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Thinking in Speech for Children With Autism

Primary Purpose

Autism Spectrum Disorder, Speech

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thinking in Speech
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Verbal language ability as reported by the caregiver
  • Ages 7-11
  • Prior autism or related neurocognitive diagnosis
  • Child proficient in English
  • Caregiver proficient in English
  • Residing in Pennsylvania
  • Access to internet at home

Exclusion Criteria:

  • History of major child mental illness (e.g., bipolar, schizophrenia, psychosis)
  • Child visual and/or hearing impairment that interferes with his/her ability to participate in therapy

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Assignment to Intervention Group

Waitlist Assignment to Intervention Group

Arm Description

This group will begin to receive the intervention immediately upon entering the study. Thinking in Speech is a novel cognitive therapy that helps children with autism independently cope with everyday events that cause stress, by developing their ability to use inner speech. Participants will complete two sessions per week for eight week, for a total of sixteen sessions. Sessions will be conducted by speech-language pathologists who are trained in Thinking in Speech. Sessions will be conducted via a secure Zoom platform.

The Waitlist group will begin to receive the intervention 10 weeks after entering the study. Thinking in Speech is a novel cognitive therapy that helps children with autism independently cope with everyday events that cause stress, by developing their ability to use inner speech. Participants will complete two sessions per week for eight week, for a total of sixteen sessions. Sessions will be conducted by speech-language pathologists who are trained in Thinking in Speech. Sessions will be conducted via a secure Zoom platform.

Outcomes

Primary Outcome Measures

Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention
This measure assesses participants' emotion dysregulation via a 30-item measure. 24 items measure reactivity and 6 items measure dysphoria. A raw score is created by summing the items for each subscale, and ranges from 0-96. Higher scores indicate greater emotion dysregulation and lower scores indicate less emotional dysregulation. Participants will be assessed using this measure at baseline and after therapy is completed.

Secondary Outcome Measures

Number of Thinking in Speech therapy sessions attended among all participants
Number of sessions attended will be calculated for each participant
Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anger Measure to Post-Intervention
The PROMIS Anger item banks assess self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. Often associated with episodes of frustration that impede goal-directed behavior, anger is marked by attitudes of hostility and cynicism. Specific components relate to verbal and non-verbal evidence of anger. Physical aggression items are not included. The anger short forms are universal rather than disease-specific. All assess anger over the past seven days. The values are summed to create a total score and scores range from 5-25, with higher scores indicating greater levels of anger and lower scores indicated lower levels of anger.
Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anxiety Short Form to Post-Intervention
The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Only one behavioral avoidance item is included in the adult item bank; therefore, behavioral fear avoidance is not fully evaluated. The anxiety measures are universal rather than disease-specific. All assess anxiety over the past seven days. Responses are summed to create a total score ranging from 8-40. Higher scores reflect greater levels of anxiety and lower scores reflect less anxiety.

Full Information

First Posted
February 15, 2022
Last Updated
October 6, 2022
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05256095
Brief Title
Thinking in Speech for Children With Autism
Official Title
Thinking in Speech for Children With Autism - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examines a cognitive therapy for autistic children, Thinking in Speech. Thinking in Speech helps children with autism independently cope with everyday events that cause stress, by developing their ability to use "inner speech".
Detailed Description
The purpose of this study is to examine the effectiveness of Thinking in Speech (TiS) in teaching children to identify when they are experiencing a problem and learn to ask for help appropriately. Participants. Participants will be 20 verbal children, aged 7-11, who have been diagnosed with autism or related neurocognitive disorders. Therapists will be experienced and certified speech-language pathologists (SLPs) who will be trained to use TiS For this grant, investigators will develop a standardized training program that can be administered to community SLPs. Training will consist of background reading and discussions, analysis of past therapy sessions, and practice sessions with individualized feedback provided by a trainer. Training will focus on developing the child's ability to ask for help. Asking for help requires a complex combinations of executive functions and being able to adopt the perspective of another person. Training sessions will be recorded for use in further training development and enhancements. A five-week training program is anticipated. Procedure: Both training and therapy will be delivered remotely. The therapists will plan to conduct sixteen 30-minute remote therapy sessions over 8 weeks - the actual time frame will depend on the health and scheduling demands of the therapists and children. All TiS sessions will be video-recorded. Children will be randomly assigned to either receive therapy immediately or to be placed on a 10-week wait-list after which they will receive therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Speech

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
All participants will receive the Thinking in Speech Therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Assignment to Intervention Group
Arm Type
Experimental
Arm Description
This group will begin to receive the intervention immediately upon entering the study. Thinking in Speech is a novel cognitive therapy that helps children with autism independently cope with everyday events that cause stress, by developing their ability to use inner speech. Participants will complete two sessions per week for eight week, for a total of sixteen sessions. Sessions will be conducted by speech-language pathologists who are trained in Thinking in Speech. Sessions will be conducted via a secure Zoom platform.
Arm Title
Waitlist Assignment to Intervention Group
Arm Type
Experimental
Arm Description
The Waitlist group will begin to receive the intervention 10 weeks after entering the study. Thinking in Speech is a novel cognitive therapy that helps children with autism independently cope with everyday events that cause stress, by developing their ability to use inner speech. Participants will complete two sessions per week for eight week, for a total of sixteen sessions. Sessions will be conducted by speech-language pathologists who are trained in Thinking in Speech. Sessions will be conducted via a secure Zoom platform.
Intervention Type
Behavioral
Intervention Name(s)
Thinking in Speech
Intervention Description
Thinking in Speech is a therapy to help children with autism learn to cope with daily stressors and improve their communication.
Primary Outcome Measure Information:
Title
Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention
Description
This measure assesses participants' emotion dysregulation via a 30-item measure. 24 items measure reactivity and 6 items measure dysphoria. A raw score is created by summing the items for each subscale, and ranges from 0-96. Higher scores indicate greater emotion dysregulation and lower scores indicate less emotional dysregulation. Participants will be assessed using this measure at baseline and after therapy is completed.
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Number of Thinking in Speech therapy sessions attended among all participants
Description
Number of sessions attended will be calculated for each participant
Time Frame
Up to 20 weeks
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anger Measure to Post-Intervention
Description
The PROMIS Anger item banks assess self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. Often associated with episodes of frustration that impede goal-directed behavior, anger is marked by attitudes of hostility and cynicism. Specific components relate to verbal and non-verbal evidence of anger. Physical aggression items are not included. The anger short forms are universal rather than disease-specific. All assess anger over the past seven days. The values are summed to create a total score and scores range from 5-25, with higher scores indicating greater levels of anger and lower scores indicated lower levels of anger.
Time Frame
Up to 20 weeks
Title
Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anxiety Short Form to Post-Intervention
Description
The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Only one behavioral avoidance item is included in the adult item bank; therefore, behavioral fear avoidance is not fully evaluated. The anxiety measures are universal rather than disease-specific. All assess anxiety over the past seven days. Responses are summed to create a total score ranging from 8-40. Higher scores reflect greater levels of anxiety and lower scores reflect less anxiety.
Time Frame
Up to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Verbal language ability as reported by the caregiver Ages 7-11 Prior autism or related neurocognitive diagnosis Child proficient in English Caregiver proficient in English Residing in Pennsylvania Access to internet at home Exclusion Criteria: History of major child mental illness (e.g., bipolar, schizophrenia, psychosis) Child visual and/or hearing impairment that interferes with his/her ability to participate in therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Baumann, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Thinking in Speech for Children With Autism

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