Barnes, K. J., Vogel, K. A., Beck, A. J., Schoenfeld, H. B., & Owen, S. V. (2008). Self-regulation strategies of children with emotional disturbance. Physical & Occupational Therapy In Pediatrics, 28(4), 369–387. https://doi.org/10.1080/01942630802307127

Type of Study: Pretest–posttest study with a nonequivalent control group (Quasi-experimental)
Number of Participants: 12

Population:

• Age — 9–12 years
• Race/Ethnicity — 8 White, 2 Black, and 2 Hispanic
• Gender — 10 Male and 2 Female
• Status — Participants were children in public school classrooms for emotional disturbances.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to evaluate the use of the Alert Program® within a classroom setting for children with emotional disturbances. Participants were either in the Alert Program groups or in 1 of 2 control groups. Measures utilized include the Sensory Profile, the Devereux Behavior Rating Scale (DBRS), the Self-Efficacy for Self-Regulation of School-aged Children, and the Teacher’s Perception of Student Efficacy in Self-Regulation. Results indicate that children who received the Alert Program® demonstrate a small improvement on all measures, while performance of the control group remained relatively constant or decreased. Limitations include lack of randomization of participants, small sample size, reliance on self-report measures, and lack of follow-up.

Length of controlled postintervention follow-up: None.

Bertrand, J. (2009). Interventions for children with fetal alcohol spectrum disorders (FASDs): Overview of findings for five innovative research projects. Research in Developmental Disabilities, 30(5), 98–1006. https://doi.org/10.1016/j.ridd.2009.02.003

Type of Study: Pretest–posttest study with a nonequivalent control group (Quasi-experimental)
Number of Participants: 78

Population:

• Age — 6–11 years (Mean=8.73 years)
• Race/Ethnicity — 42% Black and 37% White
• Gender — 68% Male
• Status — Participants were children in public school classrooms for emotional disturbances.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to provide a brief overview of the Alert Program® developed for individuals with fetal alcohol spectrum disorders (FASDs), and the methods and general findings of five specific intervention research studies conducted within this framework. The studies evaluated five different interventions in five diverse locations in the United States, with different segments of the FASD population. The specific aim of this study was to develop and evaluate a program of neurocognitive habilitation for children who had been in foster care or who had been adopted, and who had a diagnosis of FASD or alcohol-related neurodevelopmental disorder (ARND). Participants were grouped into 2 cohorts, an intervention group which received the Alert Program® or the control group, which received other typical services. Measures utilized include the Behavior Rating Inventory of Executive Function (BRIEF) and the Roberts Apperception Test for Children (RATC). Results indicate that children who participated in the neurocognitive habilitation program demonstrated significant improvement in executive functioning skills compared with the children in the control group. The children in the treatment group at outcome also differed from those in the control group in their response to a projective storytelling test on the RATC: children in the treatment group told fewer stories that had unrealistic solutions to problems. Limitations include lack of randomization of participants, small sample size, reliance on self-report measures, and lack of follow-up.

Length of controlled postintervention follow-up: None.

Mac Cobb, S., Fitzgerald, B., Lanigan-O'Keefe, C., Irwin, N., & Mellerick, N. (2014). Students with social, emotional, and behavioral difficulties: The Alert Program trial in post-primary schools. Journal of Occupational Therapy, Schools, & Early Intervention, 7(2), 106–119. https://doi.org/10.1080/19411243.2014.930606

Type of Study: Pretest–posttest study with a nonequivalent control group (Quasi-experimental)
Number of Participants: 84

Population:

• Age — 12–13 years
• Race/Ethnicity — 42% Black and 37% White
• Gender — 64 Male and 20 Female
• Status — Participants were students and four teachers.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
The study used the same sample as Mac Cobb et al. (2014). The purpose of the study was to report on the collaboration between teachers and occupational therapists in the Alert Program® for students with challenging behaviors. The specific aim of this study was to develop and evaluate a program of neurocognitive habilitation for children who had been in foster care or who had been adopted, and who had a diagnosis of fetal alcohol system or alcohol-related neurodevelopmental disorder (ARND). Participants were put into two trial time periods that received the Alert Program®. Trial 1 ran for one 40-minute period per week over the course of 5 weeks during the first term of post-primary school, while Trial 2 ran for one class period for 8 weeks in the second term of post-primary school. Feedback and review of Trial 1 informed the planning and delivery of Trial 2. Measures utilized include the questionnaire designed by the National Behaviour Support Service (NBSS) research team and students also completed a questionnaire on their views of the program and their interest in applying their learning (if any) to day-to-day school life. Results indicate that teachers, students, and occupational therapists reported that both content and approach engaged students who learned self-management strategies for the classroom. Limitations include lack of randomization of participants, small sample size, study utilized measures with no psychometrics, outcomes reported on the appropriateness of the intervention and not on the outcomes of the intervention, and lack of follow-up.

Length of controlled postintervention follow-up: None.

Nash, K., Stevens, S., Greenbaum, R., Weiner, J., Koren, G., & Rovet, J. (2015). Improving executive functioning in children with fetal alcohol spectrum disorders. Child Neuropsychology, 21(2), 191–209. https://doi.org/10.1080/09297049.2014.889110

Type of Study: Randomized controlled trial
Number of Participants: 25

Population:

• Age — 8–12 years (M=10.35 years)
• Race/Ethnicity — Not specified
• Gender — 14 Male and 11 Female
• Status — Participants were children with fetal alcohol spectrum disorder (FASD).

Location/Institution: Motherisk Clinic at The Hospital for Sick Children or an accredited FASD diagnostic facility in Ontario

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to examine if Alert Program for Self-Regulation® [now called Alert Program®] would produce improvements in self-regulation that would generalize to other aspects of executive function (EF), behavior, and social skills in children with fetal alcohol spectrum disorders (FASD). Participants were randomized to the Alert Program for Self-Regulation®-treatment (TXT) or Delayed Treatment Control group (DTC) / waitlist conditions. Measures utilized include the NEPSY History questionnaire, the Peabody Picture Vocabulary Test–fourth edition (PPVT-4), the Wechsler Abbreviated Scale of Intelligence (WASI), the NEPSY-II, the Test of Everyday Attention for Children (TEA-Ch), the Cambridge Neuropsychological Test Automated Battery (CANTAB), the Test of Social Cognition, the Behavior Rating Inventory of Executive Functioning (BRIEF), the Child Behavior Checklist (CBCL), the Externalizing Problems and Total Problem, and the Social Skills Improvement System (SSIS). Results indicate that at the 12-week follow-up, the TXT group displayed significant improvements in inhibitory control and social cognition. Parents of children in the TXT group reported improved behavioral and emotional regulation, as well as reduced externalizing behavior problems. These behavioral improvements, along with further improved parent-rated inhibitory control, were maintained at the 6-month follow-up. Limitations include small sample size, few of the child-administered results approached statistical significance and was unable to examine additional important factors related to outcome such as IQ, gender, and placement status which also contributed to outcome; it is possible that some treatment effects may have been washed out if more children in TXT moved into a higher age category than the DTC group over time, it is also possible that the current findings were influenced by the differential group differences at baseline in terms of the number of cases with ADHD and exposures, sample may not generalize to the larger FASD population because children were excluded with an IQ of 70 or below and had no cases with FAS.

Length of controlled postintervention follow-up: 6-months (treatment group only).

Nash, K., Stevens, S., Clairman, H., & Rovet, J. (2018). Preliminary findings that a targeted intervention leads to altered brain function in children with fetal alcohol spectrum disorder. Brain Science, 8(1), Article 7. https://doi.org/10.3390/brainsci8010007

Type of Study: Randomized controlled trial
Number of Participants: 21

Population:

• Age — 8–12 years
• Race/Ethnicity — Not specified
• Gender — Intervention 50% Male; Control: 54% Male
• Status — Participants were children with fetal alcohol system disorder (FASD).

Location/Institution: Southern Ontario

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to determine whether the Alert® Program for Self-Regulation [now called Alert Program®] improves neural functioning in other associated regions in children with fetal alcohol spectrum disorder (FASD). Participants were randomized to Alert®-treatment (TXT) or waitlist-control (WL) conditions. Participants were assessed with a Go-NoGo functional magnetic resonance imaging (fMRI) paradigm before and after training or the wait-out period. Measures utilized include the Canadian Diagnostic Guidelines system, the Diagnostic Guide for Fetal Alcohol Syndrome and Related Conditions: The 4-Digit Diagnostic Code, and the Wechsler Abbreviated Scale of Intelligence (WASI). Results indicate that groups initially performed equivalently and showed no fMRI differences. At posttest, TXT outperformed WL on NoGo trials, while fMRI in uncorrected results with a small-volume correction showed less activation in prefrontal, temporal, and cingulate regions. Groups also demonstrated different patterns of change over time reflecting reduced signal at posttest in selective prefrontal and parietal regions in TXT; and increased in WL. In light of previous evidence indicating TXT at posttest perform similar to nonexposed children on the Go-NoGo fMRI paradigm, the findings suggest Alert ® does improve functional integrity in the neural circuitry for behavioral regulation in children with FASD. Limitations include small sample size, did not examine the impact of other prenatal exposures (e.g., nicotine) on results, did not monitor Alert ® effects outside the lab to see if children who changed most were ones whose parents applied the therapy at home, and lack of follow-up.

Length of controlled postintervention follow-up: None.

The following studies were not included in rating Alert Program® on the Scientific Rating Scale...

Mac Cobb, S., Fitzgerald, B. & Lanigan-O'Keefe, C. (2014). The Alert Program for self-management of behaviour in second level schools: results of phase 1 of a pilot study. Emotional and Behavioural Difficulties, 19(4), 410–425. https://doi.org/10.1080/13632752.2014.903593

This summary reports on Phase 1 of the Alert Program® with a challenging class groups of students as part of the evidence-informed practice of the National Behaviour Support Service (NBSS). The purpose of the study was to develop and evaluate a program of neurocognitive habilitation for children who had been in foster care or who had been adopted, and who had a diagnosis of fetal alcohol syndrome or alcohol-related neurodevelopmental disorder (ARND). Measures utilized include a questionnaire designed by the NBSS research team. Students also completed a questionnaire on their views of the program and their interest in applying their learning (if any) to day-to-day school life. Results indicate that teachers reported that the content and class management strategies were appropriate. Students gained an understanding of their behavior and identified self-management strategies for use in the class. They recommended that all teachers working with the class group should be familiar with the language and techniques of the program to reinforce learning. Feedback from 85% (72) of students confirmed that the learning tasks were considered by the majority to be enjoyable and relevant. The group of students perceived to be the most challenging gave the most positive scores, and 100% of these indicated their intention to use their new self-management strategies in class. The results led to Phase 2 of the pilot in which teachers took the lead role, with occupational therapist support, in a national pilot in 16 schools in areas of social disadvantage. Limitations include lack of randomization of participants, small sample size, study utilized measures with no psychometrics, outcomes reported on the appropriateness of the intervention and not on the outcomes of the intervention, and lack of follow-up. Note: This article was not used for rating Alert Program in the Fetal Alcohol Spectrum Disorders (FASDs) Interventions (Child & Adolescent) topic area since only part of the intervention was evaluated in the article.