[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659987":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":98,"studyPopulation":88,"armGroups":99,"interventions":117,"overallOfficials":88,"centralContacts":131,"locations":137,"responsibleParty":154,"collaborators":158,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":88,"eligibilityCriteria":168,"healthyVolunteers":169,"sex":170,"minAge":171,"maxAge":88,"enrollmentInfo":172,"targetDuration":88,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":189,"overallStatus":139,"whyStopped":88,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"University of Connecticut","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":50,"otherOutcomes":88},[9,13,17,21,24,28,31,34,37,41,44,47],{"measure":10,"description":11,"timeFrame":12},"Recruitment rate","Number of eligible participants completing baseline assessment divided by months of active recruitment. Will also report the total number of participants randomized.","At completion of active recruitment, approximately 12 months after recruitment begins.",{"measure":14,"description":15,"timeFrame":16},"Retention rate","Percentage of all randomized participants completing the second assessment (T2) within the assessment window. The prior benchmark is at least 80%. The assessment window and completion rule require confirmation.","Second assessment (T2), approximately 7 weeks after the baseline assessment.",{"measure":18,"description":19,"timeFrame":20},"Depressive symptoms","Using the 7-item subscale of the DASS-21 (Depression, Anxiety and Stress Scale - Short Form). Each item is rated on a 0-3 scale (raw score range: 0 - 21). Raw scores are multiplied by 2 to calculate a score that can be interpreted for severity. Higher scores indicate greater depressive symptoms. Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+.","From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).",{"measure":22,"description":23,"timeFrame":20},"Anxiety symptoms","Using the 7-item subscale of the DASS-21 (Depression, Anxiety and Stress Scale - Short Form). Each item is rated on a 0-3 scale (raw score range: 0 - 21). Raw scores are multiplied by 2 to calculate a score that can be interpreted for severity. Higher scores indicate greater depressive symptoms. Anxiety: Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+.",{"measure":25,"description":26,"timeFrame":27},"Stress symptoms","Stress symptoms will be measured using the seven-item Stress subscale of the Depression Anxiety Stress Scales, 21-item version (DASS-21). Each item is rated from 0 to 3, giving a raw subscale score of 0-21. The raw score is multiplied by 2, yielding a reported score of 0-42. Higher scores indicate more severe stress symptoms, a worse outcome. Conventional severity ranges for the multiplied score are normal (0-14), mild (15-18), moderate (19-25), severe (26-33), and extremely severe (34-42).","From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3)",{"measure":29,"description":30,"timeFrame":20},"Child Mental Health","Parents rate their child's emotional and behavioral problems using the Achenbach System of Empirically Based Assessment Brief Problem Monitor Parent Form (BPM-P) for ages 6-18. The 19 items cover internalizing, attention, and externalizing problems. Each is rated 0 (not true), 1 (somewhat true), or 2 (very true). The Total Problems raw score ranges from 0 to 38; higher scores indicate more problems.",{"measure":32,"description":33,"timeFrame":20},"Mindful parenting","Using the 10-item Interpersonal Mindfulness in Parenting Scale to assess parents' attention, awareness, acceptance, and regulation during interactions with their children. Items are rated from 1 (never true) to 5 (always true). After reverse-scoring items where appropriate, the summed score ranges from 10 to 50; higher scores indicate greater mindful parenting.",{"measure":35,"description":36,"timeFrame":20},"Parenting Acceptance and Rejection","Using the combined Acceptance\u002FRejection score from the parent-report Child Report of Parenting Behavior Inventory (CRPBI). Parents rate 16 acceptance items and 16 rejection items from 1 (almost never or never) to 5 (almost always or always). Rejection items are reverse-scored, and all 32 items are averaged for a score ranging from 1 to 5. Higher scores indicate greater acceptance and less rejection of the child.",{"measure":38,"description":39,"timeFrame":40},"Acceptability of Healing Hearts intervention","Participants rate four statements about Healing Hearts using the Acceptability of Intervention Measure (AIM). Each item is scored from 1 (Strongly Disagree) to 5 (Strongly Agree). The four item scores are averaged, yielding a score from 1 to 5. Higher scores indicate greater perceived acceptability.","T2 (approximately 7 weeks after baseline) or T3 (approximately 14 weeks after baseline)",{"measure":42,"description":43,"timeFrame":40},"Appropriateness of Healing Hearts Intervention","Participants rate four statements about the appropriateness of Healing Hearts Intervention with Intervention Appropriateness Measure (IAM). Each item is scored from 1 (Strongly Disagree) to 5 (Strongly Agree). Item scores are averaged to produce a score from 1 to 5; higher scores indicate greater perceived appropriateness.",{"measure":45,"description":46,"timeFrame":40},"Usability of Healing Hearts Intervention","Participants rate 10 statements about the usability of Healing Hearts on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Responses are scored using the standard System Usability Scale (SUS) procedure, including adjustment of negatively worded items, to produce a total score from 0 to 100. Higher scores indicate greater perceived usability.",{"measure":48,"description":49,"timeFrame":27},"Parenting stress","Parenting stress will be measured using the Parenting Stress Index (PSI) short form. Each item is rated from 1 to 5. A total of 36 items are divided into three domains (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child). Higher scores indicate higher parenting stress.",[51,54,57,60,63,67,70,74,78,81,84],{"measure":52,"description":53,"timeFrame":20},"Parental mindful self-regulation","Mindful self-regulation will be measured using the 10-item Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Each item is rated from 1 (\"rarely\u002Fnot at all\") to 4 (\"almost always\"). After reverse-scoring the applicable item, responses are summed to yield a total score from 10 to 40. Higher scores indicate greater dispositional mindfulness, a better outcome.",{"measure":55,"description":56,"timeFrame":20},"Parental executive functioning","Executive functioning will be assessed using the 27-item Executive Function Index (EFI). Items are rated from 1 to 5. After reverse-scoring negatively worded items, responses are summed for a total score ranging from 27 to 135; higher scores indicate better executive functioning.",{"measure":58,"description":59,"timeFrame":20},"Emotion coaching","Using the 14-item Maternal Emotional Style Questionnaire (MESQ). Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Items are summed for a score ranging from 7 to 35. Higher scores indicate greater endorsement of an emotion-coaching parenting style.",{"measure":61,"description":62,"timeFrame":20},"Child prosocial behavior","Using the 5-item Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire (SDQ). Each item is rated on a 3-point scale from 0 (Not True) to 2 (Certainly True). The five items are summed to produce a score ranging from 0 to 10. Higher scores indicate greater prosocial behavior.",{"measure":64,"description":65,"timeFrame":66},"Coparenting Conflict","Parents report conflict with their ex-partner during the past two weeks using 13 items adapted for parent report Children's Perception of Interparental Conflict Scale (CPICS): six assessing conflict frequency and seven assessing conflict intensity. Responses are \"False,\" \"Sort of True,\" or \"True.\" Items are coded and reverse coded as appropriate, then combined into an overall score ranging from 13 to 39. Higher scores indicate greater parent reported interparental conflict. \"Not applicable\" and \"Prefer not to say\" are treated as missing responses.","T1 (baseline)",{"measure":68,"description":69,"timeFrame":20},"Coparenting communication","Parents complete a six-item questionnaire about their emotional responses before and after communicating with their ex-partner. The questions are developed for this study. Each item is rated from 1 (Strongly Disagree) to 5 (Strongly Agree). The two items describing not taking interactions personally and feeling confident are reverse scored. Item scores are averaged to produce a score from 1 to 5; higher scores indicate greater emotional distress related to communication with the ex-partner.",{"measure":71,"description":72,"timeFrame":73},"Effective Discipline (Laxness)","Parents rate 16 statements adapted from the Laxness domain of the Parenting Scale (Arnold et al., 1993), referring to the past two weeks. Each statement is rated from 1 (Strongly Disagree) to 7 (Strongly Agree). Items describing consistent limit setting are reverse scored, and the item scores are averaged to produce a score from 1 to 7. Higher scores indicate more lax or inconsistent discipline.","Baseline (T1), approximately 7 weeks after baseline (T2), and approximately 14 weeks after baseline (T3)",{"measure":75,"description":76,"timeFrame":77},"Effective Discipline (Overreaction)","Parents rate 17 statements adapted from the Overreactivity domain of the Parenting Scale (Arnold et al., 1993), referring to the past two weeks. Each statement is rated from 1 (Strongly Disagree) to 7 (Strongly Agree). Items describing calm responses are reverse scored, and the item scores are averaged to produce a score from 1 to 7. Higher scores indicate more reactive discipline. The physical punishment item is excluded.","Baseline (T1), approximately 7 weeks after baseline (T2), and approximately 14 weeks after baseline (T3).",{"measure":79,"description":80,"timeFrame":20},"Parental emotion socialization","Using a shortened version of the Coping with Children's Negative Emotions Scale (CCNES), parents rate how likely they would be to respond in six ways across 12 situations in which their child experiences a negative emotion. Each response is rated from 1 (very unlikely) to 7 (very likely). Higher scores indicate a greater likelihood of the reaction named by that subscale. Items worded in the opposite direction are reverse-scored according to the instrument's scoring key.",{"measure":82,"description":83,"timeFrame":20},"Dispositional Mindfulness","Participants complete the 39-item Five Facet Mindfulness Questionnaire (FFMQ), which assesses observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Items are rated from 1 (Never or Very Rarely True) to 5 (Very Often or Always True). Specified items are reverse scored, then the 39 item scores are averaged to produce a mean score from 1 to 5. Higher scores indicate greater self-reported dispositional mindfulness.",{"measure":85,"description":86,"timeFrame":87},"Parental executive function (computer-based)","Three E-prime go tasks will be administered to participants who have access to PC. These tasks will be installed on their computer and assess their response accuracy and reaction time. The tasks are: Wisconsin Card Sorting, Counting Backwards, and Stroop. Higher accuracy and faster reaction time within accurate trials indicate better executive functions.","At 7 weeks post-baseline (T2) and 14 weeks post-baseline (T3).",null,{"allocation":90,"interventionModel":91,"interventionModelDescription":88,"primaryPurpose":92,"observationalModel":88,"timePerspective":88,"maskingInfo":93},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":94,"maskingDescription":95,"whoMasked":96},"SINGLE","Participants and intervention-implementation personnel will know the assigned intervention. Primary outcomes are collected through participant-completed questionnaires. A data analyst will receive a dataset with intervention conditions labeled using numeric codes, without program identities or intervention-specific variables that reveal assignment. The code key will be retained by a separate research team member and disclosed after the prespecified analyses are completed and documented.",[97],"OUTCOMES_ASSESSOR","This pilot trial aims to evaluate the feasibility, acceptability and preliminary efficacy of a digital mindfulness app developed through prior formative work and user testing for parents navigating divorce or separation who report elevated psychological distress. Eligible parents complete electronic consent, an intake and identity-verification call, and a baseline survey (T1) before individual randomization in a 1:1:1 ratio. The three arms are: Healing Hearts immediately followed by the parenting program, the parenting program alone, or a set of online educational resources.\n\n1. The Healing Hearts program comprises four Parts with five days of activities per Part. Parents are encouraged to complete one Part weekly. Activities include guided meditation, lessons, journaling and reflection. In the combined arm, electronic New Beginnings Program access follows completion of the midpoint assessment (T2).\n2. The eNBP-only arm receives the parenting program after baseline and retains access during follow-up.\n3. The internet resources arm receives a list of online resources relevant to parenting and family wellbeing.\n\nIntent-to-treat analyses will be used. Follow-up assessments are requested irrespective of intervention completion, subject to participant consent and approved safety procedures.\n\nThe study will estimate recruitment, retention, engagement, usability, acceptability, appropriateness and burden, together with preliminary between-group differences in parent self-regulation, parenting, distress and parent-reported child problems. In addition to online surveys, participants who have access to a PC computer will complete optional PC-based behavioral tasks to assess cognitive functioning.\n\nThe pilot sample is intended to inform a larger trial and is not a formal efficacy evaluation.",[100,107,112],{"label":101,"type":102,"description":103,"interventionNames":104},"Healing Hearts and electronic New Beginnings Program","EXPERIMENTAL","Participants receive the Healing Hearts program (HH) followed by the electronic New Beginnings Program (eNBP). The two interventions are received sequentially. HH is first offered after baseline randomization as a self-guided mindfulness app that contains four Parts, which contain five days of activities each (i.e., a total of 20 Days of activities). It has a recommended four-week completion period. Completing each Day's activities take about 20-30 minutes. Most activities are under 5 minutes, with other longer activities.\n\nParticipants will receive the second assessment (T2) at week 7. Upon completion, they will then receive the electronic New Beginnings Program (eNBP). The eNBP is a self-guided online parenting course requiring participants to spend about 30 minutes per module for a total of six modules. It is designed to be completed in 6 weeks (one module per week). Participants will receive the third assessment (T3) at week 14.",[105,106],"Behavioral: Healing Hearts","Behavioral: electronic New Beginnings Program",{"label":108,"type":109,"description":110,"interventionNames":111},"electronic New Beginnings program","ACTIVE_COMPARATOR","Participants receive eNBP after baseline randomization. This is the only intervention they receive in this condition.\n\nThe eNBP is a self-guided online parenting course requiring participants to spend about 30 minutes per module for a total of six modules. It is designed to be completed in 6 weeks (one module per week).\n\nParticipants will receive the second assessment (T2) at week 7 and the third assessment (T3) at week 14.",[106],{"label":113,"type":109,"description":114,"interventionNames":115},"Internet Resources","Participants receive a curated list of online educational resources relevant to parenting and family wellbeing throughout the study period. They do not receive Healing Hearts or eNBP during the active comparison period. Assessments follow the same schedule as the other arms. Optional access after study assessments is outside the randomized intervention period.",[116],"Behavioral: Curated internet resources",[118,123,127],{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":88},"BEHAVIORAL","Healing Hearts","Four-Part self-guided web program with daily guided practices, lessons, journal and reflection activities.",[101],{"type":119,"name":124,"description":125,"armGroupLabels":126,"otherNames":88},"electronic New Beginnings Program","Online parenting skills program containing six modules. Each module takes 30 minutes to complete and contains home practice outside of the program. Prior studies have evaluated the efficacy of this program.",[101,108],{"type":119,"name":128,"description":129,"armGroupLabels":130,"otherNames":88},"Curated internet resources","Educational information comparator.",[113],[132],{"name":133,"role":134,"phone":135,"phoneExt":88,"email":136},"Na Zhang, PhD","CONTACT","2035617045","nazhang@uconn.edu",[138],{"facility":5,"status":139,"city":140,"state":141,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"RECRUITING","Stamford","Connecticut","06901","United States","US",{"type":146,"coordinates":147},"Point",[148,149],-73.53873,41.05343,{"lat":149,"lon":148},[152],{"name":153,"role":134,"phone":135,"phoneExt":88,"email":136},"Zhang",{"type":155,"investigatorFullName":156,"investigatorTitle":157,"investigatorAffiliation":5,"oldNameTitle":88,"oldOrganization":88},"PRINCIPAL_INVESTIGATOR","Na Zhang","Associate Professor",[159],{"name":160,"class":161},"National Institute of Mental Health (NIMH)","NIH","100659987","healing-hearts-a-mindfulness-app-for-parents-navigating-divorce-or-separation-100659987",false,"NCT07871916","Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation","A Digital Mindfulness-informed Parenting Intervention for High-risk Divorced Families","Inclusion Criteria:\n\n* Age 18 years or older.\n* Able to speak, read, and write in English; living in the United States.\n* Has a mobile device, internet access on that device, and uses email.\n* Identifies as a parent and has at least one child aged 6 to 18 years with an ex-partner. Parenting time with the target child exceeds 3 hours\u002Fweek.\n* Is going through a legal process to separate or divorce; or was married and divorced or legally separated within the past 3 years; or was never married to the ex-partner and has a qualifying separation marker within the past 3 years.\n* For never-married parents, the listed markers are child custody, visitation, or formal parenting-plan proceedings or agreements; child-support proceedings or agreements; dissolution of a domestic partnership or civil union; or either partner moving out and maintaining separate households.\n* Reports a Kessler 6 psychological distress score from 1 through 12, inclusive.\n\nExclusion Criteria:\n\n* Low-speed internet.\n* Current regular mind-body practices, such as meditation or yoga.\n* The parent or target child is in psychotherapy or other clinical research.\n* Kessler 6 score of 0 or 13 or higher.\n* History of major psychiatric disorders.\n* Current alcohol use problems.",true,"ALL","18 Years",{"count":173,"type":174},96,"ESTIMATED","INTERVENTIONAL",[177],"NA","This study examines online programs for parents navigating divorce or separation. Researchers will study whether a self-guided mindfulness app called Healing Hearts, followed by a self-guided online parenting program called the electronic New Beginnings Program, is feasible and acceptable to parents and shows promising effects on parent and child wellbeing. Ninety-six parents who live in the United States, have a child aged 6 to 18 with a former partner, and report mild to moderate psychological distress will be randomly assigned to one of three groups: Healing Hearts followed by the parenting program, the parenting program alone, or a set of online educational resources. Participants complete online assessments before assignment, about seven weeks later, and about seven weeks after the second assessment. The study measures parent wellbeing, parenting, parent reports of child behavior, program use, and participant experiences. All participation takes place remotely.",[180,181,182,183,184,185,186,187,188],"Mental Health","Parenting \u002F Maternal Behavior","Parenting Anxiety","Parenting Behavior","Stress","Psychological Distress","Depression and Anxiety Symptoms","Internalizing Problems","Externalizing Problems",[190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211],"divorce","parental separation","divorced parent","separated parent","mindfulness","mindful parenting","parenting stress","parental distress","parenting skill","coparenting","family court","child visitation","web-based intervention","online parenting program","parent education","pilot randomized controlled trial","child emotional problems","child behavioral problems","remote study","family law","divorcing","interparental conflict","2026-10-06",{"date":214,"type":215},"2026-10-13","ACTUAL",{"date":217,"type":174},"2026-10-05",{"date":219,"type":174},"2027-07-30",{"name":5,"class":6},1]