Effectiveness of Take it Personal!

August 7, 2023 updated by: Behavioural Science Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6525 GD
        • Recruiting
        • Behavioural Science Institute, Radboud University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
Through study completion, on average 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in daily personal behavioral problem
Time Frame: Through study completion, on average 90 days
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".
Through study completion, on average 90 days
Change in substance use frequency
Time Frame: Baseline, 1-month, 6-month, and 12-months
Measured with SumID-Q survey at baseline, 1-month post-intervention, 6-month post-intervention, and 12-months post-intervention
Baseline, 1-month, 6-month, and 12-months
Experienced changes
Time Frame: 1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Behavioural Science Institute

Collaborators

Pluryn

Investigators

  • Principal Investigator: Evelien Poelen, PhD, Radboud University and Pluryn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 555002014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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