A randomized,controlled trial of a community-based support program for families of children with chronic illness: pediatric outcomes

BACKGROUND: Children with chronic illnesses have a heightened risk for mental health problems. OBJECTIVES: To develop, implement, and evaluate child outcomes of a 15-month, community-based, family-support intervention designed to reduce risk for poor adjustment and mental health problems in children with 1 of 4 chronic illnesses (diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma) and their mothers. DESIGN: Randomized, controlled clinical trial design with multiple measures of mental health based on both child and parent reports taken 1 year apart. SETTING: Community-based intervention linked to subspecialty and general pediatric clinics and practices in Baltimore, Md. PARTICIPANTS: One hundred thirty-six mothers and children aged 7 to 11 years with diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma. INTERVENTION: The program, provided by "experienced mothers" and child life specialists, included telephone contacts, face-to-face visits, and special family events. MAIN OUTCOME MEASURES: Outcomes were measured using the following instruments: the Personal Adjustment and Role Skills Scale III, the Children's Depression Inventory, the Revised Children's Manifest Anxiety Scale, and the Self-Perception Profile for Children. RESULTS: The experimental group's mean adjustment score increased over the intervention period while the control group's mean adjustment score decreased. Analysis of variance demonstrated that the intervention had a significant main effect on postintervention adjustment controlling for baseline scores (P =.01). Using a cutoff score indicating maladjustment, the percentage of experimental group children in the maladjustment range fell from 19% at baseline to 10% after the intervention; the percentage of control group children in the maladjustment range rose from 15% at baseline to 21% after the intervention. The effect of the intervention was more pronounced for children who had low physical self-esteem than for those who had moderate to high physical self-esteem at the beginning of the program. CONCLUSIONS: Our results demonstrate modest positive effects of a family support intervention in promoting the adjustment of children with selective chronic health conditions. Including child life specialists in a community-based intervention may be especially salient for children with chronic illnesses who have low physical self-esteem. The intervention had a similar outcome for all diagnostic groups, suggesting that it could be effective for children with any chronic illness and implemented in a variety of pediatric settings.     

Evaluation of a bicycle skills training program for young children: a randomized controlled trial

Objective—To evaluate the effectiveness of a skills training program in improving safe cycling behavior, knowledge, and attitudes in young children.

Methods—Grade 4 children from six elementary schools in East York (a borough of Metropolitan Toronto) participated. The intervention—playground based instruction on bicycle handling skills by certified instructors—was randomly allocated to three schools. Altogether 141 children participated: 73 in the intervention group and 68 in the control group, with follow up evaluations available on 117 (83%). The primary outcome was safe cycling behavior (straight line riding, coming to a complete stop, and shoulder checking before a left turn). A self report questionnaire collected data on knowledge and attitudes. Baseline assessments were made in June, with follow up evaluations in September, 1995.

Results—The prevalence of safe cycling behaviors at follow up in the intervention and control groups respectively, were: straight line riding (90% v 88%; p=0.782), coming to a complete stop (90% v 76%; p=0.225), and shoulder checking (0% v 2%; p=1.000). Over time (from baseline to follow up) children in both groups were more likely to maintain straight line riding, less likely to ride on the sidewalk, and less likely to consider that a car had more right to the road.

Conclusions—This brief skills training program was not effective in improving safe cycling behavior, knowledge, or attitudes among grade 4 children.

     

A randomized, controlled trial of a home-based intervention program for children with autism and developmental delay

OBJECTIVE: This study aimed to (1) investigate whether provision of a home-based program in addition to a center-based program improves development in young children with disabilities and coping abilities of their families and (2) describe the characteristics of children and families who benefit most from the intervention. METHODS: Fifty-nine children, aged 3-5 years, with no cerebral palsy, participated in the study. Half of the group was randomized to receive an additional program in their homes. A special education teacher provided 40 visits over 12 months working with the families to help generalize skills to the home environment and assist with their concerns. All children were assessed before and after the intervention, and families completed questionnaires assessing family stress, support, and empowerment on both occasions. Differences in change over time and between the intervention and control group were analyzed by repeated measures and the association between characteristics of children and families with improved outcome by multivariate analysis of variance. RESULTS: Change in cognitive development and behavior (in the centers) over time favored the children who received the extra intervention (p = .007 and p = .007, respectively). The groups did not differ on any of the family measures of change. Multivariate analysis of variance revealed more improvement for children in the intervention group from higher than lower stressed families. CONCLUSIONS: Results suggest the need for daily reinforcement of skills learned at the center-based program and the importance of involving families, especially those with few resources and relatively high stress.     

Randomised trial of parental support for families with very preterm children

AIM—To test the effectiveness of a home based developmental education programme in very preterm children.METHODS—A randomised controlled trial was conducted of developmental or social support intervention, started at discharge for up to 2 years, in 309 consecutive survivors of 32 weeks gestation or less, born to mothers resident in greater Bristol between December 1990 and July 1993. Home visits were made by research nurses trained in either Portage (a developmental education programme) or in non-directional counselling (parent adviser scheme). Interventions were also provided to appropriate primary care and community support for disability. Griffiths Mental Development Scales were used to assess outcome at 2years.RESULTS—Mean (SEM) Griffiths quotients (GQ) were: Portage 96.8 (1.6); parent adviser 95.9 (1.6); preterm control 92.9 (2.0). Despite randomisation, social variables significantly confounded these results. Using linear regression analysis, intervention was associated with improved scores: Portage: + 4.3 GQ points (95% CI 1.6 to 7.0); parent adviser: +3.4 GQ points (1.4 to 6.1). The effect of Portage was greatest in those children with birthweights <1250 g (+5.3 GQ points (0.2 to 10.4) and in those with an abnormal neonatal cerebral ultrasound scan (+7.3 GQ points (1.6 to 13.0).CONCLUSION—Primary analysis showed no developmental benefit from long term family support after preterm birth. Secondary analysis controlling for the presence of adverse social markers showed similar small advantage for both intervention groups. In the smallest infants and those with brain injuries, a structured developmental programme may offer advantage over social support intervention.     

Maternal reports of raising children with chronic illnesses:the prevalence of positive thinking.

OBJECTIVE: To examine maternal reports of the positive impact and potential benefits of a child's chronic health condition. DESIGN AND METHODS: A total of 190 mothers and their children with chronic illnesses, including sickle cell disease, cystic fibrosis, diabetes mellitus, and asthma, were recruited from 12 specialty or general pediatric clinics in Baltimore, Md. Standardized interviews were conducted with the mothers and included demographics, condition-related variables, and positive aspects of raising a child with a chronic condition. RESULTS: Eighty-eight percent of the mothers felt better about themselves by learning to manage their child's chronic condition; 70% felt that their families were stronger because of their child's condition; and 80% felt that their family had benefited in some way from having a child with a chronic illness. Ninety-eight percent of the mothers endorsed at least 1 positive item; 58% endorsed all 3. CONCLUSIONS: Asking mothers about the positive impact on a family of a child's chronic illness captures an important part of the experience of caregiving. Physicians' recognition and encouragement of this positive outlook may help families continue to face the challenges of raising a child with a chronic illness.     

Improving the psychological status of children with asthma: a randomized controlled trial.

Children with asthma are at special risk for problems in psychological functioning, as are children with other chronic illnesses. We conducted a controlled trial of a combined education and stress management program among children ages 6 to 14 years with asthma. Eighty-one children were randomly assigned to an intervention or a control group; 56 children completed data collection, 29 intervention and 27 control. Psychological status was assessed by the Child Behavior Checklist (CBCL) before and after the intervention, as were children's knowledge of asthma, stress (as measured by children's life events), and functional status (as indicated by such activities as school attendance, time playing with friends, and daily chore performance). Children in the intervention group had a significant improvement in the total Behavior Problems score (p less than .04) and Internalizing scale (p less than .01) on the CBCL and a significant increase in daily chores (p less than .04) compared with the control group. Before intervention, the two groups had statistically significant positive relationships between negative life events and behavior problems scores. After intervention, children in the control group still demonstrated a significant relationship between negative life events and total and Internalizing Behavior Problem scores, although participation in the intervention group negated that relationship. Children in the intervention group whose knowledge of asthma increased were more likely to report an increase in daily chores (p less than .02). We conclude that the intervention had a beneficial effect on psychological status and on children's daily activities. The effect may have occurred in part by decreasing the likelihood that perceived stress from negative life events led to poorer adjustment.     

Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial

ABSTRACT: BACKGROUND: The prevalence of chronic suppurative lung disease (CSLD) and bronchiectasis unrelated to cystic fibrosis (CF) among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis.Methods/designWe are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis) with no underlying disease identified (such as CF or primary immunodeficiency), and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week) or placebo (once a week) for 12--24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children [GREATER-THAN OR EQUAL TO]6 years), and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical assessments every 3 to 4 months for up to 24 months from study entry are recorded on standardised forms. DISCUSSION: Should this trial demonstrate that azithromycin is efficacious in reducing the number of pulmonary exacerbations, it will provide a much-needed rationale for the use of long-term antibiotics in the medical management of bronchiectasis in Indigenous children.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12610000383066.     

儿童原发性夜间遗尿症治疗的临床随机对照研究

目的对3种遗尿症治疗方法进行临床随机对照研究,比较各种治疗方法的特点以及对原发性夜间遗尿症儿童的疗效。方法以138例确诊为原发性单一症状性夜间遗尿症的患儿为研究对象,在家长和患儿同意进行4个月的治疗并坚持随访情况下,将其随机分为3组：（1）生理．心理治疗组52例,使用报警器的条件反射训练与其他心理行为治疗整合的一体化方法;（2）药物治疗组46例,口服去氨加压素片剂;（3）综合治疗组40例,同时应用前两种方法治疗。家长和患儿决定暂不治疗或延期治疗的45例患儿归为对照组,并定期随访。对4组患儿4个月治疗结束时,和停止治疗3个月后遗尿的缓解情况进行比较分析。结果生理-心理治疗组的近期和远期治愈率分别为75．0％、71．2％;药物治疗组的近期和远期治愈率分别为47．8％、28．3％;综合治疗组的近期和远期治愈率分别为85．0％、80．0％。生理-心理治疗组与综合治疗组的近期、远期疗效均显著优于药物治疗组（P〈0．01）,生理-心理治疗组与综合治疗组的近期远期疗效差异无统计学意义（P〉0．05）。生理．心理治疗组起效慢、疗效巩固;药物治疗组起效快,停药后复发率高。结论 生理-心理治疗和药物去氨加压素治疗对我国儿童具有良好疗效。生理-心理治疗立足于发展儿童的夜间排尿控制能力,较药物治疗疗效更好,且复发率明显低于药物治疗,值得在国内遗尿症治疗中推广应用。     

A randomized controlled trial of preschool-based joint attention intervention for children with autism

Background: Deficits in joint attention (JA) and joint engagement (JE) represent a core problem in young children with autism as these affect language and social development. Studies of parent‐mediated and specialist‐mediated JA‐intervention suggest that such intervention may be effective. However, there is little knowledge about the success of the intervention when done in preschools. Aim: Assess the effects of a preschool‐based JA‐intervention. Methods: 61 children (48 males) with autistic disorder (29–60 months) were randomized to either 8 weeks of JA‐intervention, in addition to their preschool programs (n = 34), or to preschool programs only (n = 27). The intervention was done by preschool teachers with weekly supervision by trained counselors from Child and Adolescent Mental Health Clinics (CAMHC). Changes in JA and JE were measured by blinded independent testers using Early Social Communication Scale (ESCS) and video taped preschool teacher–child and mother–child play at baseline and post‐intervention. Clinical trials registration: Clinicaltrials.gov : NCT00378157. Results: Intention‐to‐treat analysis showed significant difference between the intervention and the control group, with the intervention group yielding more JA initiation during interaction with the preschool teachers. The effect generalized to significantly longer duration of JE with the mothers. Conclusions: This is the first randomized study to show positive and generalized effects of preschool‐based JA‐intervention.