Autism Spectrum DisorderNCT05256095
Thinking in Speech for Children With Autism
A study testing Thinking in Speech in people with Autism Spectrum Disorder and Speech, run by University of Pittsburgh at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder, Speech
- What is being tested?
- Thinking in Speech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Thinking in Speech for Children With Autism - Pilot Study
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".
Read the 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.
- Conditions
- Autism Spectrum Disorder, Speech
- Being tested
- Thinking in Speech
- Medical subject headings
- Autism Spectrum Disorder, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking in SpeechBehavioural
Thinking in Speech is a therapy to help children with autism learn to cope with daily stressors and improve their communication.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Assignment to Intervention Group | Experimental | 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. Receives: Behavioral: Thinking in Speech |
| Waitlist Assignment to Intervention Group | Experimental | 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. Receives: Behavioral: Thinking in Speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 weeks
Secondary outcomes (3)
Number of Thinking in Speech therapy sessions attended among all participants
Number of sessions attended will be calculated for each participant
Measured: Up to 20 weeks
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.
Measured: Up to 20 weeks
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.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start12 May 2021
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- All participants will receive the Thinking in Speech Therapy
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Baumann, University of Pittsburgh
- Investigators
- Barbara Baumann, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256095
- Sponsor's protocol ID
- STUDY20060157
- Status last verified
- Oct 2024
- First submitted
- 15 Feb 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thinking in Speech for Children With Autism - Pilot Study
- ClinicalTrials.gov ID
- NCT05256095
- Acronym / sponsor ID
- STUDY20060157
- Conditions
- Autism Spectrum Disorder, Speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive the Thinking in Speech Therapy
| Arm | Type | Receives |
|---|---|---|
| Immediate Assignment to Intervention Group | Experimental | Behavioral: Thinking in SpeechThis 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. |
| Waitlist Assignment to Intervention Group | Experimental | Behavioral: Thinking in SpeechThe 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thinking in SpeechThinking in Speech is a therapy to help children with autism learn to cope with daily stressors and improve their communication. | Behavioural | Immediate Assignment to Intervention Group, Waitlist Assignment to Intervention Group |
Primary outcome
Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention
Time frame: Up to 20 weeks
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.
3 secondary outcomes
Number of Thinking in Speech therapy sessions attended among all participants
Time frame: Up to 20 weeks
Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anger Measure to Post-Intervention
Time frame: Up to 20 weeks
Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anxiety Short Form to Post-Intervention
Time frame: Up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Baumann, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking in Speech in people with Autism Spectrum Disorder and Speech, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention (time frame: Up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.