Background
Methods
Inclusion and Exclusion Criteria, participants and outcome measures
Identification of studies
Data management and quality assessment
Statistical Analysis
Results
Search results
Pharmacological Interventions (Table 1)
Study quality | Participants (n), age, inclusion criteria and setting | Interventions and follow-up | Outcome measures |
---|---|---|---|
Oesterheld et al, 1998[12] Cross-over RCT Randomized (method unclear); allocation concealment unclear; blinding (researchers, outcome assessors); follow-up 100%; ITT analysis unclear; study power not provided. | n = 4 5 to 12 years FAS or partial FAS[4] & ADHD (DSM-IV) Native American residential school | 0.6 mg/kg methylphenidate per dose to nearest 2.5 mg or lactose placebo or Vitamin C placebo Interventions were given 3 times per day for 5 days with a 2 day washout period prior to each intervention. Follow-up: Day 5 of each intervention |
Hyperactivity-Impulsivity score on CPRS-48: significant improvement in methylphenidate group (F = 4.34, df = 2, p < 0.05)
Hyperactivity-Impulsivity score on CTRS-39: significant improvement in methylphenidate group (F = 6.42, df2, p < 0.02)
Daydreaming-Attention score on Conners Teacher Rating Scale-39: no significant difference (F = 1.429, df2, p = 0.289)
Adverse events: three children experienced decreased appetite; two, mild stomach aches; and two, headaches. |
Snyder et al, 1997[13] Cross-over RCT Randomized (method unclear); allocation concealment unclear; blinding (researchers, outcome assessors); follow-up 92%; ITT analysis unclear; study power not provided. | n = 12 6 to 16 years FAS[4] & ADHD (DSM-IV) & reported positive response to stimulant medication Selected from a child development unit database, Canada | Usual dose of medication (methylphenidate: 8 children; pemoline: 2 children; dexedrine: 1 child) or colour matched capsule (placebo) Interventions were given for 3 days with a 1 day washout prior to each intervention. Usual medication was given for 3 days between the 2 interventions. Follow-up: Day 3 of each intervention |
Attention: No significant difference between groups on vigilance task and no significant difference on Underlining Test.
Hyperactivity: scores on the Abbreviated Symptoms Questionnaire – Parents were significantly improved for stimulant medication (68.36, SD 17.4) compared to placebo (84.4, SD 14.0) (F = 8.66; p = 0.016)
Adverse events: not reported |
Educational and learning strategies (Table 2)
Study quality | Participants (n), age, inclusion criteria and setting | Interventions and follow-up | Outcome measures |
---|---|---|---|
Adnams et al, 2003 In: Riley et al, 2003[14] RCT: randomization method, allocation concealment, blinding, ITT analysis unclear; follow-up 100%; study power not given. | n = 10, Mean age: 8.5 years FAS[3] Selected from previous study of 64 South African children | CCT or usual classroom, 1 hour per week, 10 school months. Follow-up: 10 months |
Behaviour: Personal Behaviours Checklist score: improvement in CCT group compared to controls (mean pre-intervention scores 21.4 vs 14.8 and mean post-intervention scores 7.6 vs 15.4).
Neuropsychological profile: no significant difference.
CCT battery: qualitative improvements in function but no significant difference |
RCT: randomization method, allocation concealment, ITT analysis unclear; outcome assessors blinded; follow-up 94%; study power not given. | n = 65, 9 to 10 years FAS or partial FAS[3] and "deferred diagnosis category" Exposed children selected from study of 105 South African children, | Language and literacy intervention, 1 hour per week for 38 weeks over 9 months Follow-up: 9 months |
Pre-literacy, reading and spelling: FASD children in intervention group had significantly improved scores on Phonological Awareness and Early Literacy Test: Manipulating Syllables (t = 2.23, p = 0.034), Letter Sounds (t = 3.7, p = 0.001), Written Letters (t = 3.14, p = 0.004), Reading (t = 3.72, p = 0.001), Reading Non-Words (t = 3.65, p = 0.001) and Spelling Non-Words (t = 3.44, p = 0.002).
General scholastic tests: No significant difference between FASD intervention and control group. |
Coles et al, 2007[17] RCT: randomization method, allocation concealment, ITT analysis unclear; outcome assessor blinded; follow-up 100%; study power not given. | n = 32 4 to 10 years FAS or partial FAS[28], excluded if IQ < 50. Recruited from a Fetal Alcohol Clinic, USA | Virtual reality game of fire safety or virtual reality game of street safety Follow-up: immediately 1-week post-intervention |
Post-intervention: children exposed to the computer game had significantly greater knowledge gain of fire safety (F(1, 31) = 18.94, p < 0.000) or street safety (F(1, 31) = 16.3 p < 0.000).
One week: children exposed to the computer game had significantly greater knowledge gain of fire safety (F(1, 31) = 15.56, p < 0.000) but not street safety (F(1, 31) = 3.13, p = 0.096). |
Kable et al, 2007[18] RCT: randomization method, allocation concealment, ITT analysis unclear; blinding (outcome assessors); follow-up 92%; sample size calculation provided. | n = 61, 3 to 10 years FAS, partial FAS, or alcohol related dysmorphology[28] Excluded if IQ < 50 or mental health problems prevented participation. Recruited: USA Fetal Alcohol Clinic and community. | Mathematics intervention (6 weeks tutoring) or a standard psycho-educational group. Follow-up: 6 weeks. |
Mathematics: The mathematics intervention group had a significantly higher gain in mathematical knowledge (F(3, 43) = 2.97, p < 0.04) and were significantly more likely to demonstrate a clinical gain compared to the psychoeducational group (58.6 vs 23.1%, χ(1, 55) = 7.1, p < 0.008) |
Loomes et al, 2008[19] Controlled trial Allocation method unclear; unblinded; follow up 97%; ITT analysis unclear; study power not provided. | n = 33, 4.2 to 11.8 years ARND, Alcohol Exposed Neuro-behavioural Disorder or Static Encephalopathy (criteria not stated) From hospital/FASD clinics, schools, community, Canada | Rehearsal training following pretest Follow-up: at average 10.6 days (range 6–21) |
Post-intervention: there was no significant difference between intervention and control groups (t = -0.49, p > 0.05)
Follow-up: the intervention group had significantly increased digit span compared to the control group (t = -1.96, p < 0.05) |
Meyer, 1998[20] Pre-post intervention, No blinding. | n = 4, primary school age, USA. FAE & learning disabled (criteria not stated) | Four minute videotape of building task |
Learning: No child could imitate the building block task |
Padgett et al, 2006[21] Pre- and post-intervention; No blinding; follow-up 100%. | n = 5, 4 to 7 years FAS, partial FAS (criteria not stated); USA Fetal Alcohol Clinic | Virtual reality game of home fire safety Follow-up:1 week |
Post-intervention: 4 children correctly sequenced cards and 3 demonstrated all steps in response to an imaginary fire. One week: 3 children correctly sequenced the cards and 5 showed all steps in response to an imaginary fire |
Social skills and social communication interventions (Table 3)
Study quality | Participants (n), age, inclusion criteria and setting | Interventions and follow-up | Outcome measures |
---|---|---|---|
O'Connor et al, 2006[22] Quasi – RCT Alternate allocation; blinding unclear; follow-up 93%; ITT analysis unclear; sample size calculation provided. | n = 100, 6 to 12 years FAS, Partial FAS or ARND[23] & social skills deficit & verbal IQ ≥ 70 Children with major sensory or motor deficits or a past diagnosis of mental retardation or pervasive developmental disorder were excluded Recruited from community, USA | CFT or delayed treatment Twelve 90-minute sessions over twelve weeks Parents attended concurrent information sessions on FASD and social skills Follow-up: 3 months |
Test of Social Skills Knowledge: The CFT group showed significant improvement in knowledge compared to the control group (F(1, 90) = 56.52, p = 0.0001). At three months, social skills knowledge was maintained (t(48) = 1.07, p < 0.29).
Social Skills Rating System Parent : social skills (F(1, 93) = 5.03, p < 0.03) and problem behaviours (F(1, 93) = 4.05, p < 0.05) significantly improved in the CFT group compared to the control group. At three months, parent reported social skills continued to improve (t(48) = 3.35, p < 0.002) and the decrease in problem behaviours was maintained (t(48) = 1.48, p < 0.15).
Social Skills Rating System Teacher : no significant difference in social skills or problem behaviours between the groups immediately post-intervention or at three months. |
Timler, 2005[25] Pre- and post-intervention Blinding unclear | n = 1, 9 years FASD[23] Recruited from a Fetal Alcohol Clinic, USA | Social communication intervention Two one-hour individual sessions per week, then four two-hour group sessions Follow-up: 6 weeks | More strategies on how to behave in a variety of social situations. Increased number of mental state verbs used. |
Vernescu, 2007[26] RCT Randomized (method unclear); allocation concealment unclear; blinding unclear; follow up 100%; ITT analysis unclear; study power not provided. | n = 20, 6 to 12 years FASD Inuit children, Canada | Attention Process Training or contact sessions Follow-up: 3 weeks |
Measures of sustained attention: children in the intervention group showed significant improvement.
Measures of non-verbal reasoning ability: children in the intervention group showed significant improvement.
Measures of executive function: no significant difference. |
Behavioural interventions (Table 3)
Discussion and Conclusion
Principal Investigator | Title | Study Type | Sample Size |
---|---|---|---|
Thomas Lock[37] | Assess the Effectiveness of Atomoxetine in Children with Fetal Alcohol Syndrome and ADD/ADHD (2006 ongoing) | RCT | 60 |
Thomas Lock[37] | Open-Label Study of the long Tern Tolerability and Safety of Atomoxetine in Children with FASD and ADD/ADHD (2006 ongoing) | Open label, uncontrolled | 60 |
Neurocognitive Habilitation for Children with Fetal Alcohol Syndrome/Alcohol Related Neurodevelopmental Disorder (2002 ongoing) | RCT | 100 | |
Fetal Alcohol Syndrome/ARND Research Consortium: Parent Child Interaction Therapy (2001 to 2005) | RCT | 100 | |
Colleen Adnams[15] | Language and Literacy therapy, Cognitive Control Therapy and Parent Group Intervention | RCT | 100 |
Intervening with Children/Adolescents with FAS/ARND: Positive Behaviour Support (2001 to 2005) | RCT | 52 | |
School-based social communication intervention provided directly to children with FAS/ARND | RCT | NA |