Much emphasis has been placed on participant's psychological safety within genomic research studies; however, few studies have addressed parental psychological health effects associated with their child's participation in genomic studies, particularly when parents meet the threshold for clinical concern for depression. We aimed to determine if parents’ depressive symptoms were associated with their child's participation in a randomized-controlled trial of newborn exome sequencing. Parents completed the Edinburgh Postnatal Depression Scale (EPDS) at baseline, immediately post-disclosure, and 3 months post-disclosure. Mothers and fathers scoring at or above thresholds for clinical concern on the EPDS, 12 and 10, respectively, indicating possible Major Depressive Disorder with Peripartum Onset, were contacted by study staff for mental health screening. Parental concerns identified in follow-up conversations were coded for themes. Forty-five parents had EPDS scores above the clinical threshold at baseline, which decreased by an average of 2.9 points immediately post-disclosure and another 1.1 points 3 months post-disclosure (both p ≤ .014). For 28 parents, EPDS scores were below the threshold for clinical concern at baseline, increased by an average of 4.7 points into the elevated range immediately post-disclosure, and decreased by 3.8 points at 3 months post-disclosure (both p < .001). Nine parents scored above thresholds only at 3 months post-disclosure after increasing an average of 5.7 points from immediately post-disclosure (p < .001). Of the 82 parents who scored above the threshold at any time point, 43 (52.4%) were reached and 30 (69.7%) of these 43 parents attributed their elevated scores to parenting stress, balancing work and family responsibilities, and/or child health concerns. Only three parents (7.0%) raised concerns about their participation in the trial, particularly their randomization to the control arm. Elevated scores on the EPDS were typically transient and parents attributed their symptomatology to life stressors in the postpartum period rather than participation in a trial of newborn exome sequencing.

中文翻译：

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参与美国新生儿基因组测序试验对有抑郁风险的父母的影响

基因组研究非常重视参与者的心理安全；然而，很少有研究涉及与孩子参与基因组研究相关的父母心理健康影响，特别是当父母达到临床关注抑郁症的阈值时。我们的目的是确定父母的抑郁症状是否与其孩子参与新生儿外显子组测序的随机对照试验有关。父母在基线、披露后立即和披露后 3 个月完成了爱丁堡产后抑郁量表 (EPDS)。母亲和父亲在 EPDS 上得分达到或超过临床关注阈值，分别为 12 和 10，表明可能患有围产期发作的重度抑郁症，研究人员联系了他们进行心理健康筛查。在后续对话中确定的父母关注点被编码为主题。45 位家长的 EPDS 分数在基线时高于临床阈值，披露后立即平均下降 2.9 分，披露后 3 个月又下降 1.1 分（两者均p  ≤ .014）。对于 28 位家长，EPDS 分数在基线时低于临床关注的阈值，在公开后立即平均增加 4.7 分进入升高范围，并在公开后 3 个月减少 3.8 分（均 p < .001  ） . 9 名家长仅在披露后 3 个月得分高于阈值，从披露后立即平均增加 5.7 分（p <.001）。在任何时间点得分超过阈值的 82 位父母中，有 43 位 (52.4%) 达到了，这 43 位父母中的 30 位 (69.7%) 将他们的高分归因于养育压力、平衡工作和家庭责任，和/或儿童健康担忧。只有三位家长 (7.0%) 对他们参与试验表示担忧，尤其是他们被随机分配到对照组。EPDS 得分升高通常是短暂的，父母将他们的症状归因于产后的生活压力，而不是参与新生儿外显子组测序试验。