Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences

NCT ID: NCT04103541

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-07-01

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.

Conditions

Children Exposed to Adverse Experiences

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IP-Colombia

Group Type: EXPERIMENTAL

IP-Colombia

Intervention Type: BEHAVIORAL

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.

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IP-Colombia

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Wisconsin Madison

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

Psychology,

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0189

Identifier Type: -

Identifier Source: org_study_id