Clinical trial NCT04103541: Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences
Official title: Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Exposed to Adverse Experiences
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 44
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adolescents in the process of reestablishing their rights with the Colombian Family Welfare Institute.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in the level of DNA methylation following IEP-Colombia psychotheraupeutic program
timeFrame: Baseline and after day 8
Secondary outcomes:
measure: Change in Short PTSD Rating Interview (SPRINT) score following IEP-Colombia psychotheraupeutic program
timeFrame: Baseline and after day 8
measure: Change in Mindful Attention and Awareness Scale for Adolescents (MAAS-A) score following IEP-Colombia psychotheraupeutic program
timeFrame: Baseline and after day 8
Other outcomes:
measure: Assessment of Childhood Adverse Experiences (ACEs).
timeFrame: At Baseline
Locations:
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
References: