Trial Outcomes & Findings for Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder (NCT NCT03984487)

Last Updated: 2024-07-23

Results Overview

The VABS-3 is a well-established standardized measure of adaptive behavior that assesses skills in the Communication, Daily Living Skills, and Socialization domains. The Daily Living Skills domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention. We are reporting the average (mean) Daily Living Skills Domain Raw Scores, both at baseline at post-treatment. The range for total raw score for the entire domain is 0 to 286. The higher the score, the more independent they are at overall daily living skills.

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

4 months (from baseline to post-intervention)

Results posted on

2024-07-23

Participant Flow

We recruited using flyers via our hospital's outpatient autism clinic, research databases, and within the community.

We had several screen fails, which we compensated for by enrolling above our target number for completion. Randomization was stratified based on IQ (i.e., IQ\>85 and IQ\<85).

Participant milestones

Participant milestones
Measure	STRW Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW). Surviving and Thriving in the Real World: The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning DLS and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).	PEERS Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS). Program for the Education and Enrichment of Relational Skills: PEERS is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
Overall Study STARTED	36	37
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daily Living Skills Intervention for Adolescents With Autism Spectrum Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STRW n=36 Participants Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW). Surviving and Thriving in the Real World: The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning DLS and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).	PEERS n=37 Participants Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS). Program for the Education and Enrichment of Relational Skills: PEERS is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	37 participants n=7 Participants	73 participants n=5 Participants
IQ IQ <70	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
IQ IQ >70	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months (from baseline to post-intervention)

Outcome measures

Outcome measures
Measure	STRW n=31 Participants Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW). Surviving and Thriving in the Real World: The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning DLS and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).	PEERS n=30 Participants Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS). Program for the Education and Enrichment of Relational Skills: PEERS is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
Vineland Adaptive Behavior Scales, 3rd Edition DLS Domain Raw Scores - Baseline	195.7 Score on a scale Standard Deviation 4.6	201.7 Score on a scale Standard Deviation 4.7
Vineland Adaptive Behavior Scales, 3rd Edition DLS Domain Raw Scores - Post-treatment	232.2 Score on a scale Standard Deviation 4.4	227.9 Score on a scale Standard Deviation 4.4

Adverse Events

STRW

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

PEERS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	STRW n=31 participants at risk Participants will receive the daily living skills intervention, Surviving and Thriving in the Real World (STRW). Surviving and Thriving in the Real World: The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning DLS and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).	PEERS n=30 participants at risk Participants will receive a social skills intervention, Program for the Education and Enrichment of Relational Skills (PEERS). Program for the Education and Enrichment of Relational Skills: PEERS is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
Psychiatric disorders Self Injury	3.2% 1/31 • Number of events 1 • anywhere from 1 year to 16 months per participant, depending on which intervention they were randomized to (groups were run consecutively, not concurrently). Definition does not differ from CT. gov.	0.00% 0/30 • anywhere from 1 year to 16 months per participant, depending on which intervention they were randomized to (groups were run consecutively, not concurrently). Definition does not differ from CT. gov.
Psychiatric disorders Inpatient stay	3.2% 1/31 • Number of events 1 • anywhere from 1 year to 16 months per participant, depending on which intervention they were randomized to (groups were run consecutively, not concurrently). Definition does not differ from CT. gov.	0.00% 0/30 • anywhere from 1 year to 16 months per participant, depending on which intervention they were randomized to (groups were run consecutively, not concurrently). Definition does not differ from CT. gov.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amie Duncan

Cincinnati Children's Hospital

Phone: 513-803-2416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place