Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial

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1 research-article2016 JCTXXX / JDR Cliical & Traslatioal ResearchCogitive Behavioral Therapy for Childre with Detal Axiety JDR Cliical & Traslatioal Research October 2016 Origial Report: Epidemiologic Research Cogitive Behavioral Therapy for Childre with Detal Axiety: A Radomized Cotrolled Trial S. Shahavaz 1, E. Hedma 2, M. Gridefjord 1,3, L. Reuterskiöld 4, ad G. Dahllöf 1 Abstract: Detal axiety affects approximately 9% of childre ad is associated with poor oral health, pai, ad psychosocial problems. The objective of this study was to ivestigate the efficacy of cogitive behavioral therapy (CBT) for childre with detal axiety i specialist pediatric detistry. The study used a parallel-group superiority radomized cotrolled trial desig. The primary outcome measure was the behavioral avoidace test; assessors were blid to treatmet allocatio. Participats were 8 boys ad 22 girls 7 to 18 y old (mea ± SD, 10 ± 3.1). Childre fulfillig the diagostic criteria for detal axiety were radomized to CBT ( = 13) or treatmet as usual ( = 17), such as various sedatio methods. Psychologists provided 10 h of CBT based o a treatmet maual. Treatmets were coducted i a aturalistic real-world cliical settig. Assessmets were coducted before the treatmet, 3 mo after the start of treatmet, ad at 1-y follow-up. The aalyses of the primary outcome measure by repeated-measures aalysis of variace ad idepedet t test showed that childre receivig CBT made superior, statistically sigificat improvemets at follow-up (16.8 ± 2.4) compared with treatmet as usual (11.4 ± 3.1, P < 0.01). A large betweegroup effect size (Cohe s d = 1.9) was foud. Followig treatmet, 73% of those i the CBT group maaged all stages of the detal procedures icluded i the behavioral avoidace test compared with 13% i the treatmetas-usual group. Furthermore, 91% i the CBT group compared with 25% i the treatmet-as-usual group o loger met the diagostic criteria for detal axiety at the 1-y follow-up accordig to the secodary outcome measure. Measures of detal axiety ad selfefficacy showed larger improvemets i the CBT group compared with cotrols. We coclude that CBT is a efficacious treatmet for childre ad adolescets with detal axiety ad should be made accessible i pediatric detistry (CliicalTrials.gov: NCT ). Kowledge trasfer statemet: The results of this study ca be used by decisio makers ad cliicias whe plaig to implemet evidece-based treatmet i pediatric detistry ad give childre ad adolescets access to methods for treatig detal axiety. The results ca also be used by parets of childre with detal axiety whe askig detists to cooperate with psychologists usig cogitive behavioral therapy. Keywords: pediatric detistry, cliical psychology, self-efficacy, evidece-based detistry, detal fear, behavioral problem Itroductio Detal axiety affects approximately 9% of childre ad adolescets (Kligberg ad Broberg 2007). The fourth editio text revisio of the Diagostic ad Statistical Maual of Metal Disorders (DSM-IV-TR) classifies detal axiety as a form of specific phobia (America Psychiatric Associatio [APA] 2000). The DOI: / Departmet of Detal Medicie, Divisio of Pediatric Detistry, Karoliska Istitutet, Stockholm, Swede; 2 Departmet of Cliical Neurosciece, Karoliska Istitutet, Stockholm, Swede; 3 Departmet of Pediatric Detistry, Eastma Istitutet, Public Detal Service, Stockholm, Swede; 4 Departmet of Psychology, Stockholm Uiversity, Stockholm, Swede. Correspodig author: S. Shahavaz, Departmet of Detal Medicie, Divisio of Pediatric Detistry, Karoliska Istitutet, Box , Huddige, Swede. shervi.shahavaz@ki.se A supplemetal appedix to this article is published electroically oly at Iteratioal & America Associatios for Detal Research

2 Vol. 1 Issue 3 Cogitive Behavioral Therapy for Childre with Detal Axiety coditio is characterized by marked fear ad axiety respose whe the idividual is exposed to detal care. It leads to itese distress ad/or avoidace (APA 2000). Detal axiety ofte maifests itself durig childhood ad is associated with poor oral health such as utreated caries, missig teeth, or periodotal problems (Crego et al. 2014). These egative cosequeces also iclude sese of embarrassmet related to poor oral health, reduced self-cofidece, ad icreased absece from work (Wide Boma et al. 2013). Pediatric detistry commoly employs several methods to deal with detal axiety, which iclude tell-show-do, premedicatio with midazolam, itrous oxide sedatio, ad geeral aesthesia (Kligberg et al. 2010; Roberts et al. 2010). A recet systematic review, however, reported that the quality of the evidece supportig these commo methods i pediatric detistry is low or very low (Mejàre et al. 2015). So it is ucertai whether these strategies ifluece behavioral problems sufficietly. Cogitive behavioral therapy (CBT) has bee show to be effective for treatmet of several specific phobias (Olledick ad Kig 1998; Atoy ad Barlow 2002). Moderate to large treatmet effects for adults with detal axiety have bee observed i radomized trials (Kvale et al. 2004; Haukebø et al. 2008). CBT is a structured ad brief psychological treatmet based o a combiatio of psychoeducatio, exposure, ad homework exercises (Öst ad Clark 2013). I qualitative studies, childre ad parets have reported positive experieces with CBT ad have foud CBT to improve their ability to deal with detal axiety ad other specific phobias (Svesso et al. 2002; Shahavaz et al. 2015). The literature stresses the eed for further research o the applicatio of CBT i pediatric detistry (Porritt et al. 2012). Materials ad Methods Participats A detal assistat called all parets whose childre had bee referred to 2 pediatric detal cliics i Stockholm from Jauary 2013 through March 2014 for detal axiety or behavioral maagemet problems to ivite them to participate i the study. Iformatio about the study was set to both private ad public detal service cliics i Stockholm ad published o the official web page of the Departmet of Detal Medicie at Karoliska Istitutet, ad local ewspapers published articles about the trial. Self-referral was ot allowed, so all potetial participats were referred from a detist i geeral detistry. Participats had to meet the followig iclusio criteria: 1) the patiet ad all primary caregivers agreed to participate i the study, 2) the patiet had a pricipal diagosis of specific phobia (detal axiety or itraoral ijectio phobia) accordig to the DSM-IV-TR, 3) o other psychiatric or developmetally related diagoses cosidered to be the primary diagosis, 4) the patiet was ot receivig cocurret psychological treatmets ad did ot have appoitmets for psychological examiatio elsewhere, ad 5) the patiet eeded detal care but ot emergecy care. I additio to the eligibility criteria above, parets ad childre eeded to fulfill some practical requiremets for participatio. They had to have 1) the time ad opportuity to take time off from school to go to a specialist cliic for treatmet, 2) a stable livig situatio with o family crisis such as a ogoig divorce, 3) o serious somatic illess that would disrupt daily life ad hider participatio i the study, 4) access to a computer at home or i a public place for aswerig the olie questioaires related to the study, ad 5) motivatio to participate i the treatmet. Itervetios We based this trial o CBT models for treatig axiety disorders ad specific phobias (Lyeham et al. 2003; Beidas et al. 2010; Davis et al. 2012). Our research team developed the therapist maual, 40 pages i total. The patiets, parets, ad therapists met for 10 h of CBT at 2 pediatric detal cliics i Stockholm. Sessios 1 to 2, 3 to 4, ad 5 to 6 were offered durig the first 3 wk. Double sessios were offered at the same day with 15 mi of rest betwee the sessios. Sessios 7 to 10 were offered durig the remaiig 8 wk (1 sessio/h every other week). The cetral compoets of these sessios were behavioral aalyses, psychoeducatio, paret educatio, exposure to detal procedures both i vivo ad i films, relaxatio techiques, procedural pai maagemet iformatio, ad cogitive restructurig (Table 1). Patiets uderwet exposures by watchig short films showig a child goig through various detal procedures durig the sessios with psychologist. Childre ad parets had access to detal tools ad materials such as a probe, cotto balls, topical aesthetic, a spiral-shaped suctio ozzle, ad eedle to practice at home. The maual ad films are available i Swedish ad ca be obtaied by ig the correspodig author. Treatmet was adapted to the child s age, ad the youger the child, the more paretal support ad behavioral techiques (less cogitive itervetios). The therapists coductig the treatmet were 3 licesed psychologists with at least 5 y of psychology traiig at uiversity ad 1 y of cliical traiig uder supervisio. All therapists had a CBT qualificatio ad betwee 6 mo ad 8 y of experiece deliverig CBT i pediatric detistry. To icrease treatmet adherece ad therapist competece, the psychologist with 8 y of experiece gave weekly supervisio to the other 2 therapists durig the study. Treatmet fidelity was cotiuously discussed durig these supervisios. The therapists were also give access to checklists for each sessio (maitaiig the major feature of the sessio). The total umber of detal visits varied depedig o the patiet s detal treatmet eeds. Detal treatmet bega earliest after sessio 6 i the CBT group. The treatmet as usual cosisted of methods such as, tellshow-do, distractio, premedicatio with midazolam, itrous oxide sedatio, 235

3 JDR Cliical & Traslatioal Research October 2016 Table 1. Descriptio of Sessio Cotet. 1. Behavior aalysis, psychoeducatio (mechaisms of axiety ad cogitive behavioral therapy), itroductio, ad home assigmets 2. Paret educatio (parets relatio to detistry ad fear, reiforcemet/rewardig strategies, how to ehace childre s self-efficacy) 3. Exposure list, goal settig, exposure, ad cotrolled breathig 4. Exposure ad cogitive restructurig 5. Exposure ad pai maagemet educatio, relaxatio, ad midfuless traiig 6. Exposure, detistry-related commuicatio ad social skill traiig, assertiveess, maagig safety behavior, ad preparatio for meetig with detal staff 7. Exposure, evaluatio of meetig with detal staff, preparatio of detal treatmet ad repetitio of goals, ad relaxatio ad breathig techiques 8. Exposure ad copig strategies ad evaluatio of exposure/treatmet with detist 9. Evaluatio of detal treatmet experieces ad exposure ad repetitio 10. Evaluatio of detal treatmet experieces, relapse prevetio pla, ad diploma ad geeral aesthesia. Appedix A (available olie) describes treatmet as usual i more detail. Objective The objective of this study is to test the hypothesis that CBT for childre ad adolescets with detal axiety is more efficacious tha treatmet as usual (behavioral maagemet ad sedatio techiques) for icreasig a child s ability to udergo detal procedures ad reducig detal axiety. Outcomes Primary outcome measure The Behavioral Avoidace Test (BAT) was used i a earlier study of CBT for adults with detal axiety (Haukebø et al. 2008). The versio of the BAT used i this study was adapted to pediatric detistry ad more stadardized tha the earlier versio. Durig the test, a detist would expose participats to a potetial maximum of 18 hierarchically orgaized detal cliical situatios such as eterig the detal treatmet room, opeig the mouth, ijectio of local aesthesia (a quarter of a cartridge), ad drillig (a small piece of composite was etched to the buccal surface of a madibular molar, which made it possible to simulate drillig i a tooth. This piece of composite was thereafter removed). Childre were istructed by the detist to try their best to complete the list of differet detistry procedures but were also give the possibility to discotiue at ay momet (without beig persuaded by parets or detists to cotiue). The score for each child was sum of stages from 0 (ot eterig the detist room) to 18 (maagig the drill), 1 poit for each stage. Measuremet fidelity was esured through detailed test maual ad assessor traiig. A psychologist moitored ad maitaied the measuremet fidelity by cotiuous discussios with detists ad detal assistats coductig the BAT. The Swedish BAT ad its maual are available o request. The assessmets were coducted before the treatmet, 3 mo after the treatmet, ad at 1-y follow-up. Other Outcome Measures The secodary outcome measure was the presece or absece of detal axiety as measured i the Structured Cliical Iterview for Detal Axiety (SCI-DA). The iterview format was based o the specific phobia sectio of the Developmet ad Well-Beig Assessmet (DAWBA) with additioal questios related to detistry. The reliability of DAWBA expert diagoses has bee reported as satisfactory (Aebi et al. 2012). The other outcome measures were the child (CFSS-DS-C) ad paret (CFSS- DS-P) versios of the Childre s Fear Survey Schedule Detal Subscale (CFSS-DS). The CFSS-DS has high testretest reliability ad validity (Kligberg 1994). The CFSS-DS cosists of 15 items (scale 1 5, from o fear to high fear) measurig the degree of fear associated with various situatios i detal ad medical care ad iteractios with people ufamiliar to the child. We also used the Self-Efficacy Questioaire for Specific Phobias (SEQ-SP). It cosists of 14 questios (scale 1 5, from low to high self-efficacy) assessig the level of self-efficacy, defied as people s belief i their ability to accomplish give achievemets (Badura 1977). Prelimiary evidece for the reliability ad validity of the SEQ-SP has bee demostrated by Flatt ad Kig (2009). Sample Size A detal assistat called the parets of 182 patiets to recruit them to the study. The parets of 67 expressed iterest i their child participatig. Of these, 30 fulfilled the iclusio criteria ad were radomized (Fig.). The sample size ad power of this study are comparable to other studies of CBT ad detal axiety (Kvale et al. 2004; Haukebø et al. 2008). Radomizatio We used urestricted radomizatio. A exteral perso, ot ivolved i the study, radomly assiged the participats to the treatmet coditios accordig to a true radomizatio list that was geerated at We allocated patiets to the itervetio groups oly after decidig whether to iclude the patiet i the study. Participats were radomly assiged to CBT ( = 13) or treatmet as usual ( = 17). Participats were 8 boys ad 22 girls 7 to 18 y old (mea ± SD, 10 ± 3.1). Table 2 presets the sociodemographic ad cliical characteristics of the participats i the itervetio groups. 236

4 Vol. 1 Issue 3 Cogitive Behavioral Therapy for Childre with Detal Axiety Table 2. Baselie Demographic ad Cliical Characteristics. Variable CBT ( = 13) TAU ( = 17) Age, mea ± SD, y 10 ± 3 10 ± 3 Sex (female), % Paretal or siblig detal fear, % Child bor i Swede, % Paret 1 bor i Swede, % Paret 2 bor i Swede, % Paret 1 employed, % Paret 2 employed, % Cliical characteristics Comorbidity, % 8 12 Duratio of detal axiety, mea ± SD, y 4 ± ± 2.9 Itraoral ijectio as mai fear, % Need for restoratios, % Number of decayed surfaces, mea ± SD Referred for extractio, % Number of extractios, mea ± SD Blidig The outcome assessors (for the primary outcome) were blid to the assiged treatmet. At follow-up, to aalyze the itegrity of the blidig, we asked detists to guess the allocatio status of each participat i cojuctio with admiisterig the BAT. We also asked detists whether they had leared the treatmet status of ay of the participats before they met them. Moreover, whe schedulig the BAT, we istructed all participats ad their parets ot to metio which itervetio they had received. Procedure All participats ad parets (oe paret if there was oly oe primary caregiver) provided writte iformed coset. The laguage of the study ad all outcome ± ± ± ± 0.5 Comorbidity diagoses are specific phobia for dogs i the CBT group ad attetio-deficit/hyperactivity disorder ad social axiety i the TAU group. CBT, cogitive behavioral therapy; TAU, treatmet as usual. measures was Swedish. We coducted assessmets for all the outcome measures before treatmet, after 3 mo of treatmet, ad at a 1-y follow-up. Except for the BAT ad SCI-DA, all assessmets used olie questioaires. Parets ad childre (older tha age 11 y) were give access to the DAWBA o the Iteret by persoalized password (www. dawba.et). The cliical psychologist determied whether the patiet met the iclusio criteria based o the face-toface SCI-DA ad DAWBA. Both the child ad paret were iterviewed usig the SCI-DA. Three licesed psychologists with traiig i admiisterig the SCI-DA ad the DAWBA made the cliical assessmets. Durig the recruitmet period, these assessors received supervisio o a regular basis from a expert i assessmet of axiety disorders i childre ad adolescets. The Regioal Ethics Review Board i Stockholm approved the study, ad the trial was registered at CliicalTrials.gov (NCT ). Statistical Aalyses Aalyses used SPSS versio 22 (SPSS, Ic.). Data for the primary outcome measure, BAT, ad other cotiuous measures, CFSS-DS ad SEQ-SP, were aalyzed by repeated-measures aalysis of variace (ANOVA). Idepedet t tests were used to compare the CBT ad cotrol group before treatmet, after treatmet, ad at the 1-y follow-up. Furthermore, paired t tests were used for the primary outcome measure ad other cotiuous measures to aalyze the withi-group effects by comparig chages from before the treatmet to after treatmet, before treatmet to the 1-y follow-up, ad after treatmet to the 1-y follow-up i each group. Cohe s d based o pooled stadard deviatios was used as a measure of effect size. The evaluatio of the secodary outcome measure, SCI-DA (frequecy of diagosis-free patiets i each group), ad the cliically sigificat improvemet for CBT ad cotrols (betwee-group differeces) were coducted by the chi-squared test or Fisher s exact test. Withi-group differeces i the secodary outcome measure (umber of diagosis-free childre) were aalyzed by Cochra s Q test ad McNemar s test, explorig if there were withi-group differeces i the dichotomous depedet variable (before treatmet to after, before treatmet to the 1-y follow-up, ad after treatmet to the 1-y follow-up). Results Participat Flow ad Attritio The Figure shows the flow of participats through the trial. Two participats i the CBT group dropped out after radomizatio ad before receivig treatmet. I the first case, the paret reported that the child had received treatmet durig travel abroad due to a acute eed for treatmet ad 237

5 JDR Cliical & Traslatioal Research October 2016 Figure. Flowchart showig patiet selectio, radomizatio, dropout, ad follow-up assessmets. required o further detal treatmet. I the secod case, a paret got a ew job ad stated the child could ot participate because the paret had difficulties takig time off to visit the cliic durig office hours. Also, despite several remiders, 1 paret ad child i the treatmet-as-usual group did ot complete the CFSS-DS ad SEQ-SP after treatmet, ad aother participat i the cotrol group did ot show up for the 1-y follow-up visit ad measuremet. Furthermore, paretal outcome for 1 teeager amog cotrols could ot be obtaied. Oe youg participat (CBT group) had major difficulties uderstadig ad aswerig the selfefficacy questioaire, ad we made the decisio i cosultatio with the assessor ot to iclude scores for the SEQ-SP. All other patiets i both groups completed their treatmets ad measuremets. Iformatio from detal records showed that the ecessary detal treatmet eeds for participats were met i both itervetio groups. I the CBT group, 9% of participats (1 perso) eeded adjuctive midazolam sedatio. I the treatmet-as-usual group, 50% of participats were treated usig itrous oxide, midazolam, or geeral aesthesia. Primary Outcome (Cliicia Admiistered) There was a statistically sigificat iteractio of group ad time i the ability to cope with detal procedures accordig to the BAT, the primary outcome measure, F (2, 50) = 5.78, 238

6 Vol. 1 Issue 3 Cogitive Behavioral Therapy for Childre with Detal Axiety Table 3. Efficacy of Cogitive Behavioral Therapy for Childre with Detal Axiety. Measures (Scale Rage), Group, ad Participats Before Treatmet, Mea (SD) After Treatmet, Mea (SD) 1-y Follow-up, Mea (SD) F Value (df ) BAT (0 18) CBT TAU 7.0 (4.1) (3.8) (4.1)*** (2.1) (2.4)** 11 G: 12.1 (1)** 11.4 (3.1) 16 T: 46.9 (2)**** I: 5.8 (2)*** CFSS-DS-C (15 75) CBT 38.3 (11.6) (6.5)* (10.0)** 11 TAU 42.1 (9.5) 33.3 (9.7) 33.8 (7.6) G: 15.4 (1)*** T: 20.5 (2.48)**** I: 0.96 (2.48) CFSS-DS-P (15 75) CBT TAU 34.6 (7.6)* (8.0) (6.9)*** (8.2) (4.9)** 11 G: 22.9 (1)**** 30.7 (7.6) 15 T: 28.9 (2)**** I: 1.7 (2) SEQ-SP (0 70) CBT TAU 35.0 (10.7) (9.8) (8.3)** (10.4) (7.8)** 10 G: 31.5 (1)**** 32.6 (11.9) 16 T: 8.5 (2)** I: 3.1 (2) BAT, behavior avoidace test; CBT, cogitive behavioral therapy; CFSS-DS-C, Child Fear Survey Schedule Child Versio; CFSS-DS-P, Child Fear Survey Schedule Paretal Versio; G, group; I, iteractio; SEQ-SP, Self-Efficacy Questioaire for Specific Phobias; T, time; TAU, treatmet as usual. *P < **P ***P < ****P < Note that sigificace after treatmet ad at the 1-y follow-up is based o aalyses with idepedet t tests. P = 0.006, partial η 2 = The mea values of ability to maage detal procedures accordig to the BAT idicate that childre ad adolescets improved more i the CBT group tha cotrols (Table 3). Aalyses of BAT results showed that childre receivig CBT made superior, statistically sigificat improvemets compared with cotrols both after the treatmet (mea ± SD, 15.2 ± 4.1 for the CBT ad 11.1 ± 2.1 for the cotrols) ad at the 1-y follow-up (16.8 ± 2.4 for CBT ad 11.4 ± 3.1 for cotrols). There was also statistically sigificat withi-group improvemet i the BAT (Table 4). Effect size A large betwee-group effect size (Cohe s d = 1.4 after the treatmet ad 1.9 at the 1-y follow-up) was foud. Eve the withi-group effect sizes were large (Table 4). The maximum value of 18 o the BAT meas that patiets ca maage ijectio with local aesthesia ad drillig i a composite placed o a tooth, procedures highly sigificat i a cliical cotext. Therefore, to calculate the cliical sigificace, we dichotomized the BAT values based o the cutoff value of 18. I the CBT group, 64% maaged all stages i the BAT after treatmet compared with 6% i the treatmet-asusual group. Correspodig frequecies at the 1-y follow-up were 73% ad 13%, respectively. We foud statistically sigificat improvemet i favor of CBT at both the after-treatmet assessmet (P = 0.002) ad 1-y follow-up (P = 0.003). Assessmet of maskig We foud o sigificat associatio betwee the assessors guess ad the actual treatmet allocatio whe 239

7 JDR Cliical & Traslatioal Research October 2016 Table 4. Effect Sizes of Cogitive Behavioral Therapy ad Treatmet as Usual for Detal Axiety. Betwee-Group Effect Sizes Cohe s d (95% Cofidece Iterval) Withi-Group Effect Sizes Cohe s d (95% Cofidece Iterval) Measures (Scale Rage) After Treatmet 1-y Follow-up Before Treatmet to after Treatmet Before Treatmet to 1-y Follow-up After Treatmet to 1-y Follow-up BAT 1.4 (0.5 to 2.25) 1.9 (0.95 to 2.9) CBT 2.0 (1.1 to 2.9)**** 2.9 (0.8 to 5.0)**** 0.5 (0.3 to 1.3) TAU 1.3 (0.3 to 2.3)** 1.2 (0.4 to 2.0)*** 0.1 ( 0.5 to 0.8) CFSS-DS-C 1.4 (0.5 to 2.3) 1.0 (0.2 to 1.9) CBT 1.8 (0.9 to 2.8)**** 1.3 (0.3 to 2.3)*** 0.4 ( 1.4 to 0.5) TAU 0.9 (0.2 to 1.7)** 1.0 (0.2 to 1.7)** 0.1 ( 0.7 to 0.5) CFSS-DS-P 1.7 (0.7 to 2.7) 1.5 (0.6 to 2.5) CBT 1.8 (0.7 to 3.0)**** 2.2 (1.1 to 3.3)**** 0.1 ( 0.5 to 0.8) TAU 0.8 (0.3 to 1.3)*** 1.3 (0.3 to 2.3)*** 0.5 ( 0.3 to 1.2) SEQ-SP 2.2 (1.1 to 3.3) 1.7 (0.7 to 2.6) CBT 1.9 (1.3 to 2.5)**** 1.6 (0.2 to 3.1)** 0.3 ( 1.5 to 0.8) TAU 0.3 ( 0.4 to 0.9) 0.3 ( 0.4 to 1.1) 0.1 ( 0.7 to 0.8) BAT, behavior avoidace test; CBT, cogitive behavioral therapy; CFSS-DS-C, Child Fear Survey Schedule Child Versio; CFSS-DS-P, Child Fear Survey Schedule Paretal Versio; SEQ-SP, Self-Efficacy Questioaire for Specific Phobias; TAU, treatmet as usual. **P ***P < ****P < Note that sigificace is based o aalyses with paired t tests. evaluatig the blided behavioral avoidace test at follow-up. Moreover, all detists reported that they were uaware of the allocatio status of the patiets before testig. Secodary Outcomes (Cliicia Admiistered) At the after-treatmet assessmet ad 1-y follow-up, there was a statistically sigificat betwee-group differece i the proportio of participats meetig the diagostic criteria for detal axiety accordig to the SCI-DA. After treatmet, 64% of participats i the CBT group o loger met the diagostic criteria for detal axiety compared with 18% i the treatmet-as-usual group. The correspodig chages at 1-y follow-up were 91% ad 25%. The associatio betwee treatmet ad frequecy of diagosis-free patiets i the CBT group was statistically sigificat at the aftertreatmet assessmet (P = 0.02) ad 1-y follow-up (P = 0.001). The statistically sigificat ad high percetage of participats i the CBT group ot meetig the diagostic criteria for detal axiety at the after-treatmet assessmet ad follow-up measuremet ca be cosidered evidece of cliically sigificat improvemet. Other Outcome Measures (Self- Reported ad Paret Reported) Aalyses of the iteractio betwee the itervetio ad time i the CFSS- DS-C, CFSS-DS-P, ad SEQ-SP usig repeated-measures ANOVA showed o statistically sigificat iteractio (Table 3). However, we observed statistically sigificat betwee-group differeces favorig CBT (reductio of fear ad icreased self-efficacy) at both the aftertreatmet assessmet ad 1-y follow-up for all 3 measures. The withi-group improvemets were sigificat for the CFSS-DS (C&P) i both groups but oly sigificat i the CBT group for SEQ-SP. Effect size Large betwee-group effect sizes were observed for these measures. However, the withi-group effect size for the SEQ-SP i the cotrol group was low (Table 4). To be able to evaluate a patiet-specific ad cliically sigificat fear, we chose either item 3, which measures ijectio fear, or item 8, which measures fear of drill for each participat ad paret o the CFSS-DS. We selected whichever of these items the patiet rated highest at the first assessmet before the treatmet. We desigated a CFSS-DS score of 2 (little afraid) or less o a scale of 1 to 5 to idicate the cutoff for cliically sigificat improvemet, ad we categorized values betwee 3 ad 5 240

8 Vol. 1 Issue 3 Cogitive Behavioral Therapy for Childre with Detal Axiety as idicatig o improvemet. We the dichotomized the results accordig to the cutoff value. There was a statistically sigificat associatio betwee treatmet ad item values i favor of the CBT group after treatmet for the CFSS- DS-C (P = 0.010) ad the CFSS-DS-P (P = 0.020). Results for sigificat improvemet at the 1-y follow-up were similar to after-treatmet assessmet results (P = 0.001, P = 0.043). I the CBT group, 73% of childre showed a cliical improvemet compared with oly 6% of childre i the cotrol group after treatmet accordig to the child ratigs ad 81% compared with 30% accordig to the paret ratigs. Adverse Effects Childre ad their parets i the CBT group were asked about their treatmet experieces by a short qualitative iterview after the treatmet, ad they did ot report ay adverse evets. No adverse effects were spotaeously reported by the detal team or the psychologists who were part of the study either. Discussio Mai Fidigs CBT is a efficacious treatmet for childre ad adolescets with detal axiety accordig to our fidigs. CBT resulted i superior psychological treatmet improvemets compared with treatmet as usual. At the 1-y follow-up, 73% of those i the CBT group maaged all stages of the behavior avoidace test compared with 13% i the cotrol group (icludig receivig local aesthesia ad drillig). Furthermore, 91% i the CBT group compared with 25% i the cotrol group o loger met the diagostic criteria for detal axiety at the 1-y follow-up. We chose a 1-y follow-up period because it is commo i both CBT studies ad i detistry (1-y recall iterval). Effect sizes for both the CBT ad cotrols regardig the BAT ad CFSS-DS outcome measures were large, idicatig that we achieved our aim of havig treatmet as usual as a active cotrol group. The CBT group, however, showed a larger effect size tha the cotrol group. Treatmet effects were maitaied at the 1-y follow-up. Oe iterestig fidig was that the effect size related to self-efficacy was high for the CBT group ad low for the cotrol group. This, i additio to a sigificat icrease i the SEQ-SP from before treatmet to the after-treatmet assessmet ad 1-y follow-up see oly i the CBT group, could support studies that suggest self-efficacy as a mechaism of chage i CBT (Gallagher et al. 2013). Fidigs i the preset study are cosistet with results of CBT ad its efficiecy i treatig childre ad adolescets with axiety disorders (I-Albo ad Scheider 2007; Davis et al. 2012). Accordig to repeated-measures ANOVA, iteractio effects of time ad group were osigificat for several secodary outcomes. This could be due to the absece of improvemet from the after-treatmet assessmet to the 1-y follow-up for the CFSS-DS (C & P) ad SEQ-SP. We did ot offer patiets booster sessios (sice the cotrols could ot get this itervetio, ad it would disrupt the radomized cotrolled trial desig), which could explai the lack of improvemet betwee the after-treatmet assessmet ad the 1-y follow-up. Most childre ad adolescets i our study stated that itraoral ijectio was oe of their mai fears i detistry. This made the CFSS-DS iappropriate as the primary outcome measure, sice it cotais oly 1 item measurig ijectio fear, ad the literature suggests that the CFSS-DS caot measure chages i the degree of ijectio fear properly (Lopes et al. 2013). Other reasos for choosig the BAT as our primary outcome icluded its greater capacity to reflect the child s actual performace i detistry ad that it ca be measured by a blided assessor, which icreases accuracy ad reduces detectio bias. The ecessary detal treatmet eeds of participats i both itervetio groups were met accordig to iformatio from detal records. This suggest that treatmet-as-usual methods such as sedatio techiques make it possible for childre with detal axiety to udergo detal treatmet i specialist pediatric detistry. Our study shows that these methods i cotrast to CBT caot sufficietly ifluece the behavioral ad emotioal variables importat for cliically sigificat ad sustaiable psychological chage. Limitatios This study is limited by the umber of radomized patiets, which may reduce the represetativeess of the sample ad create difficulties i geeralizig the results. The reaso for the small sample size i this study was difficulty i recruitig ad fidig participats who fulfilled the iclusio criteria ad were willig to participate i a psychological scietific study. The idividuals we ivited to participate i the study were a mixed group of referred patiets (from geeral detists) that icluded patiets with behavior maagemet problems, detal fear, ad primary psychiatric diagoses other tha detal axiety. Some were receivig ogoig psychological treatmet elsewhere, which led to their exclusio. Our iclusio criteria were, perhaps, too strict. But, sice this is the first radomized cotrolled trial of CBT i pediatric detistry, we aimed for high iteral validity rather tha high exteral validity. The literature recogizes the difficulties i recruitig participats with a specific phobia diagosis i geeral ad with detal axiety i particular (Atoy ad Barlow 2002; Wide Boma et al. 2014). Aother limitatio is related to the use of treatmet as usual as the cotrol group. This meat that we could ot match the umber of detal visits i our itervetio groups. Implicatios As stated i a recet meta-aalysis, it is ucertai if methods commoly used i pediatric detistry to maage detal axiety ca ifluece behavioral problems sufficietly (Mejàre et al. 2015). 241

9 JDR Cliical & Traslatioal Research October 2016 The results of this study show that it is feasible to coduct CBT for childre ad adolescets with detal axiety i detistry. The treatmet approach is effective i icreasig a patiet s ability to maage detal procedures, icrease self-efficacy, ad reduce fear related to specific detal procedures. Stregths of this study iclude its radomizatio, maual-based treatmet, stadardized masked BAT, ad 4-fold measuremet (child, paret, detist, ad psychologist assessmets). Furthermore, the trial was coducted i a aturalistic realworld cliical settig, which suggests that the results could be a importat ad promisig treatmet alterative for childre ad adolescets with detal axiety ad should be made accessible for this patiet group. Nevertheless, there is a eed for more radomized cotrolled trials of CBT for childre ad adolescets i detal settigs. There is also a eed to modify ad adapt CBT for detal orgaizatios that do ot have access to psychologists ad for groups of patiets i pediatric detistry who caot beefit from the traditioal faceto-face versio of the CBT treatmet (e.g., patiets ad parets who caot take time off from work or school to visit a psychologist). Studies examiig the efficiecy of shorter CBT itervetios such as 1-sessio treatmet would also be importat to coduct i pediatric detistry (Haukebø et al. 2008). Author Cotributios S. Shahavaz, cotributed to coceptio, desig, ad data acquisitio, drafted ad critically revised the mauscript; E. Hedma, cotributed to coceptio, desig, data aalysis, ad iterpretatio, critically revised the mauscript; M. Gridefjord, cotributed to coceptio, desig, ad data acquisitio, critically revised the mauscript; L. Reuterskiöld ad G. Dahllöf, cotributed to coceptio, desig, data acquisitio, aalysis, ad iterpretatio, critically revised the mauscript. All authors gave fial approval ad agree to be accoutable for all aspects of the work. Ackowledgmet The authors ackowledge the followig: childre ad their parets for participatig i this project; psychologists Tove Hasselblad ad Sara Ytterbrik, as well as detal assistat Kataria Edetorp Eriksso, for their help coordiatig the research project ad treatig patiets; the detists at the pediatric specialist cliics who coducted the behavioral avoidace tests ad treated patiets; ad Mayflower Charity Foudatio for Childre ad Karoliska Istitutet ad Stockholm Couty Coucil (OF ) for fiacial support. The authors declare o potetial coflicts of iterest with respect to the authorship ad/or publicatio of this article. Refereces Aebi M, Kuh C, Metzke CW, Strigaris A, Goodma R, Steihause HC The use of the Developmet ad Well-Beig Assessmet (DAWBA) i cliical practice: a radomized trial. Eur Child Adolesc Psychiatry. 21(10): Atoy MM, Barlow DH Specific phobias. I: Barlow DH, editor. 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10 Vol. 1 Issue 3 Cogitive Behavioral Therapy for Childre with Detal Axiety Roberts JF, Curzo ME, Koch G, Martes LC Review: behavior maagemet techiques i paediatric detistry. Eur Arch Paediatr Det. 11(4): Shahavaz S, Rutley S, Larsso K, Dahllöf G Childre ad parets experieces of cogitive behavioral therapy for detal axiety a qualitative study. It J Paediatr Det. 25(5): Svesso L, Larsso A, Ost L, Larsso Å, Öst L How childre experiece brief-exposure treatmet of specific phobias. J Cli Child Adolesc Psychol. 31(1): Wide Boma U, Broberg AG, Krekmaova L, Staberg M, Svesso C, Robertso A A explorative aalysis of the recruitmet of patiets to a radomised cotrolled trial i adolescets with detal axiety. Swed Det J. 38(1): Wide Boma U, Carlsso V, Westi M, Hakeberg M Psychological treatmet of detal axiety amog adults: a systematic review. Eur J Oral Sci. 121(3, Pt 2):