-mail addresses, addresses) are not accessible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelien Poelen, PhD principal investigator
Radboud University and Pluryn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take it Personal! in people with Alcohol Use and Drug Use, run by Behavioural Science Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daan Hulsmans, MSc (0031648057688, daan.hulsmans@ru.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily substance use frequency (time frame: Through study completion, on average 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843474, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.