Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial.

INTRODUCTION: There are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access and efficiency. This multisite randomised controlled trial evaluates how a coach-enhanced digital cognitive behavioural intervention (dCBI) enhances usual care for depressed AYAs in paediatric practices with minority enriched samples. METHODS AND ANALYSIS: Participants (n=750) ages 16-22 who meet threshold criteria for depressive severity (Patient Health Questionnaire-9; PHQ-9 score 10-24) will be recruited through paediatric practices across three academic institutions (Boston, Pittsburgh and San Diego). Participants will be randomised to 12 weeks of dCBI+treatment as usual (TAU) (n=450) or TAU alone (n=300) in outpatient paediatric practices. Assessments will be completed at baseline, 6 weeks and 12 weeks with the primary outcome being improvement in clinician-rated and self-reported depressive severity (Children's Depression Rating Scale-Revised and PHQ-9) and secondary outcomes being self-reported suicidal ideation (item 9 on PHQ-9), anxiety severity (Generalised Anxiety Disorder), general quality of life (Satisfaction with Life Scale) and general functioning (Children's Global Assessment Scale). The study design is an intent-to-treat mixed effects regression with group, and covariates nested within the sites. ETHICS AND DISSEMINATION: All participants or their parent/guardian (under 18 years or unemancipated) will give informed consent to a study team member. All data are expected to be collected over 18 months. The Institutional Review Board (IRB) is a board at each institution in the United States that reviews and monitors research involving human subjects. IRB approval from the University of Pittsburgh was obtained on 30 November 2021 (STUDY21080150), from the University of California San Diego's Human Research Protection Program IRB on 14 July 2022 (802047), and from the Boston Children's Hospital IRB on 25 October 2022 (P00040987). Full study results are planned to be published within 2 years of initial study recruitment (October 2024). Dissemination of findings will occur in peer-reviewed journals, professional conferences and through reports to participating entities and stakeholders. TRIAL REGISTRATION NUMBER: NCT05159713; ClinicalTrials.gov.

Bispectral index monitoring in children undergoing mild hypothermic cardiopulmonary bypass.

BACKGROUND: In this prospective, cohort study of 15 children (median age 7.7 years, range 4.9-16.5 years) undergoing atrial septal defect repair, we evaluated changes in the Bispectral index (BIS) as a potential monitor of level of consciousness during cardiac anaesthesia. METHODS: Identical cardiac surgery, cardiopulmonary bypass (CPB) and anaesthetic techniques were used, including mild hypothermia and an early extubation protocol. BIS, mean arterial pressure, heart rate and tympanic temperature were recorded at baseline postinduction (Tbaseline), skin incision (Tincis), sternotomy (Tsternot), aortic cannulation (Tcann), nadir temperature (Tnadir), rewarmed (Trewarmed), immediate post-CPB (TpostCPB), chest drain insertion (Tdrains), sternal wires (Twire), skin closure (Tclosed) and spontaneous movement (Tmove). As a measure of stress response, serum lactate, glucose, norepinephrine and epinephrine levels were measured at Tbaseline, Tsternot, Tcann, Tnadir, Trewarmed and Tdrains. Explicit memory testing was undertaken prior to hospital discharge. RESULTS: BIS increased significantly during the rewarming phase (Trewarmed versus Tbaseline and Tnadir, P<0.001). Lactate, epinephrine and glucose levels were also significantly elevated at Trewarmed. There were no correlations between BIS and the increase in epinephrine, lactate and glucose during rewarming, nor with changes in heart rate or mean arterial pressure during surgery. All patients had an uneventful recovery without evidence for explicit recall. CONCLUSIONS: The increase in BIS during the rewarming phase could reflect an increase in conscious level, and is consistent with the reported risk for awareness during this phase of cardiac surgery.

Zora: a pilot virtual community in the pediatric dialysis unit.

We describe a five-month pilot project conducted in the dialysis unit at Boston's Children's Hospital. Pediatric patients with renal disease used the Zora therapeutic community program while undergoing hemodialysis. Zora is a 3D multi-user computer environment designed at the MIT Media Laboratory to help young people explore issues of identity, while engaging in a virtual community. Users build "virtual rooms" and populate them with objects and characters, program them with storytelling behaviors, and converse with other young people in real-time through a virtual character representing themselves. It was specifically designed to help young people explore issues of identity, while engaging in a participatory virtual community. This paper presents the experience and evaluates the feasibility and safety of using Zora in a hospital setting. It describes how Zora facilitated explorations of identity and mutual patient support and interaction. Finally it also presents design recommendations for future interventions of this kind. More generally, this paper explores the potential of technology specifically designed with therapeutic purposes to help patients cope with their illness.

Using process evaluation to describe a hospital-based clinic for children coping with medical stressors.

OBJECTIVE: To use process evaluation methods to describe the development of a hospital-based mental health clinic for children facing medical stressors. METHODS: Over a 21-month time period, we collected data regarding presenting concern, service use, and referral source using hospital administrative, clinic intake, and clinical records for 356 children. RESULTS: Nearly 90% of the children were referred to the clinic from sources within the hospital. With the exception of single session interventions, there were no differences in average length of services according to presenting concern. Hospital pediatric specialists and psychology consultants were the primary referrers to the program. Pediatric specialists referred more often for procedural concerns and chronic illness than other hospital referrers. CONCLUSIONS: These findings support the feasibility and usefulness of a process evaluation approach in shaping clinical program directions, creating opportunities for collaboration with medical providers, and planning effectiveness research.

Illness-related concerns of mothers of children with congenital heart disease.

OBJECTIVE: This study examined concerns expressed by mothers of children with congenital heart disease (CHD). The relationships among mothers' concerns, medical severity, and mother's emotional state were examined at two points in time. METHOD: Thirty-eight mothers of children with CHD aged 3 to 16 completed semistructured interviews and rating scales during hospitalization and 2 to 4 weeks after discharge. Mothers rated their distress about illness-related concerns, as well as their own depressed mood and anxiety. Mothers and two cardiologists rated the medical severity of each child's disease. RESULTS: Mothers' concerns were reliably grouped into five categories: medical prognosis, quality of life, psychosocial functioning, effects on family, and financial issues. During hospitalization, mothers were most concerned about medical prognosis. Distress about most concerns decreased postdischarge, as did mother's anxiety and depressed mood. Mothers' perceptions of medical severity were associated with distress about psychosocial issues postdischarge. Mother's anxiety was not associated with number of concerns reported, or with distress about those concerns. Maternal depressed mood was associated with fewer illness-related concerns, but greater distress about those concerns. CONCLUSIONS: Illness-related concerns can be meaningfully categorized and are not necessarily a function of disease severity or mother's emotional state. An awareness of common concerns will improve clinical care by enabling practitioners to anticipate and address concerns in a proactive way. The results may inform the development of supportive mental health interventions for families of children with CHD.

The prenatal visit.

In their role as advocates for children and families, pediatricians are in an excellent position to support and guide parents during the prenatal period. Prenatal visits allow the pediatrician to gather basic information from parents, provide information and advice to them, and identify high-risk situations in which parents may need to be referred to appropriate resources for help. In addition, prenatal visits are the first step in establishing a relationship between the pediatrician and parents and help parents develop parenting skills. The prenatal visit may take several possible forms depending on the experience and preferences of the parents, competence and availability of the pediatrician, and provisions of the health care plan.

Implementation of an electronic medical record system in a pediatric psychopharmacology program.

The design, implementation, and utilization of an electronic medical record system (EMRS) in a pediatric psychopharmacology clinic is described. The EMRS is a relational database with information entered directly by the clinician during a patient visit. It has been used during more than 2590 patient visits with 805 patients. Complete clinical documentation and simultaneous data entry as well as computer generated prescriptions for the patient were accomplished 75% of the time within a 20-min medication management session. One hundred consecutive parents of patients were asked to fill out a five-question survey to begin to assess the impact of the application. Of the 87 parents who responded, all (100%) noted that the doctor paid attention to their concerns. Between 88 and 90% of the parents reported that the use of the computer is a 'good' thing, made it easier to work with the doctor, and that they understood why the computer was being used. The findings support that the development and implementation of an EMRS with direct clinician information entry within pediatric psychopharmacology clinic, is feasible.

The experience journal: a computer-based intervention for families facing congenital heart disease.

OBJECTIVE: To test the feasibility and safety of a computer-based application designed to facilitate the healthy coping of children and their families who must contend with significant congenital heart disease (CHD). The application, called the Experience Journal (EJ), is a psychoeducational intervention based on a narrative model involving the sharing of personal stories about an illness. METHOD: Testing was conducted in 2 phases. In phase 1, 9 parents of children with CHD and 1 adult with CHD were asked to use the EJ. After utilization, semistructured interviews assessed EJ usability and safety. In phase 2, 40 mothers of children with CHD used the EJ during a hospitalization. Assessment of feasibility and safety was measured through the use of semistructured interviews prior to EJ utilization and 2 to 4 weeks after hospital discharge. RESULTS: Results revealed that the EJ was safe and useful for decreasing social isolation, increasing understanding of familial feelings about cardiac illness, and fostering positive reactions in mothers. CONCLUSIONS: Computer-based interventions that present psychoeducational and medical information closely connected to "one's own story" may open up new possibilities for families facing pediatric illnesses.

Psychological functioning in children and adolescents undergoing radiofrequency catheter ablation.

This study examined 38 patients (age 6-18 years) with recurrent cardiac arrhythmias who underwent radiofrequency catheter ablation of ectopic myocardial foci. Psychological functioning was assessed by the Pediatric Symptom Checklist, Short Mood and Feeling Questionnaire, Revised Children's Manifest Anxiety Scale, and Arrhythmia Anxiety Queries prior to ablation and at 3-month follow-up. The patients resembled a normal population without elevations in anxiety or depression. After ablation, the patients showed reductions in the "fear of their heart problem" and increases in "the things that they enjoy." The patients who underwent a curative ablation had better functioning than those who did not show improvement. Children appear to have the opportunity for an improved quality of life after ablation.

Postoperative recovery in children after minimum versus full-length sternotomy.

BACKGROUND: Minimal access incisions for pediatric cardiac surgery have been reported to hasten postoperative recovery. This prospective study compared recovery after a minimum versus full-length sternotomy for repair of atrial septal defects in children. METHODS: We studied 35 children undergoing atrial septal defect repair using a full-length sternotomy (n = 18) or ministernotomy (n = 17) according to the surgeon's preference. All children were managed according to an established clinical practice guideline. Intraoperative comparisons included patient demographics, bypass and cross-clamp times, and, as a measure of stress response, epinephrine, norepinephrine, and lactate levels at six time intervals throughout the surgical procedure. Postoperative comparisons included pain scores at 6, 12, and 24 hours, frequency of emesis, analgesic requirements, respiratory rate and gas exchange, and length of intensive care unit and total hospital stay. Nurse and parent assessment scores of overall recovery were constructed using visual analog and Likert scales. RESULTS: No significant differences between mini- versus full-length sternotomy were detected for the measured outcome variables. No adverse outcomes were detected. CONCLUSIONS: In this prospective study, a ministernotomy did not enhance postoperative recovery, and the primary advantage appears to be an improved cosmetic result.

Experience journals: using computers to share personal stories about illness and medical intervention.

Medical advances make it increasingly possible for children with previously fatal illness to live and thrive. However, a significant number still experience repeated operations, hospitalization, and invasive procedures, or need special care at home. Many do so with little or no intervention to help them and their families cope with the emotional stresses involved. One significant source of emotional and cognitive support is the community of patients and families who have experienced similar medical procedures. However, in spite of a general willingness to share experiences, communication among patients and families is usually limited. To facilitate this process, we are investigating the use of computer technology to record, organize, and display stories about the experiences of families with children who have been treated for cardiac and neurological illness at Children's Hospital, Boston. We are asking children and their families to record text and multimedia vignettes describing some aspect of their illness, coping strategies, or care that might be useful to others. These contributions will be available for browsing at a secure World-Wide-Web site. However, economic realities preclude reliance on a professional site administrator to organize and monitor what we hope to be a rapidly growing Web site with a large, distributed authorship. The need to make the Web site fully accessible to users who have varying familiarity with computers and Web browsing imposes further constraints. We are therefore developing software to automate the process of managing and organizing an easily accessed Web site that contains an "Experience Journal." We describe this software, the rationale for its development, and our plans for its use in the coming year.

Case study: seizure disorder presenting as panic disorder with agoraphobia.

Seizure disorders can produce anxiety that is almost indistinguishable from psychiatric disorders. There are few reports of adolescents with seizure disorders that produce fear. The first case of an adolescent female who presented with panic disorder and agoraphobia which was a consequence of seizure activity is reported. Careful diagnostic evaluation and correlation with video electroencephalography were important in distinguishing seizure activity from panic disorder.

Sertraline treatment of transition-associated anxiety and agitation in children with autistic disorder.

The intolerance of children with autistic disorder to changes in their routine or environment is well known, typically presenting with acute symptoms of anxiety, panic, irritability, or agitation. In a clinical sample of children (6-12 years old) with autistic disorder and transition-induced behavioral deterioration, 8 of 9 patients showed a clinically significant improvement in response to sertraline treatment. Only one child was taking concurrent psychotropic medication. Therapeutic doses were surprisingly low in all cases (25-50 mg daily), with a clinical response appearing generally in 2-8 weeks. Adverse effects were minimal (one child developed stomachaches), except for apparent sertraline-induced behavioral worsening in 2 children when their doses were raised to 75 mg daily. In 3 children, an initial satisfactory clinical response appeared to diminish after 3-7 months of treatment, despite steady or increased doses. In 6 patients, the beneficial effects persisted throughout the several-month follow-up period. Only four of the children's families were identified as having mood and/or anxiety disorders. This open-label study suggests that short-term sertraline treatment may reduce the behavioral reactions seen in association with situational transitions or environmental changes in children with autistic disorder, though the beneficial effect may be only temporary in some children. Our experience suggests that small doses of sertraline may be effective and that some children may require divided doses of sertraline during the day. Controlled studies are needed to determine the efficacy, safety, and pharmacokinetics of sertraline in treating this "need for sameness," both in short-term and long-term studies of children with autistic disorder.

Use of risperidone in psychotic disorder following ischemic brain damage.

Risperidone, a novel atypical neuroleptic agent, was used to treat a psychotic disorder secondary to ischemic brain damage in a 19-year-old adolescent, who had been treatment-refractory to two conventional antipsychotic agents and valproate. Clinically significant reductions in behavioral agitation and psychotic thinking initially appeared within the first 4 days of treatment with risperidone 3 mg twice daily. Risperidone was well tolerated despite this adolescent's severe cardiac and pulmonary illnesses. There was no evidence of increased neurotoxic symptoms in the presence of the ischemic brain damage. With its favorable side effect profile, risperidone may hold promise in the treatment of patients with psychotic disorders due to general medical conditions.

Impact of psychologic functioning, medical severity, and family functioning in pediatric heart transplantation.

BACKGROUND AND METHODS: This study examined (1) the psychologic functioning of children and adolescents before and after heart transplantation and (2) whether pretransplantation psychologic functioning, posttransplantation medical severity, and family functioning were related to the patients' posttransplantation psychologic functioning. The subjects were 23 patients, ages 3 to 20 years, who underwent heart transplant and survived at least 1 year after their transplantation. Psychologic functioning was assessed by the Children's Global Assessment Scale before and after heart transplantation. Medical severity was assessed by number of outpatient visits, hospitalizations, biopsies, and the Side Effect Severity Scale. Family functioning was rated on the Global Assessment of Family Relational Functioning Scale. RESULTS: The majority of the patients (78.3%) had good psychologic functioning after their heart transplantation. Patients with psychologic difficulties before and after transplantation had more hospitalizations after transplantation. CONCLUSIONS: Pretransplantation emotional functioning and family functioning were more correlated with posttransplantation psychologic functioning than medical side effect severity.

Current perspectives on the pharmacotherapy of depressive disorders in children and adolescents.

Major depressive disorder occurs in approximately 2% of prepubertal children and 5% of adolescents. Studies investigating the pharmacotherapy of early-onset major depressive disorder in these young patients have been inconclusive. Early open trials and anecdotal experience suggested a beneficial role for antidepressant therapy. Double-blind placebo-controlled trials have failed to demonstrate the robust response seen in adults, but the studies have been small and concerns have been raised regarding methodology. Nevertheless, the significant morbidity associated with depressive disorders and the positive open trial experiences with antidepressants have led to the recommendation that antidepressants be used early in life when a patient presents with symptoms of a depressive disorder and has significant functional incapacity because of these symptoms. This article will review the studies of antidepressant efficacy in juvenile-onset major depressive disorder and then propose a pharmacotherapy model.

The role of maternal factors in the adaptation of children with craniofacial disfigurement.

This study hypothesized that maternal adjustment, perceptions, and social support would better predict child adaptation to craniofacial disfigurement than medical severity. Mothers of 77 children (ages 6-12) completed the Child Behavior Checklist, Beck Depression Inventory, Spielberger Trait Anxiety Scale, Social Support Questionnaire Revised, and Parenting Stress Index. Medical severity was assessed by the number of operations (craniofacial and other), comorbid medical conditions, and the Hay Attractiveness Scale. The children and mothers in our sample resembled a normal population in terms of their psychological functioning and quality of the mother-child relationships. Maternal adjustment and maternal perceptions of the mother-child relationship were more potent predictors of children's emotional adjustment than either medical severity or maternal social support.

Depressive disorders and suicidal intent in adolescent suicide attempters.

This study describes the relationships between the presence of a depressive disorder, suicidal intent, and the medical seriousness of a suicide attempt in an adolescent sample. Consecutive adolescents who attempted suicide were evaluated for the presence or absence of current DSM-III-R depressive disorders (DD). Adolescent suicide attempters with DD were compared with those without DD regarding the level of their suicide intent and the medical seriousness of their suicide attempt. Adolescent suicide attempters with a diagnosis of DD were found to have a higher level of suicidal intent than were those without depressive illness. There was no relationship between the medical seriousness of the suicide attempt and the presence of DD. Clinicians should specifically assess for DSM-III-R DD as a means of determining suicidal intent in adolescent suicide attempters.