Children Exposed to Adverse Experiences Clinical Trial
Official title:
Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences
In this project, the investigator proposes to examine the influence of a psychotherapeutic program, designed for adolescents with a history of early adverse environmental and psychosocial experiences, on gene expression in order to find ways to reverse critical molecular mechanisms that associate extreme childhood stress with the development of a series of health problems, with important repercussions at both the individual and social levels.
The investigator proposes a randomized controlled clinical trial to be attended by
adolescents who are in the process of re-establishing their rights with the Colombian Family
Welfare Institute. The study team will compare the genome methylation states of saliva
samples from a group of 21 adolescents (children, ages 13 to 16), [both] before and after an
8-day residential intervention (IP-Colombia psychotherapeutic program). A randomized control
group (waitlist) (n=21) will be included, from which baseline samples and samples after 8
days in their usual living conditions will be collected. For randomization, the evaluation of
exposure to stress during childhood will be measured by using a questionnaire on adverse
experiences.
The IP-Colombia program is a multi-component intervention carried out in the context of
therapeutic camp, based on Eye Movement Desensitization and Reprocessing (EMDR) therapies and
mindfulness-based interventions. Alongside the interventions, activities are done to
facilitate healthy lifestyles, empathy, [and] the recognition and expression of emotions
through exercise, art workshops, musical creation, dance and theater. Previous studies
carried out by the Colombia Innocence in Danger Foundation have shown the significant effects
of the IP-Colombia protocol in the treatment of children with post-traumatic stress disorder
associated with severe interpersonal violence. The Colombia Innocence in Danger Foundation
team, which has 10 years of experience with this intervention that has benefited around 380
boys, girls, and teenagers, will be responsible for this intervention.
The molecular analysis will be coordinated by Dr. Perla Kaliman, a collaborating researcher
at the Center for Healthy Minds at the University of Wisconsin-Madison, directed by Dr.
Richard Davidson. Dr. Kaliman, in collaboration with Dr. Davidson, has conducted the first
studies showing the epigenetic effects of stress-reduction interventions. The DNA processing
and methylome analysis will be carried out at the University of Wisconsin-Madison, in Dr.
Reid Alisch's laboratory [by] a team recognized worldwide for its experience in the
epigenetics of adverse experiences in young people.
The saliva samples will be collected in duplicate, using Oragene kits for DNA methylation
analysis (DNA Genotek, Canada). The samples will be sent immediately after collection at room
temperature to the Center for Healthy Minds (Madison, Wisconsin).
The DNA will be extracted using the Qiagen kit for human saliva samples, following the
manufacturer's protocol. The genomic DNA samples will be analyzed in a 1% agarose gel, to
verify that the DNA is of high molecular weight, and they will be quantified using Qubit
(Qiagen, USA). DNA methylation levels will be determined using the HumanMethylation450
(Illumina) and the beta values will be obtained using the R min package. Methylation data
that correspond to the methylation in a Single nucleotide polymorphism (SNP) will be
eliminated from the analysis if they contain a SNP within the probe, if they are known to
cross-react, or if a sample has a detection P-value > 0.01.
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