Guided Internet-Based Parent Training for Challenging Behavior in Children With Fetal Alcohol Spectrum Disorder (Strongest Families FASD): Study Protocol for a Randomized Controlled Trial

Karen Turner, James N Reynolds, Patrick McGrath, Patricia Lingley-Pottie, Anna Huguet, Amy Hewitt, Courtney Green, Lori Wozney, Christopher Mushquash, Nazeem Muhajarine, Andre Sourander, Heather Caughey, Jessica Roane, Karen Turner, James N Reynolds, Patrick McGrath, Patricia Lingley-Pottie, Anna Huguet, Amy Hewitt, Courtney Green, Lori Wozney, Christopher Mushquash, Nazeem Muhajarine, Andre Sourander, Heather Caughey, Jessica Roane

Abstract

Background: Fetal alcohol spectrum disorder (FASD) is a term used to encompass the full range of neurobehavioral and cognitive dysfunction that may occur as a consequence of prenatal alcohol exposure. There is relatively little research on intervention strategies that specifically target the behavioral problems of children with FASD. Availability and access to services are barriers to timely and effective care for families. The Strongest Families FASD intervention was recently adapted from the Strongest Families "Parenting the Active Child" program to include FASD-specific content delivered via an Internet-based application in conjunction with 11 telephone coaching sessions.

Objective: Our objectives are to (1) evaluate the effectiveness of Strongest Families FASD in reducing externalizing problems (primary outcome), internalizing problems, and parent distress (secondary outcomes) in children aged between 4 and 12 years diagnosed with FASD when compared to a control group with access to a static resource Web page; (2) evaluate the effectiveness of Strongest Families FASD in improving social competence (secondary outcome) in school-aged children aged between 6 and 12 diagnosed with FASD when compared with an online psychoeducation control; and (3) explore parental satisfaction with the Strongest Families FASD online parenting program.

Methods: Parents and caregivers (N=200) of children diagnosed with FASD who have significant behavioral challenges, ages 4-12, are being recruited into a 2-arm randomized trial. The trial is designed to evaluate the effectiveness of the Web-based Strongest Families FASD parenting intervention on child behavior and caregiver distress, compared to a control group receiving access to a static resource Web page (ie, a list of FASD-specific websites, readings, videos, and organizations).

Results: The primary outcome will be externalizing problems measured by the Child Behavior Checklist (CBCL). Secondary outcomes include (1) internalizing problems and (2) social competence, both measured by the CBCL; and (3) parental distress measured by the Depression Anxiety Stress Scale-21. The Client Satisfaction Questionnaire-8 (CSQ-8) and the Satisfaction Survey are completed by the intervention group at the end of session 11. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials (CONSORT) Statement.

Conclusions: It is hypothesized that the Strongest Families FASD intervention group will improve child behavior and parental distress. Caregiver satisfaction is anticipated to be positive. Advancing evidence on the effectiveness and acceptance of distance services can inform policy and adoption of eHealth programs.

Clinicaltrial: ClinicalTrials.gov NCT02210455; https://ichgcp.net/clinical-trials-registry/NCT02210455 (Archived by WebCite at http://www.webcitation.org/6bbW5BSsT).

Keywords: Strongest Families; Web-based intervention; children; disruptive behavior; eHealth; fetal alcohol spectrum disorder; neurobehavioral disorder; parenting; prenatal alcohol exposure; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: Strongest Families Institute is a not-for-profit organization delivering services to Canadian families. Dr. McGrath is co-founder and chair of the board of SFI; he derives no financial benefit from SFI. Dr. Lingley-Pottie is co-founder, president, and chief executive officer of SFI; she provides her academic and clinical consultation as an in-kind contribution to this study. Dr. Lingley-Pottie will be a co-founder of the IRIS company that is pending incorporation and may benefit financially in the future from IRIS and services sales.

Figures

Figure 1
Figure 1
Study flow.

References

    1. Sampson PD, Streissguth AP, Bookstein FL, Little RE, Clarren SK, Dehaene P, Hanson JW, Graham JM. Incidence of fetal alcohol syndrome and prevalence of alcohol-related neurodevelopmental disorder. Teratology. 1997 Nov;56(5):317–26. doi: 10.1002/(SICI)1096-9926(199711)56:5<317::AID-TERA5>;2-U.
    1. Public Health Agency of Canada . What Mothers Say: The Canadian Maternity Experiences Survey (MES) (2006-07) Ottawa, ON: Public Health Agency of Canada; 2009. [2015-10-11]. .
    1. Jones KL, Smith DF. Recognition of the fetal alcohol syndrome in early infancy. Lancet. 1973 Nov 3;302(7836):999–1001.
    1. Jones KL, Smith DW, Ulleland CN, Streissguth P. Pattern of malformation in offspring of chronic alcoholic mothers. Lancet. 1973 Jun 9;1(7815):1267–71.
    1. Lemoine P, Harousseau H, Borteyru JP, Menuet JC. Children of alcoholic parents--observed anomalies: discussion of 127 cases. Ther Drug Monit. 2003 Apr;25(2):132–6.
    1. Koren G, Nulman I, Chudley AE, Loocke C. Fetal alcohol spectrum disorder. CMAJ. 2003 Nov 25;169(11):1181–5.
    1. Health Canada Public Health Agency of Canada. Health Canada. 2014. Mar, [2015-09-03]. Evaluation of the Fetal Alcohol Spectrum Disorder (FASD) Initiative 2008-2009 to 2012-2013 .
    1. May PA, Baete A, Russo J, Elliott AJ, Blankenship J, Kalberg WO, Buckley D, Brooks M, Hasken J, Abdul-Rahman O, Adam MP, Robinson LK, Manning M, Hoyme HE. Prevalence and characteristics of fetal alcohol spectrum disorders. Pediatrics. 2014 Nov;134(5):855–66. doi: 10.1542/peds.2013-3319.
    1. Stade B, Ali A, Bennett D, Campbell D, Johnston M, Lens C, Tran S, Koren G. The burden of prenatal exposure to alcohol: Revised measurement of cost. Can J Clin Pharmacol. 2009;16(1):e91–e102.
    1. Caley LM, Winkelman T, Mariano K. Problems expressed by caregivers of children with fetal alcohol spectrum disorder. Int J Nurs Terminol Classif. 2009 Dec;20(4):181–188. doi: 10.1111/j.1744-618X.2009.01133.x.
    1. Streissguth A, Barr H, Bookstein F, Sampson P, Olson H. The Long-Term Neurocognitive Consequences of Prenatal Alcohol Exposure: A 14-Year Study. Psychological Science. 1999 May 01;10(3):186–190. doi: 10.1111/1467-9280.00131.
    1. Kodituwakku PW. A neurodevelopmental framework for the development of interventions for children with fetal alcohol spectrum disorders. Alcohol. 2010 Dec;44(7-8):717–28. doi: 10.1016/j.alcohol.2009.10.009.
    1. McGrath PJ, Lingley-Pottie P, Thurston C, MacLean C, Cunningham C, Waschbusch DA, Watters C, Stewart S, Bagnell A, Santor D, Chaplin W. Telephone-based mental health interventions for child disruptive behavior or anxiety disorders: randomized trials and overall analysis. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1162–72. doi: 10.1016/j.jaac.2011.07.013.
    1. Lingley-Pottie P, McGrath PJ, Andreou P. Barriers to mental health care: perceived delivery system differences. ANS Adv Nurs Sci. 2013 Mar;36(1):51–61. doi: 10.1097/ANS.0b013e31828077eb.
    1. Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: The participant's experience. ANS Adv Nurs Sci. 2007 Dec;30(4):353–66. doi: 10.1097/01.ANS.0000300184.94595.25.
    1. Wozney L, McGrath P, Newton A, Huguet A, Franklin M, Perri K, Leuschen K, Toombs E, Lingley-Pottie Patricia. Usability, learnability and performance evaluation of Intelligent Research and Intervention Software: A delivery platform for eHealth interventions. Health Informatics J. 2015 Jun 23; doi: 10.1177/1460458215586803.
    1. CONSORT. 2015. [2015-09-03]. Welcome to the CONSORT Website
    1. Nixon Reginald D V. Sweeney L, Erickson DB, Touyz SW. Parent-child interaction therapy: a comparison of standard and abbreviated treatments for oppositional defiant preschoolers. J Consult Clin Psychol. 2003 Apr;71(2):251–60.
    1. van de Wiel NM, Matthys W, Cohen-Kettenis P, van Engeland H. Application of the utrecht coping power program and care as usual to children with disruptive behavior disorders in outpatient clinics: A comparative study of cost and course of treatment. Behavior Therapy. 2003 Sep;34(4):421–436. doi: 10.1016/S0005-7894(03)80028-X.
    1. Achenbach T, Rescorla L. Manual for the ASEBA preschool forms & profiles: an integrated system of multi-informant assessment. Burlington, VT: ASEBA; 2000.
    1. Achenbach T, Rescorla L. Manual for the ASEBA school-age forms & profiles: an integrated system of multi-informant assessment. Burlington, VT: ASEBA; 2001.
    1. Lovibond S, Lovibond P. Manual for the Depression Anxiety Stress Scales. 2nd edition. Sydney: Psychological Foundation of Australia; 1995.
    1. Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227–39. doi: 10.1348/014466505X29657.
    1. Morawska A, Sanders MR. Self-administered behavioral family intervention for parents of toddlers: Part I. Efficacy. J Consult Clin Psychol. 2006 Feb;74(1):10–9. doi: 10.1037/0022-006X.74.1.10.
    1. Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197–207.
    1. Atkison CC, Greenfield TK. The Client Satisfaction Questionnaire-8. In: Maruish ME, editor. The Use Of Psychological Testing For Treatment Planning And Outcomes third Edition, Volume 3. Mahwah: Lawrence Erlbaum Associates; 2004. pp. 779–811.
    1. Bertrand J. Interventions for children with fetal alcohol spectrum disorders (FASDs): overview of findings for five innovative research projects. Res Dev Disabil. 2009 Oct;30(5):986–1006. doi: 10.1016/j.ridd.2009.02.003.
    1. Nash K, Rovet J, Greenbaum R, Fantus E, Nulman I, Koren G. Identifying the behavioural phenotype in Fetal Alcohol Spectrum Disorder: sensitivity, specificity and screening potential. Arch Womens Ment Health. 2006 Jul;9(4):181–6. doi: 10.1007/s00737-006-0130-3.
    1. LaFrance Michael-Anne, McLachlan Kaitlyn, Nash Kelly, Andrew Gail, Loock Christine, Oberlander Tim F, Koren Gideon, Rasmussen Carmen. Evaluation of the neurobehavioral screening tool in children with fetal alcohol spectrum disorders (FASD) J Popul Ther Clin Pharmacol. 2014;21(2):e197–210.
    1. Green CR, Roane J, Hewitt A, Muhajarine N, Mushquash C, Sourander A, Lingley-Pottie P, McGrath P, Reynolds JN. Frequent behavioural challenges in children with fetal alcohol spectrum disorder: A needs-based assessment reported by caregivers and clinicians. J Popul Ther Clin Pharmacol. 2014 Nov 17;21(3):e405–e420.
    1. Johnson DR, Young R. Toward Best Practices in Analyzing Datasets with Missing Data: Comparisons and Recommendations. J Marriage Fam. 2011;73(5):926–945. doi: 10.1111/j.1741-3737.2011.00861.x.
    1. Caley LM, Shipkey N, Winkelman T, Dunlap C, Rivera S. Evidence-based review of nursing interventions to prevent secondary disabilities in fetal alcohol spectrum disorder. Pediatr Nurs. 2006;32(2):155–62.

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