Oxytocin-induced enhancement of Social Skills Training in Adolescents with ASD

Phase 3

Conditions: Pervasive developmental disorders
F84

Registration Number: DRKS00008952

Lead Sponsor: Zentralinstitut für seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Male

Target Recruitment: 168

Inclusion Criteria

1) High-functioning autism (F84.0), Asperger syndrome (F84.5), Atypical autism (F84.1), confirmed by ADOS2 and ADI-R Ratings
2) Gender: male
3) age 12 = years = 18
4) IQ >=80
5) fluent use of german language

Exclusion Criteria

1) psychotic disorder, major depressive episode with suicidal ideation, social anxiety, , any personality disorder 2) metal parts in the body 3) cardiovascular and endocrinological disorders 4) hypersensitivity to Oxytocin 5) other medical disorder interfering with therapy 6) aggressive behaviour interfering with group therapy 7) group-based social Skill training during the last 6 months prior to study 8) changes to medication in the foreseeable future

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a primary efficacy endpoint for the effectiveness of oxytocin during the social skill training we chose the changes on the SRS score over time. Changes in the social reciprocity: SRS-Score parents (T1 vs. T2, T1 vs. T3, T1 vs. T4)<br>T1: Baselinemeasurement shortly before the social skill training<br>T2: Post-measurement shortly after the social skill training<br>T3: Follow upI 3 months after the social skill training <br>T4: Follow upII 6 months after the social skill training

Secondary Outcome Measures

Name	Time	Method
Changes in the social reciprocity: SRS Score Teacher (T1 vs. T2, T1 Vs. T3, T1 vs. T4), Changes in ability for emotional empathy (MET-J) (T1 vs. T2), Changes in depressive symptoms (DIKJ) (T1 vs. T2, T1 vs. T3, T1 vs. T4), changes in biological stress reaction: diurnal cortisol-levels (saliva) (T1 Vs. T2), changes in stress and copingstrategies: SSKJ (T1 vs. T2, T1 vs. T3, T1 vs. T4), changes in anxiety: AFS (T1 T2, T1 vs. T3, T1 vs. T4), changes in quality of life: CHIP-CE (parents) and KIDDO-KINDL (patients) (T1 vs. T2, T1 vs. T3, T1 vs. T4), temper and personality via JTCI are assesed as possible predictors and control variables