Maltreatment, ChildNCT03374969
Differential DNA Methylation as a Function of a Parenting Intervention
A study testing Attachment and Biobehavioral Catch-Up and Developmental Education for Families in people with Maltreatment, Child, run by University of Delaware.
Trial summary
The aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Maltreatment, Child
- What is being tested?
- Attachment and Biobehavioral Catch-Up and Developmental Education for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2013to 10 Feb 2017
- 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 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents will be considered potentially eligible if they have a child between the ages of 6 and 20 months and have a history of substantiated or unsubstantiated report of maltreatment or domestic violence. After obtaining informed consent, observational assessments of sensitivity will be conducted, allowing screening of parents with low levels of sensitivity (who are expected to benefit more from the intervention than others). Only those parents who have scores in the insensitive range will be included in the full study.
Who cannot join
- Children with known serious medical issues (e.g., cerebral palsy) will be excluded from the sample. Also, high-risk parents will be screened for sensitivity to ensure that they will benefit from the intervention. Only those who are screened as relatively insensitive (1-2 on a 5 point coding scale) will be included in the full study.
- If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
- If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.
About this study
Official title: Differential DNA Methylation as a Function of a Parenting Intervention: A Randomized Clinical Trial
The aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health.
Read the detailed description
This study assesses whether a 10-session intervention for maltreating parents effects the epigenome of young children who have experienced early maltreatment. Families are randomly assigned to the experimental condition (Attachment and Biobehavioral Catch-Up) or a treatment control (Developmental Education for Families). Biological samples and behavioral observations of parenting will be collected pre- and post- intervention. Biological samples will be used to conduct whole genome analyses of differential DNA methylation that occur as a result of the intervention. Behavioral observations of parent-child interactions will be used to assess the efficacy of the intervention in altering parenting behaviors.
- Conditions
- Maltreatment, Child
- Being tested
- Attachment and Biobehavioral Catch-Up, Developmental Education for Families
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-UpBehavioural
Attachment and Biobehavioral Catch-up (ABC) is a 10-session, weekly intervention delivered in the family's home. ABC addresses three primary issues. First, young children who have experienced early adversity are especially in need of nurturance and parents who behave in synchronous ways and delight in them. Next, when parents behave in frightening ways, it is difficult for children to look to them for reassurance when distressed. This can be particularly difficult for children who have experienced early adversity. Therefore, this intervention helps parents learn how to: 1) behave in nurturing ways when children are distressed; 2) behave in synchronous, delighted ways when children are not distressed; and 3) avoid behaving in frightening or intrusive ways. Interventionists are provided with a manualized protocol, but tailor specific session content to each family's needs. Sessions are videotaped, both for playback to families, and for supervision.
Developmental Education for FamiliesBehavioural
Developmental Education for Families (DEF) is a 10-session, weekly intervention delivered in the family's home. DEF focuses on enhancing gross and fine motor skills, cognition and language development. The age-based protocols (i.e., 6-24 months,) provide information about the developmental themes of focus for each week and suggest activities to enhance the target skills for that week. However, the protocols do not provide a direct script with which to conduct the sessions. Interventionists tailor the developmental program session to the needs of the child and family by considering the child's current gross, fine, cognitive and language skills and creatively preparing several activities that will address the session topics.
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-Up | Experimental | Not described Receives: Behavioral: Attachment and Biobehavioral Catch-Up |
| Developmental Education for Families | Active comparator | Not described Receives: Behavioral: Developmental Education for Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Genome DNA Methylation
Measured: from date of enrollment to 1 month after completing the intervention
Secondary outcomes (1)
Parental Sensitivity
Measured: On date of enrollment, each intervention session, and 1 month after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start9 Dec 2013
- Primary completion16 Dec 2014
- Study completion10 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maltreatment, ChildStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Dozier, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374969
- Sponsor's protocol ID
- 511457
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential DNA Methylation as a Function of a Parenting Intervention: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03374969
- Acronym / sponsor ID
- 511457
- Conditions
- Maltreatment, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 9 Dec 2013 (actual)
- Primary completion
- 16 Dec 2014 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 15 Dec 2017 (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.
The aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health.
Detailed description
This study assesses whether a 10-session intervention for maltreating parents effects the epigenome of young children who have experienced early maltreatment. Families are randomly assigned to the experimental condition (Attachment and Biobehavioral Catch-Up) or a treatment control (Developmental Education for Families). Biological samples and behavioral observations of parenting will be collected pre- and post- intervention. Biological samples will be used to conduct whole genome analyses of differential DNA methylation that occur as a result of the intervention. Behavioral observations of parent-child interactions will be used to assess the efficacy of the intervention in altering parenting behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attachment and Biobehavioral Catch-Up | Experimental | Behavioral: Attachment and Biobehavioral Catch-Up |
| Developmental Education for Families | Active comparator | Behavioral: Developmental Education for Families |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents will be considered potentially eligible if they have a child between the ages of 6 and 20 months and have a history of substantiated or unsubstantiated report of maltreatment or domestic violence. After obtaining informed consent, observational assessments of sensitivity will be conducted, allowing screening of parents with low levels of sensitivity (who are expected to benefit more from the intervention than others). Only those parents who have scores in the insensitive range will be included in the full study.
Key exclusion criteria (3 listed)
- Children with known serious medical issues (e.g., cerebral palsy) will be excluded from the sample. Also, high-risk parents will be screened for sensitivity to ensure that they will benefit from the intervention. Only those who are screened as relatively insensitive (1-2 on a 5 point coding scale) will be included in the full study.
- If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
- If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.
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 |
|---|---|---|
| Attachment and Biobehavioral Catch-UpAttachment and Biobehavioral Catch-up (ABC) is a 10-session, weekly intervention delivered in the family's home. ABC addresses three primary issues. First, young children who have experienced early adversity are especially in need of nurturance and parents who behave in synchronous ways and delight in them. Next, when parents behave in frightening ways, it is difficult for children to look to them for reassurance when distressed. This can be particularly difficult for children who have experienced early adversity. Therefore, this intervention helps parents learn how to: 1) behave in nurturing ways when children are distressed; 2) behave in synchronous, delighted ways when children are not distressed; and 3) avoid behaving in frightening or intrusive ways. Interventionists are provided with a manualized protocol, but tailor specific session content to each family's needs. Sessions are videotaped, both for playback to families, and for supervision. | Behavioural | Attachment and Biobehavioral Catch-Up |
| Developmental Education for FamiliesDevelopmental Education for Families (DEF) is a 10-session, weekly intervention delivered in the family's home. DEF focuses on enhancing gross and fine motor skills, cognition and language development. The age-based protocols (i.e., 6-24 months,) provide information about the developmental themes of focus for each week and suggest activities to enhance the target skills for that week. However, the protocols do not provide a direct script with which to conduct the sessions. Interventionists tailor the developmental program session to the needs of the child and family by considering the child's current gross, fine, cognitive and language skills and creatively preparing several activities that will address the session topics. | Behavioural | Developmental Education for Families |
Primary outcome
Whole Genome DNA Methylation
Time frame: from date of enrollment to 1 month after completing the intervention
1 secondary outcome
Parental Sensitivity
Time frame: On date of enrollment, each intervention session, and 1 month after completing the intervention
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 19 Dec 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment and Biobehavioral Catch-Up and Developmental Education for Families in people with Maltreatment, Child, run by University of Delaware.
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 3 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Whole Genome DNA Methylation (time frame: from date of enrollment to 1 month after completing the intervention). 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 19 Dec 2017.