Parents' attitudes toward the use of complementary therapy by their children with moderate or severe cerebral palsy.

OBJECTIVE: To describe the use of, and attitudes toward, complementary therapy (CT) by parents of children with moderate to severe cerebral palsy. METHODS: Parents of 32 children with cerebral palsy (age 5-12 years) enrolled in a randomized trial of cranial osteopathy prospectively participated in semi-structured interviews in the home to explore the use of CT and views regarding access to and expectations of these therapies. Interview transcripts were analyzed thematically, and content analysis was used to determine the frequency of use of different therapies. RESULTS: Sixteen children (50%) had received one or more types of CT, although only three were currently receiving any CT. The primary reasons for trying CT were to reduce children's pain and improve physical function. Parents had limited knowledge of the range of, and possible indications for, CT and expressed concerns about CT safety and effectiveness. Practical considerations of time and cost were also identified. Some parents had strong beliefs about the benefits, and, overall, parents indicated a high level of commitment to finding any treatments, conventional or CT, to help their children. CONCLUSION: Parents of children with cerebral palsy want to help their child, but they need information, guidance, and practical support to facilitate their decision-making regarding the use of CT. A clearer understanding of factors predictive of optimal outcomes will enable resources to be targeted effectively.

Cranial osteopathy for children with cerebral palsy: a randomised controlled trial.

OBJECTIVES: To estimate the effect of cranial osteopathy on the general health and wellbeing, including physical functioning, of children with cerebral palsy. DESIGN: Pragmatic randomised controlled trial. PARTICIPANTS: 142 children from Greater London and the South West of England, aged 5-12 years with cerebral palsy. INTERVENTION: Participants were randomised to six sessions of cranial osteopathy with a registered osteopath or a waiting list with partial attention control (parents invited to participate in two semistructured interviews). PRIMARY OUTCOME MEASURES: Blind assessment of motor function by physiotherapists using the Gross Motor Function Measure-66 (GMFM-66) and quality of life using the Child Health Questionnaire (CHQ) PF50 at 6 months. SECONDARY OUTCOME MEASURES: Parents' assessment of global health and sleep at 6 months, pain and sleep diaries at 10 weeks and 6 months, CHQ PF50 at 10 weeks and quality of life of main carer (Short Form 36) at 10 weeks and 6 months. RESULTS: Compared with children in the control group, children in the osteopathy group demonstrated no statistically significant differences in GMFM-66 (mean difference 4.9, 95% CI -4.4 to 14.1), CHQ Physical Summary Score (mean difference 2.2, 95% CI -3.5 to 8.0) or CHQ Psychological Summary Score (mean difference 3.4, 95% CI -0.8 to 7.7). There were no significant differences between groups with respect to pain; sleep (either 'time asleep' or 'time to sleep'); or main carer's quality of life. Compared with children in the control group, carers of children receiving cranial osteopathy were nearly twice as likely to report that their child's global health had 'improved' at 6 months rather than 'decreased' or 'remained the same' (38% vs 18%; odds ratio 2.8, 95% CI 1.1 to 6.9). CONCLUSIONS: This trial found no statistically significant evidence that cranial osteopathy leads to sustained improvement in motor function, pain, sleep or quality of life in children aged 5-12 years with cerebral palsy nor in quality of life of their carers.

Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy.

BACKGROUND: Although the UK Department of Health has advocated the involvement of service users and carers in health research for several years, there is little evidence about their contribution to the design of randomized controlled trials (RCTs). OBJECTIVE: To demonstrate how consulting parents about the design of a study, including which outcomes to use, led to the design and successful delivery of a RCT of osteopathy for children with cerebral palsy (CP). DESIGN: Semi-structured interviews were carried out with 20 parents of children with CP and other neurological conditions, asking them to choose between four different trial designs, to talk about noticeable changes in their child's condition and their views about payment for trial treatment. SETTING AND PARTICIPANTS: The parents interviewed were all members of Cerebra, a charity for 'brain-injured' children and young people. All interviews were carried out at the parents' homes. RESULTS: Parents had mixed views about possible trial designs; however, a waitlist design which allowed all children eventually to receive the treatment emerged as a clear favourite. Parents did not focus on isolated outcomes, but suggested a range of factors relevant to their child's quality of life. They expressed a clear preference for the costs of treatment to be funded by the trial. CONCLUSIONS: Involvement of parents helped design a trial which was acceptable to families and addressed outcomes that mattered to them. By consulting parents about the design of the research, the subsequent trial achieved excellent recruitment and retention rates.

Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial.

OBJECTIVES: To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome. DESIGN: Randomised controlled trial with two by two factorial design. SETTING: Children living in the Midlands, Greater London, and the south west of England. PARTICIPANTS: 156 infants aged under 7 months with trisomy 21. INTERVENTION: Daily oral supplementation with antioxidants (selenium 10 mug, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo. MAIN OUTCOME MEASURES: Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months. RESULTS: Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval -2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, -1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results. CONCLUSIONS: This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome. TRIAL REGISTRATION: Clinical trials NCT00378456.

Inequalities in provision of the Disability Living Allowance for Down syndrome.

OBJECTIVES: To assess factors associated with granting of the Disability Living Allowance (DLA) for Down syndrome. DESIGN: Cross-sectional survey. SETTING: Families with a child with Down syndrome enrolled in a community-based trial of vitamin supplementation. PARTICIPANTS: 156 children with trisomy 21 (59% male, 20% non-white) were enrolled before 7 months of age and 138 completed follow-up. MAIN OUTCOME MEASURES: Before the child was 2 years old, we surveyed parents about applications for the DLA and socioeconomic factors, and assessed the child's development. RESULTS: Application for the DLA was not associated with ethnicity or speaking English. Significantly fewer ethnic minority parents (OR = 0.10; 95% CI 0.03 to 0.35; 69% vs 96%, risk difference 27%) and parents with English as a second language (OR = 0.15: 95% CI 0.04 to 0.62; 67% vs 93%, risk difference 26%) were granted the DLA. Amongst those granted the DLA, ethnic minority families were significantly less likely to be granted a higher monetary award (OR = 0.19; 95% CI 0.06 to 0.55). Severity of disability, reflected by quartile of Griffiths Developmental Quotient or the presence of severe cardiac disease requiring surgery, was not associated with application, granting or level of the DLA award. CONCLUSIONS: Although all children with Down syndrome meet some of the criteria for the DLA, only 80% were receiving this benefit. The decision to award the DLA and the monetary level of the award favoured white, English speaking parents and was not related to severity of disability. Routine monitoring of awards by ethnicity and language spoken is needed. TRIAL REGISTRATION NUMBER: NCT00378456.