Children Exposed to Adverse ExperiencesNCT04103541
Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences
A study testing IP-Colombia in people with Children Exposed to Adverse Experiences, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Children Exposed to Adverse Experiences
- What is being tested?
- IP-Colombia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents in the process of reestablishing their rights with the Colombian Family Welfare Institute.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Madison
Madison, Wisconsin, 53703
About this study
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.
Read the 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
- Being tested
- IP-Colombia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP-ColombiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IP-Colombia | Experimental | Not described Receives: Behavioral: IP-Colombia |
| Waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of DNA methylation following IEP-Colombia psychotheraupeutic program
Saliva sample from children who were exposed to adverse experience during their childhood, will be examined for DNA methylation levels at roughly half a million sites. This will occur both before and after attending the Individualized Education Program(IEP)-Colombia psychotherapeutic program. Epigenetic modifications, such as DNA methylation, are mechanisms for regulating gene expression that are strongly influenced by environment, experiences, and lifestyle.
Measured: Baseline and after day 8
Secondary outcomes (2)
Change in Short PTSD Rating Interview (SPRINT) score following IEP-Colombia psychotheraupeutic program
SPRINT is an eight-item self-report measure that assesses the core symptoms of PTSD (intrusion, avoidance, numbing, arousal), somatic malaise, stress vulnerability, and role and social functional impairment. The SPRINT does not map onto any specific version of Diagnostic and Statistical Manual of Mental Disorders (DSM) but rather is intended to capture the common symptoms that tend to be reported by people with PTSD when first seeking care. SPRINT is responsive to symptom change over time and can serve as a measure of PTSD illness severity and of global improvement. Symptoms are rated on five-point scales from 0 (not at all) to 4 (very much) and the authors suggest a cutoff score of 14 for this screen. Those receiving positive scores should be further assessed.
Measured: Baseline and after day 8
Change in Mindful Attention and Awareness Scale for Adolescents (MAAS-A) score following IEP-Colombia psychotheraupeutic program
The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The items are answered on a six-point scale (1=Almost always; 6=Almost never) on which higher scores are an indication of higher trait mindfulness.
The scale shows strong psychometric properties and has been validated with college, community, and cancer patient samples. Correlational, quasi-experimental, and laboratory studies have shown that the MAAS taps a unique quality of consciousness that is related to, and predictive of, a variety of self-regulation and well-being constructs. The measure takes 10 minutes or less to complete.
Measured: Baseline and after day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Exposed to Adverse ExperiencesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103541
- Sponsor's protocol ID
- 2019-0189
- Other IDs
- Psychology,
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data received by the Center for Healthy Minds will be coded. These data will be stored on dedicated servers, housed in a data center with access limited to authorized personnel. "Although not fully described in this application, any future research using this study data will remain in line with the original study's objectives and themes." "Specimens will not be returned to the lead site. They will be destroyed after analysis." Hard copies of study materials, such as consent forms and screening logs, will remain at Universidad de Santander, as will the key that links identifiable information to coded data. Access to study data is restricted to lab computers by the use of a network firewall, and further restricted only to users specifically authorized for each study. Access to data is disabled when a user leaves the lab. Periodic audits verify system integrity and security, and account activity.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Impact of a Psychotherapeutic Program in Adolescents With Severe Adverse Experiences
- ClinicalTrials.gov ID
- NCT04103541
- Acronym / sponsor ID
- 2019-0189
- Conditions
- Children Exposed to Adverse Experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP-Colombia | Experimental | Behavioral: IP-Colombia |
| Waitlist control | No intervention | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents in the process of reestablishing their rights with the Colombian Family Welfare Institute.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP-ColombiaThe 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. | Behavioural | IP-Colombia |
Primary outcome
Change in the level of DNA methylation following IEP-Colombia psychotheraupeutic program
Time frame: Baseline and after day 8
Saliva sample from children who were exposed to adverse experience during their childhood, will be examined for DNA methylation levels at roughly half a million sites. This will occur both before and after attending the Individualized Education Program(IEP)-Colombia psychotherapeutic program. Epigenetic modifications, such as DNA methylation, are mechanisms for regulating gene expression that are strongly influenced by environment, experiences, and lifestyle.
2 secondary outcomes
Change in Short PTSD Rating Interview (SPRINT) score following IEP-Colombia psychotheraupeutic program
Time frame: Baseline and after day 8
Change in Mindful Attention and Awareness Scale for Adolescents (MAAS-A) score following IEP-Colombia psychotheraupeutic program
Time frame: Baseline and after day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No. All data received by the Center for Healthy Minds will be coded. These data will be stored on dedicated servers, housed in a data center with access limited to authorized personnel. "Although not fully described in this application, any future research using this study data will remain in line with the original study's objectives and themes." "Specimens will not be returned to the lead site. They will be destroyed after analysis." Hard copies of study materials, such as consent forms and screening logs, will remain at Universidad de Santander, as will the key that links identifiable information to coded data. Access to study data is restricted to lab computers by the use of a network firewall, and further restricted only to users specifically authorized for each study. Access to data is disabled when a user leaves the lab. Periodic audits verify system integrity and security, and account activity.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP-Colombia in people with Children Exposed to Adverse Experiences, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of DNA methylation following IEP-Colombia psychotheraupeutic program (time frame: Baseline and after day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.