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Completed

NCT Number: NCT05256095

Thinking in Speech for Children With Autism

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".

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders Speech Verbal Behavior

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thinking in Speech

Behavioral

Thinking in Speech is a therapy to help children with autism learn to cope with daily stressors and improve their communication.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Thinking in Speech therapy sessions attended among all participants

    Time frame: Up to 20 weeks

    Number of sessions attended will be calculated for each participant

  2. Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anger Measure to Post-Intervention

    Time frame: Up to 20 weeks

    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.

  3. Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anxiety Short Form to Post-Intervention

    Time frame: Up to 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Thinking in Speech for Children With Autism - Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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