Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: Participants are parents of children diagnosed with autism aged between 2 and 5 years 11 months of age who are referred (or self‐refer) to the Sydney Child behaviour Research Clinic, and would like assistance managing child disruptive behaviour. Participants randomly allocated to the ParentWorks Spectrum will receive 12 (one hour) 1:1 weekly sessions with a trained clinician. The intervention follows a structured treatment manual and the components of this intervention have been developed from current evidence‐based treatments to address child externalising behaviours (Module 1; sessions 1‐4); parent‐child reciprocity and child social‐communication skills (Module 2; sessions 5‐9); and parental wellbeing (Module 3; sessions 10‐12). While the treatment is 12 sessions in duration, up to 15 sessions can be provided in order to provide additional time for the content to be delivered where needed. The assessment and intervention will be delivered online via the platform Zoom. Throughout treatment, clinicians work collaboratively with parents to deliver intervention strategies that target child behavioural difficulties, parent‐child interactions, in addition to parental stress and parenting difficulties experienced in the context of parenting a child with autism. Strategies will be taught to parents through active skills training and will involve role‐plays, modelling, rehearsing and feedback. This intervention will be delivered by utilising the manual, ParentWorks Spectrum: A parent mediated intervention for young children with autism (Leonard, Hawes, Tully, Eapen & Dadds, 2019). Clinician adherence to treatment content and manual will be monitored using weekly clinician checklists that are developed specifically for this study. Furthermore, sessi CONDITION: Autism Spectrum Disorder;Behavioral Disorders; ; Autism Spectrum Disorder ; Behavioral Disorders Mental Health ‐ Autistic spectrum disorders SECONDARY OUTCOME: A videotaped observation of parent‐child interaction will be coded for parenting practices (responsiveness and positive parenting), and child social communication skills and disruptive behaviours. Parent‐child interactions will be coded using the Behavioural Observation Coding System: Family Observation Schedule (FOS, 5th edition; Hawes et al., 2013) that has been specifically adapted for this study.[The videotaped observation of parent‐child interaction will be conducted and coded at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only). Only the primary caregiver will participate in the videotaped observation.] Child adaptive functioning will be assessed using the adaptive behaviour composite that consists of the communication, daily living skills, socialisation domains on the parent form of the Vineland‐3 (Sparrow, Cicchetti, & Saulnier, 2016). This measure will be completed by the main caregiver only.[The Vineland‐3 will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Child emotional and behavioural symptoms will be assessed with the total score and subscale scores (emotional symptoms, conduct problems, hyperactivity‐inattention, peer relationship problems, and prosocial behaviours) on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001), a parent‐report questionnaire completed by all participating parents (both mothers and fathers). [The SDQ will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Global functioning of the child will be assessed by the Children’s Global Assessment Scale (CGAS; Wagner et al., 2007). The CGAS will be rated by the treating clinician (at baseline) and a blind clinician (blind to intervention group and pre‐treatment rating; at post‐assessment and follow‐up).[The CGAS will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Inter‐parental conflict/team work between parents who operate as parenting teams will be assessed with the Intensity and Problem scales on the Parent Problem Checklist (PPC; Dadds & Powell, 1991), a parent‐completed measure completed by all participating parents (both mothers and fathers).[The PPC will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Parental well‐being will be assessed using the short version of the Depression Anxiety Stress Scales (DASS‐21; Lovibond & Lovibond, 1995), a parent‐completed measure completed by all participating parents (both mothers and fathers). The depression, anxiety and stress scales and total score will be used. The DASS subscale scores are not considered composite or separate outcomes. Instead, the subscales and total scores will be analysed together in a MANOVA as they are correlated and will not be analysed as separate variables. This applies to many of the secondary outcomes where questionnaires contain multiple subscales. [The DASS‐21 will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Parenting practices will be assessed with the total and subscale scores (overreactivity, laxness and hostility) from the Parenting Scale (PS; Arnold, O'leary, Wolff, & Acker, 1993; Rhoades & O'Leary, 2007). This measure is completed by all participating parents (both mothers and fathers).[The PS will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Parents’ sense of competence will be assessed with the total and subscale scores (efficacy and satisfaction) on the Parenting Sense of Competency scale (PSOC; Johnston & Mash, 1989), completed by all participating parents (both mothers and fathers).[The PSOC will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Teacher report on child emotional and behavioural symptoms will be assessed with the total score and subscale scores (emotional symptoms, conduct problems, hyperactivity‐inattention, peer relationship problems, and prosocial behaviours) on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001).[Teacher report on the SDQ will be completed at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Teacher/educator report of child externalising behaviours will be assessed with the Intensity and Problem scales of the Sutter‐Eyberg Student Behaviour Inventory (SESBI–R; Eyberg & Pincus, 1999).[The SESBI–R will be administered at baseline, post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] INCLUSION CRITERIA: Inclusion criteria include: 1.Parents/caregivers of children aged 2 to 5 years 11 months with a diagnosis of autism at baseline; 2. Parents must be able to access high speed internet via computer or tablet (not smart phone) to participate in the intervention and attend weekly sessions (via Zoom) for 12 weeks; 3. Parents comfortable completing questionnaires and treatment sessions in English; 4. If child is receiving medication for behaviour, must be stable on current dose for 4 weeks, with no planned changes to medication regime; 5. Parents would like assistance in managing child disruptive behaviours. PRIMARY OUTCOME: Child diagnostic profiles will be assessed using the Diagnostic Interview Schedule for Children, Adolescents and Parents– DISCAP (Johnson, Barrett, Dadds, Fox, and Shortt, 1999). The DISCAP is a reliable diagnostic system administered by a psychologist to parents in order to make DSM‐5 diagnoses, and will be used to conduct a comprehensive diagnostic profile for each child. Blind checks will be used to examine the reliabilities using a secondary team of psychologists to check the diagnosis made by the primary clinician. This diagnostic system is a reliable indicator of externalizing and internalizing disorders and provides clinicians with a severity rating. A composite variable of severity of externalising behaviours (Oppositional Defiant Disorder (ODD) and/or Conduct Disorder (CD)) specifically will be the primary outcome for this study. ODD and CD diagnoses will be used as an indicator of externalising behavioural issues collapsed into the one composite primary outcome—the child’s diagnostic profile. The DISCAP will be completed by the treating clinician (at baseline) and by a blind clinician (blind to intervention group and pre‐treatment diagnosis and severity) at intervention completion and three month follow‐up.; [The DISCAP will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] Child Externalising behaviours will be assessed with the Intensity and Problem scales of the Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999), a parent‐report measure completed by all participating parents (both mothers and fathers).[The primary outcomes on the ECBI will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).] The severity of autism symptoms will be assessed with the total score and subscale scores (social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behaviours) on the Social Responsiveness Scale (SRS; Constantino & Gruber, 2012), a parent‐report measure completed by all participating parents (both mothers and fathers).[The SRS will be administered at baseline and post‐assessment (12 weeks post‐baseline; intervention, waitlist control), and three month follow‐up (24 weeks post‐baseline; intervention group only).]
Epistemonikos ID: 77f2ed84e2e65ec73892161af903ffc3cfc6f64f
First added on: Aug 25, 2024