A preventive intervention for adolescents with mild to moderate intellectual dissabilities and substance abuse|
|- candidate number||21726|
|- NTR Number||NTR5037|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-feb-2015|
|- Secondary IDs||1402-061 Fonds NutsOhra|
|- Public Title||A preventive intervention for adolescents with mild to moderate intellectual dissabilities and substance abuse|
|- Scientific Title||Evaluating a selective prevention program for substance use and comorbid behavioral problems in adolescents with mild to borderline intellectual disabilities: study protocol of a randomized controlled trial|
|- hypothesis||The main aim of this study is to test the effectiveness of the intervention ‘Take it personal!’ in decreasing substance use by adolescents (age 14 – 21 years old) with mild to borderline ID en behavioral problems who are admitted to treatment facilities in the Netherlands. The effectiveness of the intervention is being assessed by conducting a randomized controlled trail (RCT), with two conditions (treatment and control group). Follow-up assessments will be carried out at two, six and twelve months after the start of the intervention.|
The main hypothesis is that the intervention will result in a reduction of alcohol, cannabis and hard drug use at follow-up in the intervention group compared with the no-intervention control group. We also expect a decrease of the intention to use alcohol, cannabis and/or hard drugs in the future, a change in motives for alcohol and/or drug use after two, six and twelfth moths in the intervention group compared with the control group. In addition, the effect of the program on internalizing and externalizing behavioral problems will be tested after two, six and twelfths months. The hypothesis is that the intervention leads to a decrease of internalizing and externalizing behavioral problems in the intervention group compared with the control group.
|- Healt Condition(s) or Problem(s) studied||Substance abuse, Intellectual disabillities|
|- Inclusion criteria||(1) life time prevalence of alcohol, cannabis or hard drug use,|
(2) belonging to one of the four personality high-risk groups (SS, IMP, AS or NT) and
(3) informed consent of the adolescents and their parents or legal representative.
|- Exclusion criteria||Addiction|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||1-sep-2017|
|- Target number of participants||140|
|- Interventions||Adolescents in the intervention group receive the intervention ‘Take it personal!’ and ‘care as usual’. Adolescents will participate in one of the four versions of the intervention that address each high-risk personality trait. ‘Take it personal!’ comprises of three main components: (1) psycho-education, (2) behavioral coping skills, and (3) cognitive coping skills. In the first phase, the intervention focuses on psycho-education about the participants’ personality profile and the coherent problematic coping behavior, like substance abuse or aggression. In this phase, participants are motivated to become familiar with their personality profile and learn to deal with their personality through exercises. Daily life experiences and coherent physical, cognitive, and behavioral reactions will be analyzed. Participants will set individual goals, which they will try to achieve during the training. The coping skills training will engage adolescents in activities to recognize automatic thoughts. Participants will identify personality-specific thoughts that lead to problematic behavior. For example, the intervention aimed at adolescents with the personality profile ‘Impulsive’ will focus on thinking before taking action. Simultaneously, the participants will be trained to use cognitive restructuring techniques to counter such thoughts. Participants edit a personalized ‘changing plan’ to deal differently with their problematic and risky behavior. |
‘Take it personal!’ is a group intervention and groups will consist of a maximum of four adolescents and a minimum of three. The intervention will involve five group sessions and six individual sessions spread across six weeks. Every week there is one individual and one group session, except for week 5 there is only one individual session. This week is used to give participants extra time to practice with their homework assignment in their daily lives. Individual sessions will last 30 minutes and group sessions will last 45 minutes. During individual sessions, the trainer and participant will prepare that week’s group session. During the individual sessions, the participants will be able to bring a confidant, who they can pick themselves from their team of supervisors. This will increase the generalization to everyday life and ensures that participants feel prepared and secure during the group sessions.
The intervention will be provided by two qualified trainers, one psycho motor therapist and a behavioral scientist. A psycho motor therapist is needed because of the exercises based on these principles and a behavioral scientist because of the principles of CBT and MI. It is desirable that the training is provided by a behavioral scientist who is experienced with these techniques. All trainers will receive a two-day training. In this training, trainers will learn about the principles of CBT and MI and all sessions are practiced. All group sessions are carried out in the psycho motor hall of the home institution. Individual sessions can be held in flexible rooms.
Each individual and group session do have the same structure. Each individual session starts by telling the participant’s confidant what he or she has learned in the last group session and what exercises they have done. After that, the trainer and participant will do some exercises and assignments. In the individual session participants are asked to give examples from their daily lives. These examples are used to do exercises with in the group sessions. Participant’s confidants play a supporting role in the individual session. After that, the participant and trainer are preparing the next group session. All group sessions start by having some drinks and make participants feel at ease and secure. Then there are exercises, games and psycho motor practices with prepared material from the individual sessions. Every group session consists at least out of one exercise from psycho motor therapy. To close the group sessions, the trainers and participants will summarize that group session together. The training is developed according to the principles of CBT and adjusted to the cognitive capacities of adolescents with mild to borderline ID.
Adolescents assigned to the control group will receive no further intervention, but will receive ‘care as usual’. ‘Care as usual’ will not be standardized or protocollized, but we will make an inventory of other prevention and interventions aimed at substance use. Most adolescents receive treatment for their own specific problems; some of them receive residential care, others receive extramural treatment. In both cases, treatment is formulated through personal goals in a so called ‘individual treatment plan’. A multidisciplinary team is involved in the treatment program of each adolescent. All participating adolescents will be rewarded with a small gift.
|- Primary outcome||‘Take it Personal!’ aims to decrease substance use by adolescents with mild and borderline ID. We operationalized goals for alcohol, cannabis and hard drug use. The primary outcome for alcohol use are the percentage of decrease in binge drinking, weakly use and problematic use. The primary outcomes for cannabis use are the percentage of decrease in lifetime cannabis use and weakly use. The primary outcome for hard drug use is the percentage of decrease in lifetime use. |
|- Secondary outcome||Secondary outcomes are the intention to use less alcohol and/or drugs in the future (Malmberg 2010], motives for alcohol and/or drug use (Drinking Motives Questionaire-Revised-Short Form (DMQ-R-SF) and internalizing and externalizing behavioural problems measured by YSR.|
|- Timepoints||There wil be a pre-test before the intervention starts and there will be post-tests 2, 6 and 12 months after start of the intervention.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Esmee Schijven|
|- CONTACT for SCIENTIFIC QUERIES|| Evelien Poelen|
|- Sponsor/Initiator ||Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|Fonds Nuts-Ohra, Pluryn|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||26-feb-2015 - 15-apr-2015|
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