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Effectiveness of Take it Personal!

Primary Purpose

Alcohol Use, Drug Use, Mild Intellectual Disability, IQ 50-70

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Take it Personal!
Sponsored by
Behavioural Science Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: 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 Exclusion criterium - Moderate or severe substance use disorder

Sites / Locations

  • Behavioural Science Institute, Radboud UniversityRecruiting

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

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".
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
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.

Full Information

First Posted
January 16, 2023
Last Updated
August 7, 2023
Sponsor
Behavioural Science Institute
Collaborators
Pluryn
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1. Study Identification

Unique Protocol Identification Number
NCT05843474
Brief Title
Effectiveness of Take it Personal!
Official Title
Effectiveness of Take it Personal! A Substance Use Intervention for Young People With Mild Intellectual Disabilities and Borderline Intellectual Functioning
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Behavioural Science Institute
Collaborators
Pluryn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Drug Use, Mild Intellectual Disability, IQ 50-70, Borderline Intellectual Disabilities (Intelligence Quotient 70-85), Personality, Adolescent Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a non-concurrent ABA multiple baseline design
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Take it Personal!
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in daily substance use frequency
Description
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?"
Time Frame
Through study completion, on average 90 days
Secondary Outcome Measure Information:
Title
Change in daily personal behavioral problem
Description
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".
Time Frame
Through study completion, on average 90 days
Title
Change in substance use frequency
Description
Measured with SumID-Q survey at baseline, 1-month post-intervention, 6-month post-intervention, and 12-months post-intervention
Time Frame
Baseline, 1-month, 6-month, and 12-months
Title
Experienced changes
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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 Exclusion criterium - Moderate or severe substance use disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daan Hulsmans, MSc
Phone
0031648057688
Email
daan.hulsmans@ru.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Evelien Poelen, PhD
Phone
0031631789551
Email
epoelen01@pluryn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelien Poelen, PhD
Organizational Affiliation
Radboud University and Pluryn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioural Science Institute, Radboud University
City
Nijmegen
ZIP/Postal Code
6525 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daan Hulsmans, MSc
Phone
0031648057688
Email
daan.hulsmans@ru.nl
First Name & Middle Initial & Last Name & Degree
Evelien Poelen, PhD
Phone
0031631789551
Email
evelien.poelen@ru.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
Citation
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.
Results Reference
background
Citation
Berman, A. H., Bergman, H., Palmstierna, T., & Schlyter, F. (2003). DUDIT. The drug use identification test manual. Stockholm: Karolinska Institutet, department of clinical neuroscience.
Results Reference
background
PubMed Identifier
19034715
Citation
Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
Results Reference
background
PubMed Identifier
27512590
Citation
Wieland 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.
Results Reference
background
PubMed Identifier
34141398
Citation
Thompson 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.
Results Reference
background
Citation
Zwikker, 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 Reference
background
PubMed Identifier
32990417
Citation
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.
Results Reference
result
PubMed Identifier
32678489
Citation
Schijven 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.
Results Reference
result

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Effectiveness of Take it Personal!

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