Effectiveness of Take it Personal!

NCT05843474 | Unknown DMC

• 1 other identifier: 555002014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use; Drug Use; Mild Intellectual Disability, IQ 50-70; Borderline Intellectual Disabilities (Intelligence Quotient 70-85); Personality; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• 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?"

  Through study completion, on average 90 days

Secondary Outcomes (3)

• Change in daily personal behavioral problem

  Through study completion, on average 90 days

• Change in substance use frequency

  Baseline, 1-month, 6-month, and 12-months

• Experienced changes

  1 month

Interventions

Take it Personal! BEHAVIORAL

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.

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• \- Moderate or severe substance use disorder

Sponsors & Collaborators

• Behavioural Science Institute: lead
• Pluryn: collaborator

Study Sites (1)

Behavioural Science Institute, Radboud University

Nijmegen, 6525 GD, Netherlands

RECRUITING

Related Publications (8)

• 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.

  BACKGROUND

• Berman, A. H., Bergman, H., Palmstierna, T., & Schlyter, F. (2003). DUDIT. The drug use identification test manual. Stockholm: Karolinska Institutet, department of clinical neuroscience.

  BACKGROUND

• Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.

  PMID: 19034715 BACKGROUND

• 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.

  PMID: 27512590 BACKGROUND

• 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.

  PMID: 34141398 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32990417 RESULT

• 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.

  PMID: 32678489 RESULT

MeSH Terms

Conditions

Alcohol Drinking; Adolescent Behavior

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Evelien Poelen, PhD

  Radboud University and Pluryn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daan Hulsmans, MSc

CONTACT

0031648057688; daan.hulsmans@ru.nl

Evelien Poelen, PhD

CONTACT

0031631789551; epoelen01@pluryn.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a non-concurrent ABA multiple baseline design

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: May 6, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

NL (1)