[Table], Frankel et al., 2010 - Therapies for Children With Autism Spectrum Disorders

Study Description	Intervention	Inclusion/Exclusion Criteria/Population	Baseline Measures	Outcomes
Author: Frankel et al., 2010 Country: US Practice setting: Academic Intervention setting: School and home Enrollment period: September 2003 to March 2008 Funding: NIH Author industry relationship disclosures: NR Design: Case series	Intervention: Children’s Friendship Training: children were integrated into classes being conducted by the UCLA Children’s Friendship Program, with no more than 4 children with ASD admitted to any class (class size was usually 10). Each training class was composed of children separated by no more than one grade level. Study children were not identified in any way to other class participants. Treatment consisted of 12 weekly sessions, each 60 minutes in length. Children and their parents were seen concurrently in separate locations (except for the finalization of the child’s homework assignment). Each child session (except the first and last) was composed of four segments: Children reported the results of their homework assignment (10 minutes) Didactic presentation and brief, coached behavioral rehearsal between two children (20 minutes) Coached play in which children practiced newly learned skills (25 minutes) Parents and children were reunited and finalized homework contracts. Number of sessions attended, mean ± SD: G1: 11.3 ± 0.8 G2: 10.7 ± 1.9	Inclusion criteria: Satisfied ADOS-G and ADI-R criteria for ASD Currently attending a 2^nd through 5^th grade regular classroom for most of the school day without a “shadow” or other closely supervising adult Not currently prescribed any psychotropic medication Verbal IQ > 60 Able to switch topics in conversation when the other person was interested in talking about something else Had adequate knowledge of rules in playing at least two common age- appropriate board games Knowledge of rules to play common school yard games Absence of a thought disorder Free of clinical seizure disorder, gross neurologic disease, or other medical disorders Exclusion criteria: See inclusion criteria Age, months ± SD: G1: 103.2 ± 15.2 G2: 101.5 ± 15.0 Mental age: WISC-III Verbal IQ, mean ± SD: G1: 106.9 ± 19.1 G2: 100.5 ± 15.7 Gender, n (%): Male: G1: 30 (85.7) G2: 28 (84.8)	Social skills: Loneliness scale score, mean ± SD: G1: 34.3 ± 12.3 G2: 37.8 ± 14.3 (n=32) Loneliness scale score, follow-up group, mean ± SD: G1: 36.3 ± 12.2 PHS popularity score, mean ± SD: G1: 7.2 ± 3.0 G2: 6.8 ± 3.00 PHS popularity score, follow-up group, mean ± SD: G1: 6.9 ± 3.0 Quality of Play Questionnaire score, mean ± SD: Host: G1: 2.4 ± 2.2 G2: 1.8 ± 2.3 (n=29) Guest: G1: 1.3 ± 1.6 G2: 1.1 ± 2.0 (n=29) Conflict: G1: 4.8 ± 4.2 G2: 5.1 ± 5.2 (n=27) Engage: G1: 4.2 ± 2.2 G2: 4.3 ± 2.1 (n=27) Disengage: G1: 5.2 ± 2.5 G2: 5.2 ± 2.2 (n=27) Quality of Play Questionnaire score, follow-up group, mean ± SD: Host: G1: 2.0 ± 2.1 Guest: G1: 1.4 ± 1.7 Conflict: G1: 4.3 ± 3.3	Social Skills: Loneliness scale score, mean ± SD: G1: 31.4 ± 8.5 G2: 38.9 ± 13.3 (n=32) G1/G2: P < 0.025 Loneliness scale score, follow-up group, mean ± SD: Post-treatment: G1: 31.6 ± 8.1 12 weeks: G1: 33.0 ± 13.7 G1/BL: P = NS G1/PT: P = NS PHS popularity score, mean ± SD: G1: 8.0 ± 2.8 G2: 6.4 ± 2.9 G1/G2: P < 0.025 PHS popularity score, follow-up group, mean ± SD: Post-treatment: G1: 7.9 ± 2.7 12 weeks: G1: 7.4 ± 2.8 G1/BL: P = NS G1/PT: P = NS Quality of Play Questionnaire score, mean ± SD: Host: G1: 3.7 ± 1.7 G2: 1.4 ± 2.0 (n=29) G1/G2: P < 0.0001
Homework required social contacts with children who were not class members Assessments: Children/parents in the intervention group completed outcome measures at baseline (just prior to receiving the intervention), the last night of the intervention, and at 12 week follow-up; waitlist controls completed outcome measures at baseline, 12 weeks later just prior to starting the intervention, and the last night of the intervention. Children and parents completed assessment measures in the presence of the research team, while teachers were mailed assessment measures at each of the testing periods. Child outcome measures: Loneliness Scale, PHS; parent measures: Quality of Play Questionnaire, SSRS; teacher measures: PEI; at baseline, WISC-III; VABS survey form; Socioeconomic Status Groups: G1: children’s friendship training intervention G2: children’s friendship training after 12 weeks; delayed treatment control Provider: Psychologist L.C.S.W. Undergraduate psychology students Measure of treatment fidelity reported: Yes Co-interventions held stable during treatment: NR Concomitant therapies: NR	Female: G1: 5 (14.3) G2: 5 (15.2) Race/ethnicity, n (%): White: 45 (66.2) Asian: 10 (14.7) African American: 7 (10.3) Hispanic: 4 (5.9) Pacific Islander: 1 (1.4) Native American: 1 (1.4) SES: Hollingshead index, mean ± SD: G1: 44.6 ± 10.6 G2: 50.6 ± 11.8 (n=32) Household income: NR Diagnostic approach: In Study Diagnostic tool/method: ADOS-G and ADI-R; High Functioning ASSQ Diagnostic category, n: Autism: 68 PDD-NOS: 0 Aspergers: 0 Other characteristics, n (%): Completely mainstreamed: 61 (89.7) Special education classes (but included in a main- streamed recess and mainstream classroom for part of the school day): 6 (8.8) Mainstream classroom with special help for 1–2 hours a day: 1 (1.5) Grade, mean ± SD: G1: 3.2 ± 1.0 G2: 3.4 ± 1.2	Engage: G1: 3.8 ± 2.1 Disengage: G1: 5.2 ± 2.3 SSRS score, mean ± SD: Assertion: G1: 9.5 ± 2.8 G2: 9.4 ± 3.4 Self-control: G1: 10.2 ± 3.4 G2: 9.0 ± 3.9 Externalizing: G1: 4.5 ± 2.6 G2: 5.4 ± 2.3 Internalizing: G1: 7.0 ± 1.7 G2: 7.2 ± 3.2 SSRS score, follow- up group, mean ± SD: Assertion: G1: 9.7 ± 2.8 Self control: G1: 9.8 ± 3.5 Externalizing: G1: 4.5 ± 2.4 Internalizing: G1: 7.1 ± 1.6 PEI score, mean ± SD: Withdrawal: G1: 4.0 ± 2.1 (n=31) G2: 3.8 ± 2.1 (n=28) Aggression: G1: 1.3 ± 1.7 (n=31) G2: 1.4 ± 1.8 (n=28) PEI score, follow-up group, mean ± SD: Withdrawal: G1: 4.2 ± 2.2 Aggression: G1: 1.5 ± 1.8 High functioning ASSQ, mean ± SD: G1: 22.4 ± 7.3 G2: 22.0 ± 9.3	Guest: G1: 2.0 ± 2.5 G2: 1.2 ± 1.5 (n=29) G1/G2: P = NS Conflict: G1: 1.9 ± 2.8 G2: 3.3 ± 3.2 (n=29) G1/G2: P = 0.069 Engage: G1: 4.7 ± 2.2 G2: 4.3 ± 1.7 (n=29) G1/G2: P = NS Disengage: G1: 2.3 ± 1.7 G2: 4.8 ± 2.1 (n=29) G1/G2: P < 0.0001 Quality of Play Questionnaire score, follow-up group, mean ± SD: Post-treatment: Host: G1: 4.0 ± 1.6 Guest: G1: 1.8 ± 2.6 Conflict: G1: 1.8 ± 3.0 Engage: G1: 4.5 ± 2.2 Disengage: G1: 2.1 ± 1.6 12 weeks: Host: G1: 3.1 ± 2.9 G1/BL: P = NS G1/PT: P < 0.05 Guest: G1: 1.9 ± 1.5 G1/BL: P = NS G1/PT: P = NS Conflict: G1: 2.0 ± 2.6 G1/BL: P = NS G1/PT: P < 0.0005
N at enrollment:^* G1: 35 G2: 33 N at follow-up: G1: 26 G2: 31		VABS score, mean ± SD: Communication: G1: 84.3 ± 20.5 (n=34) G2: 79.8 ± 15.3 Daily living: G1: 67.0 ± 18.2 (n=34) G2: 62.4 ± 15.7 Socialization: G1: 66.3 ± 10.8 (n=34) G2: 66.1 ± 10.8 Composite: G1: 68.1 ± 16.4 (n=34) G2: 64.4 ± 11.0	Engage: G1: 4.2 ± 2.0 G1/BL: P = NS G1/PT: P = NS Disengage: G1: 4.1 ± 2.2 G1/BL: P < 0.0001 G1/PT: P < 0.025SSRS score, mean ± SD: Assertion: G1: 11.8 ± 3.2 G2: 10.5 ± 3.2 G1/G2: P = 0.054 Self-control : G1: 12.2 ± 2.9 G2: 10.1 ± 3.7 G1/G2: P < 0.05 Externalizing: G1: 3.8 ± 2.1 G2: 5.2 ± 2.3 G1/G2: P = 0.062 Internalizing: G1: 6.4 ± 2.1 G2: 7.3 ± 2.5 G1/G2: P = 0.058 SSRS score, follow-up group, mean ± SD: Post-treatment: Assertion: G1: 11.7 ± 2.8 Self Control: G1: 12.0 ± 2.8 Externalizing: G1: 3.8 ± 2.0 Internalizing: G1: 6.2 ± 1.7 12 weeks: Assertion: G1: 12.0 ± 3.5 G1/BL: P = NS G1/PT: P < 0.0001 Self Control: G1: 11.8 ± 3.8 G1/BL: P = NS G1/PT: P < 0.005
			Externalizing: G1: 3.8 ± 2.5 G1/BL: P = NS G1/PT: P = NS Internalizing: G1: 6.0 ± 2.5 G1/BL: P = NS G1/PT: P < 0.025PEI score, mean ± SD: Withdrawal: G1: 3.6 ± 2.4 (n=31) G2: 3.7 ± 2.1 (n=28) G1/G2: P = NS Aggression: G1: 1.0 ± 1.3 (n=31) G2: 1.4 ± 2.0 (n=28) G1/G2: P = NS PEI score, follow- up group, mean ± SD: Post-treatment: Withdrawal: G1: 3.5 ± 2.5 Aggression: G1: 1.3 ± 1.3 12 weeks: Withdrawal: G1: 3.6 ± 2.8 G1/BL: P = NS G1/PT: P = NS Aggression: G1: 1.6 ± 1.7 G1/BL: P = NS G1/PT: P = NS Harms: NR Modifiers: NR

Study Description

Intervention

Inclusion/Exclusion
Criteria/Population

Baseline Measures

Outcomes

Author:
Frankel et al., 2010
Country:
US
Practice setting:
Academic
Intervention setting:
School and home
Enrollment period:
September 2003 to March 2008
Funding:
NIH
Author industry relationship disclosures:
NR
Design:
Case series

Intervention:
Children’s Friendship Training: children were integrated into classes being conducted by the UCLA Children’s Friendship Program, with no more than 4 children with ASD admitted to any class (class size was usually 10). Each training class was composed of children separated by no more than one grade level. Study children were not identified in any way to other class participants. Treatment consisted of 12 weekly sessions, each 60 minutes in length.
Children and their parents were seen concurrently in separate locations (except for the finalization of the child’s homework assignment). Each child session (except the first and last) was composed of four segments:

Children reported the results of their homework assignment (10 minutes)
Didactic presentation and brief, coached behavioral rehearsal between two children (20 minutes)
Coached play in which children practiced newly learned skills (25 minutes)
Parents and children were reunited and finalized homework contracts.

Number of sessions attended, mean ± SD:
G1: 11.3 ± 0.8
G2: 10.7 ± 1.9

Inclusion criteria:

Satisfied ADOS-G and ADI-R criteria for ASD
Currently attending a 2^nd through 5^th grade regular classroom for most of the school day without a “shadow” or other closely supervising adult
Not currently prescribed any psychotropic medication
Verbal IQ > 60
Able to switch topics in conversation when the other person was interested in talking about something else
Had adequate knowledge of rules in playing at least two common age- appropriate board games
Knowledge of rules to play common school yard games
Absence of a thought disorder
Free of clinical seizure disorder, gross neurologic disease, or other medical disorders

Exclusion criteria:

See inclusion criteria

Age, months ± SD:
G1: 103.2 ± 15.2
G2: 101.5 ± 15.0
Mental age:
WISC-III Verbal IQ, mean ± SD:
G1: 106.9 ± 19.1
G2: 100.5 ± 15.7
Gender, n (%):
Male:
G1: 30 (85.7)
G2: 28 (84.8)

Social skills:
Loneliness scale score, mean ± SD:
G1: 34.3 ± 12.3
G2: 37.8 ± 14.3 (n=32)
Loneliness scale score, follow-up group, mean ± SD:
G1: 36.3 ± 12.2
PHS popularity score, mean ± SD:
G1: 7.2 ± 3.0
G2: 6.8 ± 3.00
PHS popularity score, follow-up group, mean ± SD:
G1: 6.9 ± 3.0
Quality of Play Questionnaire score, mean ± SD:
Host:
G1: 2.4 ± 2.2
G2: 1.8 ± 2.3 (n=29)
Guest:
G1: 1.3 ± 1.6
G2: 1.1 ± 2.0 (n=29)
Conflict:
G1: 4.8 ± 4.2
G2: 5.1 ± 5.2 (n=27)
Engage:
G1: 4.2 ± 2.2
G2: 4.3 ± 2.1 (n=27)
Disengage:
G1: 5.2 ± 2.5
G2: 5.2 ± 2.2 (n=27)
Quality of Play Questionnaire score, follow-up group, mean ± SD:
Host:
G1: 2.0 ± 2.1
Guest:
G1: 1.4 ± 1.7
Conflict:
G1: 4.3 ± 3.3

Social Skills:
Loneliness scale score, mean ± SD:
G1: 31.4 ± 8.5
G2: 38.9 ± 13.3 (n=32)
G1/G2: P < 0.025
Loneliness scale score, follow-up group, mean ± SD:
Post-treatment:
G1: 31.6 ± 8.1
12 weeks:
G1: 33.0 ± 13.7
G1/BL: P = NS
G1/PT: P = NS
PHS popularity score, mean ± SD:
G1: 8.0 ± 2.8
G2: 6.4 ± 2.9
G1/G2: P < 0.025
PHS popularity score, follow-up group, mean ± SD:
Post-treatment:
G1: 7.9 ± 2.7
12 weeks:
G1: 7.4 ± 2.8
G1/BL: P = NS
G1/PT: P = NS
Quality of Play Questionnaire score, mean ± SD:
Host:
G1: 3.7 ± 1.7
G2: 1.4 ± 2.0 (n=29)
G1/G2: P < 0.0001

Homework required social contacts with children who were not class members
Assessments: Children/parents in the intervention group completed outcome measures at baseline (just prior to receiving the intervention), the last night of the intervention, and at 12 week follow-up; waitlist controls completed outcome measures at baseline, 12 weeks later just prior to starting the intervention, and the last night of the intervention. Children and parents completed assessment measures in the presence of the research team, while teachers were mailed assessment measures at each of the testing periods.
Child outcome measures: Loneliness Scale, PHS; parent measures: Quality of Play Questionnaire, SSRS; teacher measures: PEI; at baseline, WISC-III; VABS survey form; Socioeconomic Status
Groups:
G1: children’s friendship training intervention
G2: children’s friendship training after 12 weeks; delayed treatment control
Provider:

Psychologist
L.C.S.W.
Undergraduate psychology students

Measure of treatment fidelity reported:
Yes
Co-interventions held stable during treatment:
NR
Concomitant therapies:
NR

Female:
G1: 5 (14.3)
G2: 5 (15.2)
Race/ethnicity, n (%):
White: 45 (66.2)
Asian: 10 (14.7)
African American: 7 (10.3)
Hispanic: 4 (5.9)
Pacific Islander: 1 (1.4)
Native American: 1 (1.4)
SES:
Hollingshead index, mean ± SD:
G1: 44.6 ± 10.6
G2: 50.6 ± 11.8 (n=32)
Household income: NR
Diagnostic approach:
In Study
Diagnostic tool/method:
ADOS-G and ADI-R; High Functioning ASSQ
Diagnostic category, n:
Autism: 68
PDD-NOS: 0
Aspergers: 0
Other characteristics, n (%):
Completely mainstreamed: 61 (89.7)
Special education classes (but included in a main- streamed recess and mainstream classroom for part of the school day): 6 (8.8)
Mainstream classroom with special help for 1–2 hours a day: 1 (1.5)
Grade, mean ± SD:
G1: 3.2 ± 1.0
G2: 3.4 ± 1.2

Engage:
G1: 3.8 ± 2.1
Disengage:
G1: 5.2 ± 2.3
SSRS score, mean ± SD:
Assertion:
G1: 9.5 ± 2.8
G2: 9.4 ± 3.4
Self-control:
G1: 10.2 ± 3.4
G2: 9.0 ± 3.9
Externalizing:
G1: 4.5 ± 2.6
G2: 5.4 ± 2.3
Internalizing:
G1: 7.0 ± 1.7
G2: 7.2 ± 3.2
SSRS score, follow- up group, mean ± SD:
Assertion:
G1: 9.7 ± 2.8
Self control:
G1: 9.8 ± 3.5
Externalizing:
G1: 4.5 ± 2.4
Internalizing:
G1: 7.1 ± 1.6
PEI score, mean ± SD:
Withdrawal:
G1: 4.0 ± 2.1 (n=31)
G2: 3.8 ± 2.1 (n=28)
Aggression:
G1: 1.3 ± 1.7 (n=31)
G2: 1.4 ± 1.8 (n=28)
PEI score, follow-up group, mean ± SD:
Withdrawal:
G1: 4.2 ± 2.2
Aggression:
G1: 1.5 ± 1.8
High functioning ASSQ, mean ± SD:
G1: 22.4 ± 7.3
G2: 22.0 ± 9.3

Guest:
G1: 2.0 ± 2.5
G2: 1.2 ± 1.5 (n=29)
G1/G2: P = NS
Conflict:
G1: 1.9 ± 2.8
G2: 3.3 ± 3.2 (n=29)
G1/G2: P = 0.069
Engage:
G1: 4.7 ± 2.2
G2: 4.3 ± 1.7 (n=29)
G1/G2: P = NS
Disengage:
G1: 2.3 ± 1.7
G2: 4.8 ± 2.1 (n=29)
G1/G2: P < 0.0001
Quality of Play Questionnaire score, follow-up group, mean ± SD:
Post-treatment:
Host:
G1: 4.0 ± 1.6
Guest:
G1: 1.8 ± 2.6
Conflict:
G1: 1.8 ± 3.0
Engage:
G1: 4.5 ± 2.2
Disengage:
G1: 2.1 ± 1.6
12 weeks:
Host:
G1: 3.1 ± 2.9
G1/BL: P = NS
G1/PT: P < 0.05
Guest:
G1: 1.9 ± 1.5
G1/BL: P = NS
G1/PT: P = NS
Conflict:
G1: 2.0 ± 2.6
G1/BL: P = NS
G1/PT: P < 0.0005

N at enrollment:^*
G1: 35
G2: 33
N at follow-up:
G1: 26
G2: 31

VABS score, mean ± SD:
Communication:
G1: 84.3 ± 20.5 (n=34)
G2: 79.8 ± 15.3
Daily living:
G1: 67.0 ± 18.2 (n=34)
G2: 62.4 ± 15.7
Socialization:
G1: 66.3 ± 10.8 (n=34)
G2: 66.1 ± 10.8
Composite:
G1: 68.1 ± 16.4 (n=34)
G2: 64.4 ± 11.0

Engage:
G1: 4.2 ± 2.0
G1/BL: P = NS
G1/PT: P = NS

Disengage:
G1: 4.1 ± 2.2
G1/BL: P < 0.0001
G1/PT: P < 0.025SSRS score, mean ± SD:
Assertion:
G1: 11.8 ± 3.2
G2: 10.5 ± 3.2
G1/G2: P = 0.054
Self-control :
G1: 12.2 ± 2.9
G2: 10.1 ± 3.7
G1/G2: P < 0.05
Externalizing:
G1: 3.8 ± 2.1
G2: 5.2 ± 2.3
G1/G2: P = 0.062
Internalizing:
G1: 6.4 ± 2.1
G2: 7.3 ± 2.5
G1/G2: P = 0.058
SSRS score, follow-up group, mean ± SD:
Post-treatment:
Assertion:
G1: 11.7 ± 2.8
Self Control:
G1: 12.0 ± 2.8
Externalizing:
G1: 3.8 ± 2.0
Internalizing:
G1: 6.2 ± 1.7
12 weeks:
Assertion:
G1: 12.0 ± 3.5
G1/BL: P = NS
G1/PT: P < 0.0001
Self Control:
G1: 11.8 ± 3.8
G1/BL: P = NS
G1/PT: P < 0.005

Externalizing:
G1: 3.8 ± 2.5
G1/BL: P = NS
G1/PT: P = NS
Internalizing:
G1: 6.0 ± 2.5
G1/BL: P = NS
G1/PT: P < 0.025PEI score, mean ± SD:
Withdrawal:
G1: 3.6 ± 2.4 (n=31)
G2: 3.7 ± 2.1 (n=28)
G1/G2: P = NS
Aggression:
G1: 1.0 ± 1.3 (n=31)
G2: 1.4 ± 2.0 (n=28)
G1/G2: P = NS
PEI score, follow- up group, mean ± SD:
Post-treatment:
Withdrawal:
G1: 3.5 ± 2.5
Aggression:
G1: 1.3 ± 1.3
12 weeks:
Withdrawal:
G1: 3.6 ± 2.8
G1/BL: P = NS
G1/PT: P = NS
Aggression:
G1: 1.6 ± 1.7
G1/BL: P = NS
G1/PT: P = NS
Harms:
NR
Modifiers:
NR

From: Appendix C, Evidence Tables

Therapies for Children With Autism Spectrum Disorders.

Comparative Effectiveness Reviews, No. 26.

Warren Z, Veenstra-VanderWeele J, Stone W, et al.

Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Apr.

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