Trial Outcomes & Findings for Comparative Efficacy of Self-directed & Therapist-assisted Telehealth Parent Training Intervention for Children With ASD (NCT NCT02721381)
NCT ID: NCT02721381
Last Updated: 2025-02-07
Results Overview
Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.
TERMINATED
NA
130 participants
Post-treatment (6 months)
2025-02-07
Participant Flow
Recruitment took place in Michigan and focused on underserved communities as defined by residence in a Rural Health and/or Health Provider Shortage Area by the U.S. Health Resource \& Services Administration; however, families did not have to live in an underserved community to be enrolled.
Participant milestones
| Measure |
Parent: Self-Directed Group
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Child: Self-Directed Group
Child participants will receive Project ImPACT intervention from their parent as trained in the self-directed group.
|
Parent: Therapist-Assisted Group
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Child: Therapist-Assisted Group
Child participants will receive Project ImPACT intervention from their parent as trained in the therapist-assisted group.
|
Parent: Information and Resource Support Control Group
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
Child: Information and Resource Support Group
Child participants will interact with their parent without training in Project ImPACT.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
22
|
22
|
19
|
19
|
|
Overall Study
COMPLETED
|
21
|
21
|
21
|
21
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
Baseline characteristics by cohort
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Child: Self-Directed Group
n=24 Participants
Child participants will receive Project ImPACT intervention from their parent as trained in the self-directed group.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, parent participant, and child participant and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Child: Therapist-Assisted Group
n=22 Participants
Child participants will receive Project ImPACT intervention from their parent as trained in the therapist-assisted group.
|
Parent: Information and Resource Support Control Group
n=19 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
Child: Information and Resource Support
n=19 Participants
Child participants will interact with their parent without training in Project ImPACT.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
19 Participants
n=19 Participants
|
65 Participants
n=130 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
22 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
19 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
65 Participants
n=130 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=130 Participants
|
|
Age, Continuous
|
35.75 years
STANDARD_DEVIATION 7.56 • n=24 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
3.80 years
STANDARD_DEVIATION 1.55 • n=24 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
35.32 years
STANDARD_DEVIATION 4.04 • n=22 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
3.99 years
STANDARD_DEVIATION 1.55 • n=22 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
34.56 years
STANDARD_DEVIATION 6.05 • n=18 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
4.01 years
STANDARD_DEVIATION 1.55 • n=18 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
19.60 years
STANDARD_DEVIATION 3.74 • n=128 Participants • One family withdrew from IRS control group after random assignment due to displeasure at group assignment and asked for data to be removed.
|
|
Sex: Female, Male
Female
|
20 Participants
n=24 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
9 Participants
n=24 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
17 Participants
n=22 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
5 Participants
n=22 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
17 Participants
n=18 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
1 Participants
n=18 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
69 Participants
n=128 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
|
Sex: Female, Male
Male
|
4 Participants
n=24 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
15 Participants
n=24 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
5 Participants
n=22 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
17 Participants
n=22 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
1 Participants
n=18 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
17 Participants
n=18 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
59 Participants
n=128 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
|
Race/Ethnicity, Customized
Minoritized Race or Ethnicity
|
7 Participants
n=24 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
7 Participants
n=24 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
5 Participants
n=22 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
10 Participants
n=22 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
4 Participants
n=18 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
5 Participants
n=18 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
38 Participants
n=128 Participants • One family withdrew from the study after group assignment to IRS Control condition due to dissatisfaction with group assignment and requested all data to be withdrawn.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
22 participants
n=22 Participants
|
22 participants
n=22 Participants
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
130 participants
n=130 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (6 months)Population: Analysis of parent data
Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Project ImPACT Intervention Fidelity Checklist
|
2.95 score on a scale
Standard Error .15
|
3.62 score on a scale
Standard Error .16
|
2.83 score on a scale
Standard Error .18
|
PRIMARY outcome
Timeframe: Follow up (9 months)Population: Analysis of parent data
Parents' use of the intervention strategies with their child is measured during a parent-child interaction in the home using the Project ImPACT Intervention Fidelity Checklist (Ingersoll \& Dvortcsak, 2019). Parents are asked to (1) play with their child for 10 minutes with a standard set of toys; and (2) have a small snack or meal with their child for 10 minutes. Parents are instructed to interact with their child as they typically would during both activities. Coders rated the parents' use of each of the five Project ImPACT intervention strategies on a scale of 1 ("does not implement the strategy, or almost all attempts to use the strategy are incorrect.") to 5 ("implements the strategy effectively throughout the session"). Scores for each strategy were averaged to form an overall fidelity rating for each activity. Fidelity ratings for each activity were averaged to form the parent fidelity variable.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Project ImPACT Intervention Fidelity Checklist
|
3.12 score on a scale
Standard Error .16
|
3.81 score on a scale
Standard Error .16
|
2.89 score on a scale
Standard Error .19
|
PRIMARY outcome
Timeframe: Post-Treatment (6 months)The PSOC measures the extent to which parents believe they have the skills and knowledge needed to be good parents (efficacy) and their perceptions regarding the value of parenthood (satisfaction). Parents rated 17 items from 1 ("Strongly disagree") to 6 ("Strongly agree"). Items are summed, with higher scores indicative of higher parenting self-efficacy. Scores can range from 17 to 102, with higher scores indicative of greater self-efficacy
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Parent Sense of Competence (PSOC)
|
74.06 score on a scale
Standard Error 2.41
|
74.45 score on a scale
Standard Error 2.44
|
70.76 score on a scale
Standard Error 2.91
|
PRIMARY outcome
Timeframe: Follow up (9 months)The PSOC measures the extent to which parents believe they have the skills and knowledge needed to be good parents (efficacy) and their perceptions regarding the value of parenthood (satisfaction). Parents rated 17 items from 1 ("Strongly disagree") to 6 ("Strongly agree"). Items are summed, scores can range from 17 to 102, with higher scores indicative of higher parenting self-efficacy.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Parent Sense of Competence (PSOC)
|
72.13 score on a scale
Standard Error 2.37
|
73.15 score on a scale
Standard Error 2.44
|
69.09 score on a scale
Standard Error 2.78
|
PRIMARY outcome
Timeframe: Post-treatment (6 months)Children's use of intentional communication is scored from a parent-child interaction during play and snack using a modified version of the Weighted Frequency of Intentional Communication (WFIC) coding scheme (Yoder et al., 2021a), which quantifies the maturity of the form and frequency of intentional communication in young children with social communication delays. Coders transcribed and coded all non-imitated communicative utterances, including gestures, contingent vocalizations, single-words, simple phrases, and sentences. Each utterance was weighted (1-4) based on its complexity. Utterances are summed to produce a weighted frequency. Weighted frequency was were converted to a rate per minute by dividing the score by the length of the video. Values were log transformed to improve normality of distribution. Values ranged from -1.30 to 1.57 with higher values indicated higher weighted frequency of intentional communication. Means are adjusted for their T1 measure.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Weighted Frequency of Intentional Communication
|
.62 log(utterances per minute)
Standard Error .07
|
.64 log(utterances per minute)
Standard Error .07
|
.64 log(utterances per minute)
Standard Error .08
|
PRIMARY outcome
Timeframe: Follow up (9 months)Equally weighted composite score of child expressive language ability derived from MacArthur Bates Communicative Development Inventory (MB-CDI), Mullen Scales of Early Learning (MSEL) Expressive Language raw score, and Vineland Adaptive Behavior Scales (VABS) Expressive Language raw score. Measures were z-score transformed and averaged. Z-score of 0 represents mean for the participants. Positive z-score represent a better outcome.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Child Expressive Language Ability
|
.08 units on a scale
Standard Error .12
|
-.05 units on a scale
Standard Error .12
|
-.04 units on a scale
Standard Error .13
|
SECONDARY outcome
Timeframe: Post-Treatment (6 months)Parents complete the 8-item Positive Impact subscale of the Family Impact Questionnaire (FIQ; Donenberg \& Baker, 1993) as a measure of their perception of their child's positive impact on their experience as a parent. Parents endorsed items comparing their experience with their child to parents with same-aged typically-developing peers on a 4-point scale; higher sum scores indicate greater positive impact. Scores could range from 8 to 32.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Family Impact Questionnaire
|
22 units on a scale
Standard Error 1.34
|
23.08 units on a scale
Standard Error 1.16
|
20.18 units on a scale
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Post-Treatment (6 months)Parents complete the Parenting Stress Index, Short Form (PSI-SF; Abidin, 1995), a 36-item measure of parenting stress. Parents rated items on a 5-point scale. Items are summed with higher scores indicating greater parenting stress. The Total Stress scale was used as a measure of parenting stress. Raw Scores could range from 36 to 180.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Parenting Stress Index-Short Form
|
92.69 score on a scale
Standard Error 4.33
|
90.76 score on a scale
Standard Error 4.39
|
97.50 score on a scale
Standard Error 5.20
|
SECONDARY outcome
Timeframe: Follow up (9 months)The Mullen Scales of Early Learning (MSEL; Mullen, 1995) is a standardized developmental test for young children that assesses skills in expressive language, receptive language, visual reception, and fine motor. The raw score for the Expressive Language scale was used in analyses. Raw scores ranged from 7 to 47. Higher scores indicate better language outcomes. Means are adjusted for their T1 measure.
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Mullen Scales of Early Learning
|
23.88 score on a scale
Standard Error 1.40
|
22.71 score on a scale
Standard Error 1.90
|
23.12 score on a scale
Standard Error 1.46
|
SECONDARY outcome
Timeframe: Follow up (9 Months)MacArthur-Bates Communicative Development Inventory (MCDI; Fenson et al., 2006) is a parent report instrument that measures early language development, including productive vocabulary. Parents complete either the Words and Gestures Form or Words and Sentences Form, depending on their child's predominant method of communication online. The total number of words parents reported that their child "understands and says" (Words and Gestures Form) or "words produced" (Words and Sentences Form) is used in analyses. Means are adjusted for their T1 measures
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
MacArthur-Bates Communicative Development Inventory
|
328.68 number of words
Standard Error 31.38
|
270.52 number of words
Standard Error 33.21
|
282.85 number of words
Standard Error 36.73
|
SECONDARY outcome
Timeframe: Follow up (9 Months)The VABS is a standardized parent interview that assesses adaptive functioning in four domains: communication, socialization, daily living skills, and motor skills. The raw score for the Expressive Language subdomain was used in analyses. Raw scores ranged from 10 to 99. Higher scores indicate better language outcomes. Means are adjusted for their T1 measures
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
n=18 Participants
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Vineland Adaptive Behavior Scales, 2nd Edition
|
48.04 score on a scale
Standard Error 2.61
|
46.39 score on a scale
Standard Error 2.72
|
44.30 score on a scale
Standard Error 3.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-treatment (6 months)ImPACT Online electronic tracking system. % of learning activities accessed
Outcome measures
| Measure |
Parent: Self-Directed Group
n=24 Participants
Parent participants assigned to the self-directed group will receive access to the secure, password-protected, ImPACT Online web-based program for four months. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. The web application contains 12, self-directed lessons, each of which takes approximately 75 minutes to complete. Parent participants will be encouraged to complete one lesson per week and to practice the intervention techniques with their child between each lesson. Each lesson consists of a Narrated Slideshow with embedded video clips, a Written Manual, a self-check quiz, short interactive exercises, a Homework Plan, and reflection questions. Parent participants in the self-directed group may contact project staff via phone or email for assistance with technology-related problems (e.g., difficulty with logins, problems playing video). However, they will receive no assistance or support in learning the intervention from project staff outside of the self-directed web-based program.
|
Parent: Therapist-Assisted Group
n=22 Participants
Parent participants assigned to the therapist-assisted group will be given access to the ImPACT Online web-based program for four months and will be encouraged to work through the program at the same pace as the self-directed group. The intervention content was adapted from Project ImPACT, a manualized NDBI parent training curriculum. Parent participants will also receive 2, 30-minute remote coaching sessions per week (24 total sessions) via video conferencing software by a trained therapist to assist them in learning the intervention. The first coaching session of the week will involve the coach and participant and will be used to help clarify the content of the relevant lesson and help the parent participant apply the lesson content to their own child. The second coaching session of the week will involve the coach, participant, and child and will be used to provide the participant with "live" feedback on their use of the intervention techniques as they practice with their child.
|
Parent: Information and Resource Support Control Group
Parent participants assigned to the web-based information control group will be given access the Resources page with links to the same ASD information websites, but will not receive access to other aspect of the ImPACT Online program. This condition will be used to control for child participant maturation as well as the potentially confounding effect of parent participants having access to autism-related information via the internet.
|
|---|---|---|---|
|
Program Engagement
|
58.57 percent
Standard Deviation 36.93
|
96.29 percent
Standard Deviation 7.29
|
—
|
Adverse Events
Parent: Self-Directed Group
Parent: Therapist-Assisted Group
Parent: Information and Resource Support Control Group
Child: Self-Directed Group
Child: Therapist-Assisted Group
Child: Information and Resource Support Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place