Participant Demographic Characteristics
Sociodemographic characteristics of the sample of 50 caregivers and 50 individuals with ASD are presented in Table 1.The mean age of individuals with ASD as reported by their caregivers was 12.4 years (range 2–40 years). Among individuals with ASD, there were more males (n=33, 66%) than females ASD (n=17, 34%). Caregivers had a mean age of 42.3 years (range 26–49 years). Most caregivers were female (n =44, 88%), non-Hispanic (n=46, 92%), White (n =30, 60%), and married (n=26, 52%). Regarding caregiver level of education, more than half of the caregivers reported some college, but no degree (n=26, 52%), and nearly half of the caregiver sample reported being employed full-time (n=24, 48%).
Table 1
Sociodemographic characteristics of caregivers of individuals with ASD
Characteristic
|
Total (N=50)
|
Age of individual with ASD (years)
|
|
Mean (SD)
|
12.4 (8.15)
|
Median [Range]
|
12 [2–40]
|
Gender of individual with ASD, n (%)
|
|
Female
|
17 (34)
|
Male
|
33 (66)
|
Age of caregiver (years)
|
|
Mean (SD)
|
42.3 (8.88)
|
Median [Range]
|
43 [26–59]
|
Gender of caregiver, n (%)
|
|
Male
|
6 (12)
|
Female
|
44 (88)
|
Ethnicity of caregiver, n (%)
|
|
Not Hispanic or Latino
|
46 (92)
|
Racial background of caregiver, n (%)
|
|
White
|
30 (60)
|
Black or African American
|
14(28)
|
Other
|
6 (12)
|
Education status of caregiver, n (%)
|
|
Secondary school
|
1 (2)
|
Some college
|
26 (52)
|
College degree
|
15 (30)
|
Postgraduate degree
|
7 (14)
|
Doctorate degree
|
1 (2)
|
Employment status of caregiver, n (%)
|
|
Part-time Work
|
8 (16)
|
Full-time Work
|
24 (48)
|
Homemaker
|
16 (32)
|
Retired
|
1 (2)
|
Disabled
|
1 (2)
|
Clinical characteristics of the individuals with ASD,as reported by caregivers,are found in Table 2.Most individuals with ASD were diagnosed by a psychologist/neuropsychologist/psychiatrist (n=23, 46%),or a pediatrician/primary care provider (n=15, 30%), and the majority received their diagnosis between the ages of two and three years (n=28, 56%). About half had fluent language (“speaks in full sentences,”n=21, 42%), and the majority had at least one comorbid diagnosis (n=32, 64%). Most individuals with ASD (n=47, 94%) had had no significant changes in their condition in the past month, while three (6%) were reported to have had significant changes (two symptoms improved, one not known). For individuals with ASD still in school, the most commonly reported educational placements included regular classroom (n=13, 26%) and a self-contained classroom (n=9, 18%). Other than the higher proportion of females with ASD in our sample, these demographic and clinical characteristics are broadly similar to those of participants commonly reported and seen in clinical trials[21]
Table 2
Clinical characteristics of individuals with ASD
Characteristic
|
Total (N = 50)
|
Age at Diagnosis, n (%)
|
|
≤ 3 years
|
31 (62)
|
≤ 9 years
|
16 (32)
|
≤ 14 years
|
3 (6)
|
Level of language, n (%)
|
|
No language
|
4 (8)
|
Puts signs or picture exchange together to make simple sentences
|
7 (14)
|
Single words / 2- to 3-word utterances
|
10 (20)
|
Uses simple sentences
|
8 (16)
|
Speaks in full sentences
|
21 (42)
|
Other conditions, n (%)
|
|
ADD/ADHD
|
12 (24)
|
Anxiety
|
3 (6)
|
Epilepsy/seizures
|
2 (4)
|
Global development delay
|
2 (4)
|
Intellectual disability/learning disability (e.g. math, reading)
|
8 (16)
|
Sickle cell
|
1 (2)
|
Speech disorder
|
1 (2)
|
None
|
18 (36)
|
Other: (e.g. behavior issues, insomnia)
|
3 (6)
|
ABI content validation
Overall Content Validity
Analysis of the transcripts across itemswas carried out to determine consistency of responses between caregivers, and confirmation that the item conveyed the intended meaning. Qualitative analysis involved identifying the experiences, description and perceptions that went into the respondents’ answers.
This analysis was used alongside qualitative analysis of whether respondents indicated an item was understood to determine whether wording changes, example additions, or item removal was appropriate.
The box below shows examples of the “think-aloud” responses for a specific item “Has difficulty being flexible” with the example “Has a hard time changing his/her mind. Responses demonstrate differences in approach with some participants (example 1&2) requiring minimum prompts to “think-aloud” and others (example 3&4) where the prompts were used to elicit responses(interview questions are in bold font).
Has Difficulty Being Flexible
Example 1& 2: Participant spontaneously thinks out loud
001-003: Has difficulty being flexible—example, has a hard time changing his/her mind—yes, that is “very often”.
That’s also ( a response option of) “very often,” okay.
001-003: Yeah, she is very in a routine. If anything is out of place, the smallest thing will cause a meltdown. Like she knows right now school is Monday through Friday, she knows that she gets up at the same time every day. Um, in terms of eating right now, that’s always been a little bit flexible, but other than that everything stays the same. So, like when—say, for instance, she didn’t understand summer vacation, when the kids are out of school. She was upset that she couldn’t go to school, because that’s become a routine to her.
022-007: Has difficulty being flexible—has a hard time changing his or her mind. Uh, yeah, that would be “often”. That one’s really straightforward, too, you don’t need to change that at all. These kids are, you know, they just—things change and they have trouble moving with it—that’s the best way I could say it
Example 3 & 4 Participant requires more prompts to think out loud
001-005: Has difficulty being flexible. Example, has a hard time changing his or her mind.
What would you select for your answer, and why?
001-005: Um, I would answer “never”.
Never. And why is that?
001-005: Um, my son is not really hard to deal with, like when we need to go out, uh, like we need to go out, it’s like right now, then even if he’s still watching TV, most of the time or most of the day he just watch TV, and when I tell him we need to go out, we need to go somewhere, even though he act like he don’t understand, but when I try, start changing his clothes, put his shoes on, he don’t really seem to get upset. He just, um, he just let me take him to wherever.
002-010: Yes, I’m there. Has difficulty being flexible. Um, not really. Maybe once in awhile. I would say “sometimes” again.
Why would you say that? What’s your reason for that?
002-010: Because he, he knows the kind of society that we live in. He knows our day to day lives are constantly changing. What I find myself doing is saying to him, this weekend, I don’t know, we’re singing at the, we sing in church. We’re singing at the 8:00, we’re singing at the 9:30, we’re singing at the 11:00, we’re, you know, I will basically have to tell him what’s going on, or I will tell him when his father is working and where he will be, or if we’re able to go on vacation and where that might be. Um, and I feel as though the more I prepare him and communicate with him, the flexibility is better. So I will have to say to him, I know your violin lesson is on Friday at 4:30, but your teacher, [name removed], needs you to come today at 3:30, and he’ll say but it’s on Wednesday, and I’ll say yes, it’s Wednesday and we need to do it today, so let’s get ourselves together and get over there kind of a thing.
|
ABI Instructions
Participants were asked to comment on their impressions of the overall ABI instructions. Almost all participants that were asked to provide comments (n=36/37, 97%) stated the instructions were “easy” and provided a good generalized overview of the questionnaire.
Are the instructions clear and easy to understand?
Some participants indicated more clarification was needed to clarify the two rating categories in the instructions. Six participants indicated that the term “dimension” could be changed to enhance understanding.
As a result, the term “dimension” was removed from the instructions, and the description of the “quality” response was reworded.
Recall period
Participants also provided feedback on the recall period of over the past 7 days. All participants who were asked to describe their understanding of the recall period (n=42) were able to successfully explain it as intended, although there was some slight potential for confusion.
In order to clarify the recall timeframe, after the first round of the ABI interviews, the wording was modified from “over the past week” to “over the past 7 days”.
Response options
Participants were asked a series of follow-up questions to assess general understanding and conceptualization of the response options. For example, most participants (n=38/41; 93%) stated the response options for both domains were easy and clear and most stated they did not have any suggested changes. For those who had difficulty with the response scale (n=3/41; 7%), they indicated the option “with support” lacked clarity, the overall options were less clear than the frequency responses andhad difficulty in differentiating “with support” vs. “with some reminders.”
Overall response
There is no universal standard for participant comprehension, but with a clear, well-designed and simple instrument, a guideline of approximately 90% of respondents should be expected to understand the instructions, items, and response options[15].In round 1 of interviews, 2 items in the SC domain and 1 item in the RB domain were understood <90% of the time. All items in the remaining domains were understood >90% of the time (Table 3).
Table 3
Percentage of caregivers’ understanding in core domains of SC and RB
Domain
|
Understanding
|
Social Communication
|
Round 1 n (%)
|
Round 2 n (%)
|
1.
|
Responds to familiar things, e.g., when a particular song is sung, when a familiar name is mentioned
|
30/33 (85%)
|
Removeda
|
2.
|
Shows appropriate affection towards familiar people
|
32/33 (97%)
|
12 (100%)
|
3.
|
Shows an interest in what other people are doing
|
31/32 (97%)
|
11/12 (92%)
|
4.
|
Responds to attempts to initiate social interaction
|
28/31 (90%)
|
12/12 (100%)
|
5.
|
Gives things to others in order to get help, e.g., brings you a box he/she can’t open
|
28/30 (93%)
|
12/12 (100%)
|
6.
|
Is flexible when playing with others or taking part in social activities
|
30/31 (97%)
|
10/10 (100%)
|
7.
|
Is creative or imaginative in play or other activities, e.g., make believe play or has new or original ideas
|
31/31 (100%)
|
11/11 (100%)
|
8.
|
Is able to take turns in conversation, e.g., responds to and builds on what has been said, using speech or signs or gestures
|
29/31 (94%)
|
11/11 (100%)
|
9.
|
Directs facial expression towards other people to communicate feelings, e.g., gives eye contact, shows emotion on face
|
31/31 (100%)
|
10/10 (100%)
|
10.
|
Offers information about his/her own thoughts or feelings, e.g., able to talk or sign about what he/she is thinking and feeling
|
26/26 (100%)
|
11/11 (100%)
|
11.
|
Waves ‘hello’ and ‘goodbye’
|
27/27 (100%)
|
11/11 (100%)
|
12.
|
Uses common gestures, e.g., nods, shakes head
|
27/28 (96%)
|
11/11 (100%)
|
13.
|
Combines gestures with vocalizations to enhance communication, e.g., uses actions and words to get point across
|
25/25 (100%)
|
11/11 (100%)
|
14.
|
Use tone of voice appropriately, e.g., tone changes according to what he/she is saying
|
25/26 (96%)
|
11/11 (100%)
|
14.
|
Use tone of voice appropriately, e.g., tone changes according to what he/she is saying
|
25/26 (96%)
|
11/11 (100%)
|
15.
|
Responds to other people’s emotions, e.g., notices or comments on how others are feeling
|
27/27 (100%)
|
10/11 (91%)
|
16.
|
Looks when he/she is called or praised
|
27/27 (100%)
|
9/11 (82%)
|
17.
|
Looks where another person is looking or pointing
|
27/27 (100%)
|
10/11 (91%)
|
18.
|
Shows pleasure in shared interactions, e.g., enjoys doing things with people
|
26/27 (96%)
|
11/11 (100%)
|
19.
|
Uses facial expressions that are appropriate to the situation, e.g., looks sad when someone is hurt, smiles when happy
|
26/26 (100%)
|
10/11 (91%)
|
20.
|
Resists affection from familiar people
|
25/26 (96%)
|
11/11 (100%)
|
21.
|
Shows inappropriate affection towards unfamiliar people, e.g., hugging people that he or she does not know
|
24/25 (96%)
|
11/12 (92%)
|
22.
|
Has difficulty interacting with peers, e.g., finds it hard to make and keep friends
|
24/25 (96%)
|
11/12 (92%)
|
23.
|
Says socially inappropriate things OR makes inappropriate social approaches, e.g., will tell people they have a large nose, touches or strokes clothes or body parts
|
26/27 (96%)
|
10/11 (91%)
|
24.
|
Attends to parts of sentences and misinterprets whole, e.g., focus on one or two words and misses the point
|
14/22 (64%)
|
7/11 (64%)a
|
Restrictive Behaviors
|
Round 1
|
Round 2
|
25.
|
Gets upset over small changes in routine
|
26/26 (100%)
|
12/12 (100%)
|
26.
|
Has difficulty being flexible, e.g., has a hard time changing his/her mind
|
24/24 (100%)
|
12/12 (100%)
|
27.
|
Resists trying out new things, e.g., won’t go to new places, avoids new foods
|
24/24 (100%)
|
12/12 (100%)
|
28.
|
Insists on doing things the same way each time
|
23/23 (100%)
|
11/12 (92%)
|
29.
|
Is fixated on certain topics or activities and unable to move on
|
24/24 (100%)
|
12/12 (100%)
|
30.
|
Has an unusually narrow range of interests
|
21/24 (88%)
|
11/12 (92%)a
|
31.
|
Repeats /echoes what others say, e.g., immediately repeats words or phrases
|
23/23 (100%)
|
12/12 (100%)
|
Items with <90% understanding were reworded or removed for round 2. In addition, if follow up comments from caregivers indicated confusion in response or similarity and overlap of items, these items were considered for removal or rewording.
Use of examples
The ABI contains some items with examples, which were included based on quantitative and qualitative feedback in previous rounds of instrument development. Caregivers provided feedback regarding the examples either spontaneously, or in response to a prompt. The overall response to the inclusion and utility of examples was positive.It was also confirmed that some items were appropriate and easily understood without examples. Some caregivers suggested other items for which an example might be helpful. These suggestions were discussed by the scale development team and, where appropriate, examples were added to items for round 2.
Item changes
Items changed as a result of the participant comments are shown in a tracking matrix (Table4). Changes included rewording of items, where participants indicated wording was confusing (e.g. attends to parts of sentences, shown below) or where follow up comments from participantsindicated some differences in understanding from expected meaning. Other changes included the addition of an example or removal of an item. Changes were then presented and confirmed in round 2.
Table 4
Modifications made to the ABI following round 1 of cognitive interviews
Wording Presented in Round 1 Final Wording Presented in Round 2 Rationale
|
Social Communication
|
Shows an interest in what other people are doing
|
Pays attention to or notices what other people are doing
|
Re-worded to clarify that this is more about general awareness of people and less dependent on what people are actually doinga
|
Responds to attempts to initiate social interaction
|
Responds positively when others try to start social interactions
|
Re-worded to provide claritya
|
Combines gestures with vocalizations to enhance communication, e.g., uses actions and words to get point across
|
Combines body language with words or sounds to support communication, e.g., uses actions and words to get point across
|
Re-worded to simplify so it was easier to understanda
|
Attends to parts of sentences and misinterprets whole, e.g., focuses on one or two words and misses the point
|
Attends to parts of sentences and misinterprets whole sentences, e.g., focuses on one or two words and misses the point
|
The term “sentences” was added after “whole” to capture the intended meaning of the itema
|
Resists affection from familiar people
|
Resists affection from familiar people e.g. pulls away from family members/close friends or rejects verbal displays of affection
|
Examples were added to capture the intended meaning of the itema
|
Responds to familiar things, e.g., when a particular song is sung, when a familiar name is mentioned
|
Removed
|
Removed at it was considered unsuitable for older individuals and some caregivers had difficulty interpretingb
|
Restrictive Behavior
|
Has mannerisms or odd ways of moving her/his hands or fingers, e.g., flapping or moving fingers in front of eyes
|
Has mannerisms or odd ways of moving her/his hands or fingers, e.g., moving fingers in front of eyes
|
The term “flapping” was removed from the example, this change was based on alleviating potential confusion of this itema
|
Makes repetitive movements, e.g., flapping arms, rocking body, rolling head
|
Makes repetitive movements, e.g., flapping arms, rocking body, rolling head, spinning or tapping objects
|
The example “spinning or tapping objects” was added to the example to provide clarity to better understand the item. It was combined with below itema
|
Attempts to harm him/herself
|
Behaves in a way that can cause injury to self, e.g., biting self, picking skin, banging head
|
Reworded and examples were added. The rationale to reword was based on providing simpler language to better understand the item clarifying this is not a suicide assessment itema
|
Has sensitivities to certain food textures
|
Is overly sensitive to certain food textures, e.g., refuses food that is too crunchy, or too soft
|
Reworded and an example was added based on providing clarification related to food allergies and/or sensitivitiesa
|
Has an unusually narrow range of interests
|
Has a very limited range of interests
|
“Unusually narrow” was removed and replaced with “a very limited” to provide clarity to the item as there was difficulty understanding the terms “unusually narrow”a
|
Uses objects repetitively
|
Removed
|
Removing this item was based on being potentially confusing. This was combined and covered in the repetitive movements itemb
|
Mood and Anxiety
|
Is irritable and whiny, e.g., grouchy, moaning when unhappy
|
Is irritable, e.g., grouchy, cranky, moaning when unhappy
|
The term “whiny” was removed and an example was added due to the lack of understanding of the term “whiny”a
|
Worries about things, e.g., generally worries about minor things, making mistakes, going to school
|
Worries about minor things
|
The term “minor” was added and the example was removed for simplificationa
|
Clings to adults or is too dependent on them
|
Clings to adults or is overly dependent on them
|
The term “too” was removed and replaced with “overly” based on providing clarification to better understand this item for younger children’s ordinary behavior of dependencea
|
Complains about physical problems without a known medical reason, e.g., complains about aches and pains which may not be there
|
Removed
|
Removed due to the potential for this item to capture typical child behavior rather than mood or anxiety concerns. Additionally, this item was removed due to ambiguity if the child is non-verbalb
|
Looks worried or concerned, e.g., has a fearful worried expression
|
Removed
|
Removed based on reducing the number of items in this domain and low frequency of occurrence (from this study and previous data)c
|
Gets upset when separated from a caregiver
|
Removed
|
Removed based on similarity to clings to adults or is too dependent on themc
|
Challenging Behavior
|
Runs away
|
Runs or wanders away, e.g., does not stay in the place they should be
|
The phrase “or wanders” and examples were added to provide clarity to the item so that it is interpreted as “wandering or running away”a
|
Is mean to animals, e.g., pulls pet’s tail, shoves, kicks
|
Removed
|
Removed based on the potential to capture behaviors observed during childhood rather than challenging behaviors associated with ASD. It was also removed because of the low incidence of the behavior, thus the potential to change in response to interventionc
|
Hits or kicks
|
Removed
|
Removed based on the potential to capture behaviors typical during childhood rather than challenging behaviors associated with ASD. This item was also considered to overlap with physical aggressionc
|
Screams, yells, and cries
|
Removed
|
Removed based on the potential for this item to capture behaviors typical of children rather than challenging behaviors associated with ASD and similarity to other itemsc
|
Removal of items
In three cases, an item was removed because of participant difficulties with understanding. When considering removal, several factors were considered, including overlap with other items, comments from participants about suitability of an item for certain levels of verbal ability or age, number of responses at floor/ceiling, and perceived lower ability to detect change.
For example, “Uses objects repetitively”was removed because of the potential for differences in understanding by caregivers, and its similarity to other items in the domain. The item was combined with another item regarding repetitive and stereotypical behaviors in order to avoid confusion and reduce participant response burden (“Makes repetitive movements,e.g., flapping arms, rocking body, rolling head, spinning or tapping objects”).
“Response to familiar things” was removed due to reported ambiguity by some caregivers. In addition, the high level of endorsement of this item by caregivers in this study along with previous data, may leave little room for change in response to intervention.
The item “Complains about physical problems without a known medical reason” was reported by three caregivers of younger and older minimally verbal individuals as not relevant or applicable to their child and was therefore removed.
Overall impressions
When asked about overall impressions of the ABI, participants indicated the questions were applicable, straightforward, and presented in language that was respectful of caregivers for individuals with ASD. Examples of responses included the following: