Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences
Condition: Children Exposed to Adverse Experiences
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): IP-Colombia
Intervention type(s): Behavioral
Intervention description(s): The IP-Colombia program is a multi-component intervention carried out in the context of therapeutic camp, based on EDMR 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment