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Measuring the impact of psychological therapy – an experimental approach
Initial registration date
April 29, 2020
April 29, 2020 11:35 AM EDT
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Paris School of Economics
Other Primary Investigator(s)
Additional Trial Information
Throughout the world, a large number of children are growing up or have grown up in families with alcohol and/or drug problems with far reaching consequences on children's current and future life, including anxiety, depression, self-destructive behaviors (e.g. attempted suicide or drug addiction), etc. In Denmark, a country of 5.8 million inhabitants, the extent of the problem is such that 632,000 individuals are growing up or have grown up in families with alcohol problems.
Despite the large prevalence of the problem and its dramatic consequences, there is still little robust evidence showing the causal impact of programs designed to help individuals growing up or who have grown up in such an environment. As a consequence, there is little evidence of any potentially harmful consequences of the substantial waiting time individuals can face before they can benefit from the intervention. Finally, there is also limited robust evidence of any indirect effects these interventions may have on the beneficiaries’ family members which, in turn, may lead to a potentially large underestimation of these interventions’ true impact.
As part of this research project, we propose to provide new evidence of these questions through the evaluation of a therapy-based intervention specifically designed to help individuals who have grown up in a family with an alcohol or drug problem. The intervention is implemented by the non-profit organization TUBA and is evaluated using a randomized controlled trial following a rotation design. We will measure the impact of the intervention on individuals’ psychological health, behavioral problems, and labor market attachment. Registration Citation
We evaluate the impact of a therapy-based intervention specifically designed to help individuals who have grown up in a family with an alcohol or drug problem. The intervention is implemented by the non-profit organization TUBA (Therapy & Counselling for young people, who are Children of Alcohol and Drug abusers). TUBA has 25 centers, scattered all over Denmark, and works with 185 licensed therapists. The intervention takes the form of individual counselling and therapy.
Intervention Start Date
Intervention End Date
Primary Outcomes (end points)
Respondents' psychological health.
Primary Outcomes (explanation)
To measure the impact of the intervention on respondents' psychological health, we will collect survey data and use the following instruments: WHO Well-Being Index (WHO-5), Major Depression Inventory (MDI), Clinical Outcomes in Routine Evaluation (CORE-10), and International Trauma Questionnaire (ITQ).
Secondary Outcomes (end points)
1) Respondents' behaviors and labor market attachment
2) Respondents' family members (children and partner):
- Partners’ behaviors and labor market attachment
- Children’s behaviors and educational outcomes
Secondary Outcomes (explanation)
To measure the impact of the interventions on behaviors, we will use a mix of survey and administrative data on their alcohol and drug consumption, police charges, convictions, etc.
To measure the impact of the intervention on labor market attachment, we will use administrative data on their employment status, earnings, social benefits received, etc.
To measure the impact of the intervention on educational outcomes, we will use administrative data on grade repetitions, school absences, and results at national tests.
1. Study populations
1.a. Inclusion criteria
We will measure the impact of the intervention on individuals aged between 25 and 35 who were raised in an environment characterized by alcohol or drug abuse problems. Nevertheless, for ethical- and implementation-related reasons, will be excluded from the study population individuals meeting any of the following criteria: - Individuals who do not consent to participate in the study
- Individuals who are unable to wait one year to receive treatment
- Individuals who are not looking for a full course of therapy but rather a few counselling sessions
- Individuals who are found not to have sufficient psychological strain or functional impairment to be in need of treatment
- Individuals who have alcohol or drug consumption usage that is so problematic that they cannot benefit from therapeutic treatment until they have received help to reduce their substance abuse
- Individuals who take so much medicine that they cannot benefit from therapeutic counselling
- Individuals who are currently psychotic
TUBA estimates the share of clients meeting at least one of these criteria to be around 10%.
For both logistical and statistical reasons, the study will only be implemented in TUBA’s four largest centers (Aalborg, Aarhus, Copenhagen and Odense), which together represent 56% of TUBA’s clients.
Finally, while the current waiting time to benefit from this intervention exceeds a year in these four centers, it is important to note that for ethical reasons, we will only include in the study sample eligible individuals with an anticipated waiting time over a year (more on this below). 1.b. Selection process
All applicants will be screened following registration by TUBA’s therapists who will decide: - whether or not they are eligible to benefit from the intervention
- whether or not they can be included in our study sample
While all eligible individuals meeting all our inclusion criteria will be included in the study population, the others may be eligible to receive treatment outside the project framework.
2. Trial design Upon registration, eligible individuals will be randomly allocated to either a treatment or a control group in order to guarantee the comparability of the two groups prior to the intervention roll-out. For both financial and logistical reasons, the interventions will be rolled out progressively over a period of 9 months. Four batches of eligible participants will be constituted on the basis of “first-come, first-enrolled in the study.” The first batch will be constituted of all eligible individuals currently on the waiting list with an anticipated waiting time over a year. Subsequent batches will be constituted of all eligible individuals who will have registered to benefit from TUBA’s intervention within a 3-month period (and with an anticipated waiting time over a year). It is estimated that the first batch will be constituted of around 150 individuals and that the subsequent ones will be constituted of around 70 individuals each.
As it is not possible for TUBA to deny eligible individuals treatment for an indefinite period of time, the RCT will follow a rotation design, according to which only the treatment start date will vary across individuals at random. While individuals in the treatment groups will immediately benefit from the intervention, those in the control groups will have to wait for a year.
Importantly, the workload arising from the implementation of the intervention will be shared by all therapists in the four study sites. In turn, this will ensure that the study results are representative of TUBA’s work and not merely of a few therapists.
Experimental Design Details
Randomization will be done in office by a computer.
The draw will be stratified by batch and treatment site.
Was the treatment clustered?
Sample size: planned number of clusters
The intervention will be implemented in TUBA's centers located in the Denmark's four largest cities: Copenhagen, Odense, Aalborg, and Aarhus. In each center, four batches of respondents will be constituted.
Sample size: planned number of observations
Sample size (or number of clusters) by treatment arms
Control group: 180 individuals.
Treatment group: 180 individuals.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
INSTITUTIONAL REVIEW BOARDS (IRBs)
Institutional Review Board at Aarhus University
IRB Approval Date
IRB Approval Number