Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Clinical and Cost Effectiveness of a Parent Mediated Intervention to Reduce Challenging Behaviour in Pre-schoolers With Moderate to Severe Learning Disability: a Randomised Controlled Trial
Brief Summary: Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.


Options:
A: Arm Label: Adult bipolar patients; Type: N/A; Interventions: N/A | Arm Label: Adult Extended Relatives of BD probands; Type: N/A; Interventions: N/A | Arm Label: Bipolar Children and Youth; Type: N/A; Interventions: N/A | Arm Label: Child/Adolescent Extended Relatives of BD probands; Type: N/A; Interventions: N/A | Arm Label: Children with ADHD only (controls); Type: N/A; Interventions: N/A | Arm Label: First degree relatives of BD patients; Type: N/A; Interventions: N/A | Arm Label: Healthy volunteer adults (parents or not); Type: N/A; Interventions: N/A | Arm Label: Healthy volunteer children and youth; Type: N/A; Interventions: N/A
B: Arm Label: Stepping Stones Triple P; Type: EXPERIMENTAL; Interventions: Behavioral: Level 4 Stepping Stones Triple P (SSTP) | Arm Label: Treatment as usual (TAU); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Level 4 Stepping Stones Triple P (SSTP); Assigned to Arm(s): Stepping Stones Triple P
C: Arm Label: Cognitus and Me; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive remediation program | Arm Label: control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive remediation program | Intervention Type: BEHAVIORAL; Name: Cognitive remediation program; Assigned to Arm(s): Cognitus and Me, control group
D: Arm Label: Children/adolescents with ADHD; Type: N/A; Interventions: Drug: Lithium | Arm Label: Children/Adolescents with DMDD or subthreshold DMDD; Type: N/A; Interventions: Drug: Lithium | Arm Label: Children/adolescents with MDD; Type: N/A; Interventions: N/A | Arm Label: Healthy volunteer adults; Type: N/A; Interventions: N/A | Arm Label: Healthy volunteer children/adolescents; Type: N/A; Interventions: N/A | Arm Label: Parents of children/adolescents with DMDD or subthreshold DMDD; Type: N/A; Interventions: N/A | Intervention Type: DRUG; Name: Lithium; Assigned to Arm(s): Children/Adolescents with DMDD or subthreshold DMDD, Children/adolescents with ADHD

Answer: B