Thinking in Speech for Children With Autism

NCT05256095 | Completed

• 1 other identifier: STUDY20060157
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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".

Conditions

Autism Spectrum Disorder; Speech

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 20 weeks

Secondary Outcomes (3)

• Number of Thinking in Speech therapy sessions attended among all participants

  Up to 20 weeks

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

  Up to 20 weeks

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

  Up to 20 weeks

Study Arms (2)

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.

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.

Behavioral: Thinking in Speech

Interventions

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.

Immediate Assignment to Intervention Group; Waitlist Assignment to Intervention Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Speech

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior

Study Officials

• Barbara Baumann, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Instructor in Psychiatry

Model Details: All participants will receive the Thinking in Speech Therapy

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: May 12, 2021
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)