Clinical trial NCT05843474: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use
Drug Use
Mild Intellectual Disability, IQ 50-70
Borderline Intellectual Disabilities (Intelligence Quotient 70-85)
Personality
Adolescent Behavior
Lead sponsor: Behavioural Science Institute
Sponsor class: OTHER
Collaborators: name: Pluryn
First posted: 2023-05-06
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a non-concurrent ABA multiple baseline design
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in daily substance use frequency
timeFrame: Through study completion, on average 90 days
Secondary outcomes:
measure: Change in daily personal behavioral problem
timeFrame: Through study completion, on average 90 days
measure: Change in substance use frequency
timeFrame: Baseline, 1-month, 6-month, and 12-months
measure: Experienced changes
timeFrame: 1 month
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Behavioural Science Institute, Radboud University
Study officials:
affiliation: Radboud University and Pluryn
name: Evelien Poelen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
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.
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.
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
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.
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.