DepressionSNAPNCT02667522
Shaping Neural Activity Through Parenting
A study testing Parent Child Interaction Therapy (PCIT) in people with Depression and Anxiety, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors, using a parenting intervention. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Parent Child Interaction Therapy (PCIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is 6-7 years old
- Maternal history of anxiety or depression
- Maternal self-report of low positive/high harsh parenting
Who cannot join
- Child has developmental disorder
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Aline Szenczy, BS
About this study
Official title: Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention
The purpose of this study is to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors, using a parenting intervention.
Read the detailed description
Depression and anxiety are among the most frequently diagnosed psychological disorders, with persistent patterns of impairment evident from childhood through adulthood. Impaired functioning of core brain systems that respond to reward and errors may increase risk for depression and anxiety. Importantly, these neural risk markers for depression and anxiety appear to be shaped, at least in part, by environmental input. Problematic parenting is a key environmental factor involved in the intergenerational transmission of depression and anxiety. Low positive parenting is associated with blunted brain responses to reward and harsh parenting is associated with heightened brain responses to errors. This study uses an evidence-based parenting program to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors. Participants will include 80 6- to 7-year-old children and their mothers who will be randomly assigned to participate in a parenting program (Parent Child Interaction Therapy: PCIT) or to a waitlist control group, and brain responses to rewards and errors will be assessed pre- and post-intervention.
- Conditions
- Depression, Anxiety
- Being tested
- Parent Child Interaction Therapy (PCIT)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Child Interaction Therapy (PCIT)Behavioural
PCIT includes 12-16 sessions across two phases: the first focused on enhancing positive parenting during child-directed interactions, and the second focused on reducing harsh parenting during parent-directed interactions. Parents receive feedback and coaching on their interactions with the child during sessions.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Intervention | Experimental | Parenting Intervention: Parent-Child Interaction Therapy (PCIT) Receives: Behavioral: Parent Child Interaction Therapy (PCIT) |
| Waitlist Control | No intervention | Waitlist Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Related Potentials (ERP)
ERP responses to reward (i.e., feedback negativity) and errors (i.e., error-related negativity)
Measured: On average, 1 month after intervention
Secondary outcomes (5)
Parenting quality
Observational assessments of positive and harsh parenting
Measured: On average, 1 month after intervention
Child anxiety symptoms
Parent Questionnaire
Measured: On average, 1 month after intervention
Child depressive symptoms
Parent Questionnaire
Measured: On average, 1 month after intervention
Child anxiety
Structured diagnostic interview
Measured: On average, 1 month after intervention
Child depression
Structured diagnostic interview
Measured: On average, 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Bernard, Stony Brook University
- Investigators
- Kristin Bernard, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667522
- Sponsor's protocol ID
- R21MH108766-01A1
- Acronym
- SNAP
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention
- ClinicalTrials.gov ID
- NCT02667522
- Acronym / sponsor ID
- SNAP / R21MH108766-01A1
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- 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 purpose of this study is to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors, using a parenting intervention.
Detailed description
Depression and anxiety are among the most frequently diagnosed psychological disorders, with persistent patterns of impairment evident from childhood through adulthood. Impaired functioning of core brain systems that respond to reward and errors may increase risk for depression and anxiety. Importantly, these neural risk markers for depression and anxiety appear to be shaped, at least in part, by environmental input. Problematic parenting is a key environmental factor involved in the intergenerational transmission of depression and anxiety. Low positive parenting is associated with blunted brain responses to reward and harsh parenting is associated with heightened brain responses to errors. This study uses an evidence-based parenting program to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors. Participants will include 80 6- to 7-year-old children and their mothers who will be randomly assigned to participate in a parenting program (Parent Child Interaction Therapy: PCIT) or to a waitlist control group, and brain responses to rewards and errors will be assessed pre- and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Intervention | Experimental | Behavioral: Parent Child Interaction Therapy (PCIT)Parenting Intervention: Parent-Child Interaction Therapy (PCIT) |
| Waitlist Control | No intervention | –Waitlist Control Condition |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child is 6-7 years old
- Maternal history of anxiety or depression
- Maternal self-report of low positive/high harsh parenting
Key exclusion criteria (1 listed)
- Child has developmental disorder
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 |
|---|---|---|
| Parent Child Interaction Therapy (PCIT)PCIT includes 12-16 sessions across two phases: the first focused on enhancing positive parenting during child-directed interactions, and the second focused on reducing harsh parenting during parent-directed interactions. Parents receive feedback and coaching on their interactions with the child during sessions. | Behavioural | Parenting Intervention |
Primary outcome
Event-Related Potentials (ERP)
Time frame: On average, 1 month after intervention
ERP responses to reward (i.e., feedback negativity) and errors (i.e., error-related negativity)
5 secondary outcomes
Parenting quality
Time frame: On average, 1 month after intervention
Child anxiety symptoms
Time frame: On average, 1 month after intervention
Child depressive symptoms
Time frame: On average, 1 month after intervention
Child anxiety
Time frame: On average, 1 month after intervention
Child depression
Time frame: On average, 1 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
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.
Kristin Bernard principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Child Interaction Therapy (PCIT) in people with Depression and Anxiety, run by Stony Brook University 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 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristin Bernard (6316327576, kristin.bernard@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Related Potentials (ERP) (time frame: On average, 1 month after 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 18 Apr 2018.