Clinical trial NCT05256095: Thinking in Speech for Children With Autism
Official title: Thinking in Speech for Children With Autism - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Speech
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All participants will receive the Thinking in Speech Therapy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Number of Thinking in Speech therapy sessions attended among all participants
timeFrame: Up to 20 weeks
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anger Measure to Post-Intervention
timeFrame: Up to 20 weeks
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anxiety Short Form to Post-Intervention
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Barbara Baumann, PhD
role: PRINCIPAL_INVESTIGATOR
References: